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  • A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRC1 Carriers. - NCT04251052

    Primary Objective: - To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germline mutations. Secondary Objectives: - To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACT-ES subscale compared to women in the BSO arm. To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients. - To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice. - To assess adverse events, graded using CTCAE v5.0.

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    • Protocol Number:
      102005

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Individuals 35-50 years of age, inclusive
    • Patients who are undergoing risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
    • At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and fallopian tube (with fimbria not removed) are present
    • Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
    • Patients may be premenopausal or menopausal
    • Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
    • Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future

    Exclusion Criteria:

    • Individuals with a history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
    • Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
    • Patients medically unfit for the planned surgical procedure
    • Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days
    • An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary)
    • An abnormal CA-125 is defined as a level > 50 U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal individuals who are current users of oral contraceptives. An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer - NCT05226507

    Primary: To identify the MTD and dose for Part B by: Evaluating the safety profile of escalating doses and different schedules of NXP800. Identification of DLTs. Secondary: To evaluate the PK profile of NXP800. Exploratory: To describe the antitumor activity of NXP800 in various tumor types. To describe the effect of NXP800 on tumor markers (where applicable). To describe the treatment effect of NXP800 on pharmacodynamic markers.

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    • Protocol Number:
      052306

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      NXP800

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Part A Inclusion Criteria:

    • Provide written informed consent.
    • 18 years old or older.
    • Life expectancy of at least 12 weeks.
    • Histologically- or cytologically-confirmed, advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator (in Part B, subjects with specific cancer types will be enrolled; Specific criteria will be introduced in a protocol amendment).
    • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
    • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

    Part A Exclusion Criteria:

    • Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
    • Ongoing toxic manifestations of previous treatments > Grade 2.
    • Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 28 days after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
    • Female subjects who can become pregnant (or are already pregnant or lactating).
    • Male subjects with partners of childbearing potential (unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence).

      Part B Inclusion Criteria:

      • Provide written informed consent.
      • 18 years old or older.
      • Subjects with the following ARID1a mutated, ovarian/fallopian tube/primary peritoneal cancer histologies (ARID1a mutation status determined by a DNA-based Next Generation Sequencing test):
      • Clear cell ovarian carcinoma (≥ 50% clear cell carcinoma with no serous differentiation)
      • Endometrioid ovarian carcinoma
      • Subjects must have disease progression within 6 months (182 days) from completion of platinum-based therapy (6 months should be calculated from the date of the last administered dose of platinum therapy to the date of radiographic imaging showing progression)
      • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
      • Subjects with a BRCA mutation must have received prior treatment with a PARP inhibitor.
      • Subjects must have received at least 1 but not more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab.
      • Adjuvant + neoadjuvant are considered one line of therapy
      • Maintenance therapy (i.e., bevacizumab, PARP inhibitors) will be considered as part of the preceeding line of therapy and are not counted independently.
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
      • Subjects must have a sufficient archival Formalin-Fixed Paraffin-Embedded (FFPE) tissue specimen, or be willing to consent to a fresh tissue biopsy during the study.

      Part B Exclusion Criteria:

      • Subjects with disease that did not respond to, or has progressed during or within 4 weeks of the last dose of first-line platinum containing chemotherapy.
      • Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800.
      • Ongoing toxic manifestations of previous treatments > Grade 2, with the exception of alopecia.
      • Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 12 weeks while off corticosteroids after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
      • Female subjects who can become pregnant (or are already pregnant or lactating).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination with Niraparib in Subjects with Platinum-Resistant Ovarian Cancer. - NCT05198804

    Primary Objectives: Phase 1: To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D. Phase 2: To investigate the antitumor activity of ZN-c3 in combination with niraparib. Secondary Objectives: - To further investigate the antitumor activity of ZN-c3 in combination with niraparib. - To investigate the OS of subjects receiving ZN-c3 in combination with niraparib. - To investigate the safety and tolerability of ZN-c3 in combination with niraparib. - To evaluate changes in PROs and quality of life. - To investigate the plasma PK of ZN-c3 and niraparib when given in combination.

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    • Protocol Number:
      102204

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ZN-c3 Niraparib

      • Contacts:

      • New Jersey Medical School Prinicipal Investigator: Mark Einstein M.D

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Female and at least 18 years old. 2. Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometrial for which there is no known or established treatment available with curative intent. 3. Have demonstrated relapse within 6 months of platinum therapy (platinum-free interval <6 months). 4. Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured. 5. Adequate hematologic and organ function. 6. Ability and willingness to take oral medication. 7. If unknown homologous recombination deficiency (HRD) status, subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation. 8. Willingness to release archival tissue for research purposes or to undergo a tumor tissue biopsy prior to dosing on Cycle 1 Day 1.

      Additional Key Inclusion Criteria for Phase II:

        9. This supersedes inclusion criterion 3 (above). Demonstrated relapse within 6 months of platinum therapy, while taking a PARPi as maintenance: a minimum of 3 months is required if the participant received PARPi maintenance following first-line chemotherapy. 10. Must have measurable disease according to RECIST V1.1 criterion: defined as at least one lesion that can be accurately measured.

      Key Exclusion Criteria:

        1. Prior therapy directed at the malignant tumor within the last four weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C). 2. A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required. 3. Any investigational drug therapy <28 days. 4. Prior treatment with a WEE1 inhibitor. 5. Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients. 6. Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 7. Uncontrolled hypertension (Diastolic BP > 90 mmHg or Systolic BP > 140 mmHg). 8. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV). 9. Significant gastrointestinal abnormalities, requirement for IV alimentation, active peptic ulcer, chronic diarrhea, or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption. 10. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. 11. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP). 12. Taking medications with a known risk of TdP (according to current information provided at https://crediblemeds.org).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

  • A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors - NCT05252416

    Primary Phase 1: To determine the MTD and RP2D of BLU-222 monotherapy and in combination with carboplatin, or ribociclib and fulvestrant To evaluate the safety and tolerability of BLU-222 monotherapy and in combination with carboplatin, or ribociclib and fulvestrant Phase 2 To assess the anticancer activity of BLU-222 at the RP2D in patients with advanced solid tumors, as a monotherapy and in combination with carboplatin, fulvestrant, or ribociclib and fulvestrant To evaluate the safety and tolerability of BLU-222 monotherapy and in combination with carboplatin, fulvestrant, or ribociclib and fulvestrant Secondary Phase 1 To assess anticancer activities of BLU-222 monotherapy and in combination with carboplatin, or ribociclib and fulvestrant To characterize the PK profile of BLU-222 monotherapy and in combination with carboplatin, or ribociclib and fulvestrant and correlate drug exposure with safety assessments and antitumor activity To evaluate the effect of a high-fat meal on the PK of BLU-222 To evaluate the relative bioavailability of 1st and 2nd generations of BLU-222 capsules To assess treatment-induced modulation of cyclin E/CDK2 pathway biomarkers To assess treatment-induced modulation of CA-125 in ovarian cancer Phase 2 To assess additional measures of anticancer activity at the RP2D in patients with advanced solid tumors, as a monotherapy and in combination with carboplatin, fulvestrant, or ribociclib and fulvestrant To assess treatment-induced modulation of CA-125 in ovarian cancer To further characterize the PK profile of BLU-222 monotherapy and in combination with carboplatin, fulvestrant, or ribociclib and fulvestrant and correlate drug exposure with safety assessments and antitumor activity

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    • Protocol Number:
      052305

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital

    • Therapies Involved:
      Chemotherapy single agent systemic Chemotherapy multiple agents systemic

    • Drugs Involved:
      CARBOPLATIN Ribociclib (KISQALI) FULVESTRANT BLU-222

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Advanced solid tumors that has progressed beyond standard of care OR 2. HR+ HER2- BC that has progressed following treatment with a CDK4/6 inhibitor OR 3. Endometrial and gastric cancer that has progressed after at least 2 prior therapies (including one prior platinum therapy) OR 4. Platinum refractory or platinum resistant ovarian cancer CCNE1 amplified tumors that have progressed beyond standard of care

    Exclusion Criteria:

      1. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. 2. Have received the following anticancer therapy: a. Previous therapy with CDK2i, PKMYT1i, or WEE1i, except in Part 1A where up to 10 patients who previously received PKMYT1i, or WEE1 inhibitor will be permitted. 3. Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. 4. Have known intracranial hemorrhage and/or bleeding diatheses. 5. Have clinically active ongoing ILD of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment. 6. Have any unresolved toxicities from prior therapy greater than CTCAE Grade 1 or that have not resolved to baseline at the time of starting the study. 7. Have mean resting QTcF > 450 msec in men or QTcF > 470 msec in women, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome. 8. Have clinically significant, uncontrolled, cardiovascular disease including congestive heart failure Grade III or IV according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months, uncontrolled hypertension, or clinically significant, uncontrolled arrhythmias, including bradyarrhythmia that may cause QT prolongation (eg, Type II second degree heart block or third-degree heart block). 9. Have a history of another primary malignancy other than completely resected carcinomas in situ) that has been diagnosed or required therapy within 2 years prior to initiation of study treatment. 10. Have known active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus (HBV), hepatitis C virus, AIDS-related illness, or COVID-19 infection (symptoms and a positive test result). 11. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration. 12. Have planned major surgical procedure within 14 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures). 13. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions. 14. Patient is a woman who is not postmenopausal or surgically sterile, and is unwilling to abstain from sexual intercourse or employ highly effective contraception OR is a man who is not surgically sterile, and is unwilling to abstain from sexual intercourse or employ highly effective contraception 15. Patient is a pregnant female

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature? Status. - NCT05548296

    Primary Objective: Phase 2 Simon 2-Stage Study (Arm 1 Monotherapy): - Assess the anti-tumor activity of ACR-368 monotherapy in each cohort (ovarian, endometrial, urothelial) of OncoSignature Positive subjects. Phase 1b (Arm 2 Combination Therapy): - Assess the safety and tolerability of ACR-368 in combination with LDG. - Determine the RP2D of LDG. Phase 2 Exploratory Study (Arm 2 Combination Therapy): - Assess the anti-tumor activity of ACR-368 in combination with LDG in each cohort (ovarian, endometrial, urothelial) of OncoSignature Negative subjects.

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    • Protocol Number:
      102302

    • Principal Investigator:
      Aliza Leiser

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      LDG ACR-368

      • Contacts:

      • Rutgers University Prinicipal Investigator: Aliza Leiser

    Read Inclusion & Exclusion Criteria

    Inclusion Criterial: General

      1. Participant must be able to give signed, written informed consent. 2. Participant must have histologically confirmed, locally advanced (i.e., not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen. 3. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria (by local Investigator) (Eisenhauer, 2009). Participant must have radiographic evidence of disease progression based on RECIST criteria following the most recent line of treatment. Biochemical recurrence (eg, CA-125 in ovarian carcinoma) only is not considered as disease progression. 4. Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after signed informed consent. Newly obtained is defined as a specimen obtained up to 6 weeks prior to initiation of treatment on Day 1 if no intercurrent systemic therapy in the interval. 5. Participant must be willing to provide an archival tumor tissue block or at least 20 unstained slides, if available. 6. Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows:
    • Alopecia is accepted.
    • Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need for replacement therapy are accepted (including hypothyroidism, diabetes mellitus, or adrenal insufficiency).
    • Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted. 7. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1. 8. Participant must have an estimated life expectancy of longer than 3 months. 9. Participant must have adequate organ function at Screening, defined as:
    • Absolute neutrophil count > 1500 cells/µL without growth factor support within 1 week prior to obtaining the hematology values at Screening.
    • Hemoglobin ≥ 9.0 g/dL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at Screening.
    • Platelets ≥ 100,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening.
    • Calculated creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft Gault formula.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present.
    • Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable.
    • Serum albumin ≥ 3 g/dL. 10. Participant must have adequate coagulation profile as defined below (including if receiving anticoagulation therapy): Prothrombin time within 1.5 x ULN. Activated partial thromboplastin time within 1.5 x ULN. If the patient is anticoagulated, must be on a stable dose of anticoagulant for ≥ 1 month.

      Tumor Specific Inclusion Criteria

        For Ovarian Carcinoma: 1. Participant must have histologically documented, platinum resistant, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy, is eligible. Platinum sensitive disease, defined as disease which progress after 6 or more months after the completion of platinum-based therapy and primary platinum refractory disease, defined as progression while on the upfront platinum-based therapy, is not eligible. a. Carcinosarcoma is eligible. 2. Participant must have received at least 1 but no more than 6 prior lines of systemic therapy, including at least 1 line of therapy containing platinum derivative and taxane, and single-agent therapy must be appropriate as the next line of treatment: 3. Participant must have had prior bevacizumab or did not receive bevacizumab based on Investigator judgment (see Section 2.1.1). For Endometrial Carcinoma 1. Participant must have histologically documented, high-grade endometrial adenocarcinoma. 1. All Grade 3 International Federation of Gynecology and Obstetrics epithelial endometrial histologies are eligible including: endometrioid, serous, and clear-cell carcinoma. 2. Carcinosarcoma is eligible. Enrollment of participants with this histology will be capped at 5% for each cohort. 3. Participant must have no more than 3 prior lines of therapy in the recurrent setting, including platinum-based chemotherapy for subtypes of endometrial adenocarcinoma where it is a standard of care. 2. Participant must have documented failure or ineligibility (based on Investigator judgement) for prior anti-programmed cell death protein 1/anti-programmed death- ligand 1 (PD 1/PD L1) based therapy for advanced/metastatic disease. Prior combination of PD 1/PD L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor is acceptable. For Urothelial Carcinoma 1. Participant must have histologically documented, advanced (metastatic and/or unresectable) urothelial carcinoma. Variant histology is allowed as long as the tumor is predominantly urothelial. 2. Participants must have: 1. Received a platinum containing regimen (cisplatin or carboplatin) in the metastatic/locally advanced, neoadjuvant, or adjuvant setting. If platinum was administered in the adjuvanteoadjuvant setting, participant must have progressed within 12 months of completion. 2. Failed or have been ineligible for checkpoint inhibitors (including PD-1 or PD-L1 inhibitors). 3. Failed or have been ineligible for enfortumab vedotin. 4. Have no known life-prolonging therapy available

      Exclusion Criteria: General

        1. Participant with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment. 2. Participant had a failure to recover from the reversible effects of prior anti-cancer therapy, as follows: 1. Endocrine events from prior immunotherapy at Grade > 2. 2. Neuropathy events from prior cytotoxic therapies at Grade > 2. 3. All other reversible effects of prior anti- cancer therapy (except alopecia) at Grade >1 or Baseline. 3. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug. 4. Participants has known human immunodeficiency virus, hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2. 5. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis. 6. Participant has cardiovascular disease, defined as: 1. Uncontrolled hypertension defined as blood pressure > 160/90 mmHg at Screening confirmed by repeat (medication permitted). 2. History of torsades de pointes, significant Screening electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT (QTc) > 450 msec (for men) or > 470 msec (for women). 3. Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, transient ischemic attack, or cerebrovascular accident within 6 months of Day 1). 7. Participant has a history of major surgery within 4 weeks of Screening. 8. Participant has a history of bowel obstruction requiring decompression through a nasogastric tube within 8 weeks of Screening. Participants has signs or symptoms of intestinal obstruction, which include nausea, vomiting, and objective radiologic finding of bowel obstruction. 9. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368

      Tumor Specific Exclusion Criteria

        For Ovarian Carcinoma: 1. Participant has non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma. 2. Participant has a history of clinically meaningful ascites, defined as a history of paracentesis or thoracentesis within 4 weeks of Screening. Participant has a planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing. 3. Participant has a history of active inflammatory bowel disease within 2 years prior to Screening. 4. Participant has a history of bowel perforation, fistula, necrosis, or leak within 8 weeks of Screening. For Endometrial Adenocarcinoma: 1. Participant has low-grade endometrioid carcinoma. 2. Participant has mesenchymal tumors of the uterus. 3. Participant has a history of clinically meaningful ascites, defined as a history of paracentesis or thoracentesis within 4 weeks of Screening. Participant has a planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing. For Urothelial Carcinoma: 1. Participant has sarcoma, carcinosarcoma, melanoma, or lymphoma of the bladder. 2. Participant has not received a previous platinum-based regimen. 3. Participant has small cell or neuroendocrine histology.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma - NCT04814108

    Primary Objectives: Cohort 1: - To investigate the antitumor activity of ZN-c3 based on ORR. Cohort 2: - To investigate the antitumor activity of ZN-c3 based on ORR. Combined Cohorts 1 and 2: - To select a dose, 200 or 300 mg of ZN-c3, based on clinical activity and safety. Secondary Objectives: - To further investigate antitumor activity based on ORR, DOR, and PFS. - To investigate OS - To investigate the safety and tolerability of ZN-c3

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    • Protocol Number:
      102104

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Cervix,Other Female Genital,Corpus Uteri

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      ZN-c3

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    INCLUSION CRITERIA 1. Females ≥18 years of age at the time of informed consent. 2. Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject.
    • Subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible.
    • Subjects with carcinosarcomas (even if there is a serous component) are not eligible. 3. Measurable disease per RECIST Guideline Version 1.1 4. Required prior therapy for endometrial cancer: 1. Treatment with a platinum-based chemotherapy regimen. 2. Treatment with a PD-(L)1 inhibitor 3. Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible. 5. Adequate hematologic and organ function EXCLUSION CRITERIA 1. Any of the following treatment interventions within the specified time frame prior to C1D1: 1. Major surgery within 28 days 2. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter). 3. Radiation therapy within 21 days; 4. Autologous or allogeneic stem cell transplant within 3 months. 5. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter). 2. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC. 3. A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2, Open-Label, Randomized, Non-Comparative Clinical Trial of ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in Subjects With Recurrent Ovarian Cancers - NCT05601752

    Primary: To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer Secondary: 1. To evaluate the safety and tolerability of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer 2. To further evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer 3. To characterize the surrogates of treatment effect Biomarker: To evaluate the performance characteristics of the MAGE-A4 clinical trial assay method to a candidate companion diagnostic (CDx) test using retained prescreening tumor tissue from subjects who were tested for trial eligibility Exploratory: 1. To evaluate changes in health-related outcomes following treatment with ADP-A2M4CD8 as monotherapy and in combination with nivolumab 2. To characterize the tumor and tumor microenvironment pre- and post-T-cell infusion to understand tumor-driven determinants of response and resistance to ADP-A2M4CD8 as monotherapy and in combination with nivolumab 3. To characterize subject peripheral blood, which includes, but is not limited to, transduced T-cells (ADP-A2M4CD8), non-transduced T-cells, as well as serum and/or plasma pre- and post-T-cell infusion to understand factors that can influence response or resistance to ADP-A2M4CD8 as monotherapy and in combination with nivolumab

    View All Details
    • Protocol Number:
      102304

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ADP-A2M4CD8

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Subjects will be assessed for eligibility prior to leukapheresis AND prior to lymphodepleting chemotherapy (unless otherwise noted) and must meet all specified criteria for study participation.

      Inclusion Criteria:

        1. Subject (or legally authorized representative) has voluntarily agreed to participate by giving written informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and applicable local regulations. 2. Subject (or legally authorized representative) has agreed to abide by all protocol-required procedures including study related assessments and management by the treating institution for the duration of the study, including LTFU. 3. Subject is ≥ 18 and ≤ 75 years of age at the time the Pre Screening informed consent form (ICF) is signed. 4. Subject has histologically confirmed diagnosis of high-grade serous or high-grade endometrioid recurrent ovarian carcinoma, including primary peritoneal and fallopian tube carcinoma. 5. Subject has measurable disease according to RECIST v1.1 prior to lymphodepletion. Measurable disease is not required prior to leukapheresis. 6. Subject has the following disease-specific prior therapy requirements: 1. The initial therapy must have included at least 3 cycles of a prior platinum and taxane based chemotherapy regimen for primary disease, possibly including intraperitoneal therapy, consolidation, or extended therapy (maintenance/consolidation). 2. Subjects may receive up to 4 prior regimens of combination or single agent systemic treatment for recurrent or metastatic disease, which may include investigational therapies unless discussed and agreed upon with the Sponsor or designee. 3. Subjects who have received only 1 line of platinum based therapy must have progressed between 93 and 183 days of completing platinum based therapy as a part of front line treatment of ovarian cancer. Subjects who have progressed within 92 days of completing platinum based therapy in front line treatment are excluded. 4. Subjects who have received 2 or more lines of platinum based therapy must have progressed during or within 183 days of completing the latest platinum based therapy for treatment of recurrent ovarian cancer. The number of days (platinum-free interval) should be calculated from the date of the last administered dose of platinum therapy to the date of documentation of progression. 5. Subjects with a known BRCA mutation (germ line or somatic) must have received a poly adenosine diphosphate-ribose polymerase (PARP). 6. Subjects must have received bevacizumab. 7. Positive for HLA-A*02:01, HLA-A*02:02, HLA-A*02:03, or HLA-A*02:06 allele as determined by Adaptimmune-designated central laboratory testing. HLA-A*02 alleles having the same protein sequence in the peptide binding domains (P group) will also be included. Other HLA-A*02 alleles may be eligible after adjudication with the Sponsor. 8. MAGE-A4 expression, defined as ≥ 30% of tumor cells that are ≥ 2+ by IHC, should be documented at the pre screening period based on either an archival specimen or a fresh biopsy. All samples must have been pathologically reviewed by an Adaptimmune-designated central laboratory confirming expression. 9. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 10. Subject has left ventricular ejection fraction (LVEF) of ≥ 50% or the institutional lower limit of normal range, whichever is lower. 11. Subject is fit for leukapheresis, and adequate venous access can be established for the cell collection. 12. Subjects of childbearing potential must have a negative urine or serum pregnancy test AND must agree to use a highly effective method of contraception starting at the first dose of chemotherapy and continue for at least 12 months or for 4 months after the gene-modified cells are no longer detected in the blood, or 6 months after the last dose of nivolumab, whichever is longer. Subjects of childbearing potential must also agree to refrain from egg donation, storage, or banking during these same time periods. 13. Subjects must have ≥ 90% room air oxygen saturation test at rest at Screening (within 7 days of leukapheresis) and at Baseline. 14. Subject must have adequate organ function as indicated by the laboratory values in the table below. System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (without granulocyte colony stimulating factor [G-CSF] support) Platelets ≥ 100 × 109/L (without transfusion support within 5 days prior to leukapheresis and lymphodepletion) Hemoglobin (Hb) ≥ 90 g/L (without transfusion support within 5 days prior to leukapheresis and lymphodepletion) Coagulation Prothrombin time or international normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN), unless receiving therapeutic anticoagulation Partial thromboplastin time ≤ 1.5 × ULN, unless receiving therapeutic anticoagulation Renal Glomerular filtration rate (GFR) or creatinine clearance (CrCl) (estimated or calculated)1 ≥ 50 mL/min /1.73 m2 or ≥ 50 mL/min Hepatic Serum total bilirubin ≤ 1.5 × ULN (unless subject has documented Gilbert's Syndrome with direct bilirubin < 35% of total bilirubin) Exception: Subjects with liver metastasis ≤ 2.5 × ULN Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × ULN Exception: Subjects with liver metastasis ≤ 5.0 × ULN 1 Renal function (GFR or CrCl) will be estimated or measured according to standard practice at the treating institution. Renal function will be reassessed at Baseline using the same methodology. Note: Laboratory values that are slightly out of the laboratory test parameters, if assessed as not clinically significant by the site study Investigator, may be acceptable after discussion and review by the Sponsor Study Physician. This applies to screening laboratory assessments and baseline laboratory assessments.

      Exclusion Criteria:

        1. Positive for HLA-A*02:05 in either allele as determined by Adaptimmune-designated central laboratory testing. HLA-A*02 alleles having the same protein sequence as HLA-A*02:05 in the peptide binding domains (P groups) will also be excluded. Other alleles may be exclusionary after adjudication with the Sponsor. 2. Subject has received or plans to receive the following therapy/treatment prior to to leukapheresis or lymphodepleting chemotherapy, unless stopped according to the washout requirements: 3. Toxicity from previous anti-cancer therapy that has not recovered to Grade ≤ 1 or baseline prior to enrollment (except for nonclinically significant toxicities, e.g., alopecia and vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled. 4. Subject has a history of allergic reactions attributed to compounds of similar chemical or biological composition to fludarabine, cyclophosphamide, or other agents used in the study. 5. Subject has an active autoimmune or immune-mediated disease that has not yet been resolved. Subjects with immune-mediated AEs secondary to treatment with immunotherapy that resolve to Grade ≤ 1 off steroids are permitted. Subjects with hypothyroidism, type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy are eligible. Subjects with disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well controlled without requiring systemic immunosuppression are also eligible. Other stable immune conditions that do not require prednisone > 20 mg/day (or its equivalent for other corticosteroid agents) may be acceptable with the agreement of the Sponsor. 6. Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical-related toxicities. Surgical-related toxicities that are not clinically significant per Investigator assessment may be acceptable after discussion and agreement with the Study Physician. 7. Leptomeningeal disease, carcinomatous meningitis, or symptomatic central nervous system (CNS) metastases. Subjects with prior history of symptomatic CNS metastases must have received treatment (i.e., SRS, WBRT, or surgery) and be neurologically stable for at least 1 month, not requiring anti-seizure medications, or off steroids for at least 14 days prior to leukapheresis and lymphodepletion. Subjects who have asymptomatic CNS metastases without associated edema, shift, or requirement for steroids or anti-seizure medications are eligible. If such a subject receives SRS or WBRT, a minimum period of 2 weeks needs to lapse between the therapy and lymphodepletion. Prophylactic anti-seizure medication is allowed. 8. Subject has any other prior malignancy that is not considered by the Investigator to be in complete remission. Resectable squamous or basal cell carcinoma of the skin is acceptable. Prior malignancies that have been surgically resected and show no evidence of disease are acceptable. 9. Clinically significant cardiovascular disease including, but not limited to, any of the following: 1. Electrocardiogram (ECG) showing clinically significant abnormality at Screening 2. Uncontrolled clinically significant arrhythmias 3. Known family history or congenital history of prolonged QT syndrome or history of torsade de pointes 4. Uncontrolled hypertension despite optimal medical therapy 5. Acute coronary syndrome (angina or myocardial infarction) in the last 6 months 6. Clinically significant cardiac disease defined by congestive heart failure New York Heart Association Class 3 and 4 7. History of stroke, CNS bleeding, transient ischemic attack, or reversible ischemic neurologic deficit within last 6 months 10. Uncontrolled intercurrent illness including, but not limited to, any of the following: 1. Ongoing or active systemic infection, or localized infection which may become systemic due to leukapheresis procedure, e.g., catheter insertion will be excluded. Subjects with urinary tract infections will be included only following treatment with antibiotics.(For SARS-CoV 2 [COVID-19] infection, see Section 10.4.4.1) 2. Clinically significant pulmonary disease with any 1 pulmonary function parameter < 60% predicted (forced expiratory volume first forced breath [FEV1], total lung capacity [TLC], or diffusing capacity of lungs for carbon monoxide [DLCO]; note: for patients with anemia, corrected DLCO could be used) assessed prior to leukapheresis and within 2 months of the start of lymphodepleting chemotherapy 3. Requirement for oxygen support (due to cardiac or pulmonary disease) 4. Interstitial lung disease (pneumonitis) or history of pneumonectomy or chronic obstructive pulmonary disease with ≥ 1 exacerbation within 1 year prior to the Screening Visit that required treatment with systemic corticosteroids or resulted in hospitalization 5. Hospitalization for bowel obstruction in last 2 months 6. Hematosis or significant organ bleeding in last 2 months 7. Ascites or pleural effusion which requires repeated (2 within 4 weeks) paracentesis or thoracentesis within last 2 months 8. Cardiac or pericardial tumor involvement (prior to lymphodepletion) 11. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human T cell leukemia virus (HTLV) as defined below. Re-screening for infectious disease markers is not required at baseline (prior to lymphodepletion) unless > 6 months has elapsed. 1. Positive serology for HIV 2. Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Subjects who are hepatitis B surface antigen negative but are hepatitis B core antibody-positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation. Prophylaxis should be initiated prior to lymphodepleting therapy and continued for 6 months. 3. Active hepatitis C infection as demonstrated by hepatitis C ribonucleic acid (RNA) test. Subjects who are HCV antibody-positive will be screened for HCV RNA by any reverse transcription-polymerase chain reaction (RT PCR) or branched DNA (bDNA) assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value. 4. Positive serology for HTLV 1 or 2 12. Subject is pregnant or breastfeeding. 13. Subjects who have illicit drug or alcohol dependency within the past year. 14. In the opinion of the Investigator, subject will be unlikely to fully comply with protocol requirements. 15. Intolerance to nivolumab includes severe allergic reaction to nivolumab or any components (active or inactive) of nivolumab.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors. - NCT03067181

    The aim of this study for low and standard risk germ cell tumor (GCT) patients is to minimize toxicity by reducing therapy while maintaining current survival rates. The trial will eliminate chemotherapy for low risk patients who are likely cured with surgery and will observe the salvage rates among those who recur.

    View All Details
    • Protocol Number:
      111702

    • Principal Investigator:
      Archana Sharma DO

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Ovary,Prostate

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ETOPOSIDE CARBOPLATIN BLEOMYCIN CISPLATIN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Archana Sharma DO

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
    • Standard risk 1: Patient must be < 11 years of age at enrollment
    • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
    • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
    • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
    • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
    • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
    • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
    • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Notes:
    • IGCCC criteria only apply to SR2 patients with a testicular primary tumor
    • Use post-op tumor marker levels to determine IGCCC risk group
    • Stage 1 seminoma patients are not eligible for the standard risk arms of the study
    • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
    • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
    • Adequate renal function defined as:
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR
    • A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): (mg/dL)
    • 1 month to < 6 months male: 0.4 female: 0.4
    • 6 months to < 1 year male: 0.5 female: 0.5
    • 1 to < 2 years male: 0.6 female: 0.6
    • 2 to < 6 years male: 0.8 female: 0.8
    • 6 to < 10 years male: 1 female: 1
    • 10 to < 13 years male: 1.2 female: 1.2
    • 13 to < 16 years: male: 1.5 female: 1.4
    • >= 16 years male: 1.7 female: 1.4
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
    • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment)
    • Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior to enrollment) AND
    • Platelet count >= 100,000/mm^3 (within 7 days prior to enrollment)
    • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
    • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
    • >= 11 and < 25 years old at enrollment
    • Able to fluently speak and read English
    • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
    • Followed for cancer or survivorship care at one of the following institutions:
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • Dana Farber/Harvard Cancer Center
    • Hospital for Sick Children
    • Children's Hospital of Eastern Ontario
    • Oregon Health and Science University
    • Seattle Children's Hospital
    • Yale University

    Exclusion Criteria:

    • Patients with any diagnoses not listed including:
    • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
    • Pure dysgerminoma
    • Pure mature teratoma
    • Pure immature teratoma COG stage I, grade I
    • Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL
    • Pure immature teratoma COG stage II - IV or FIGO stage IC to IV
    • "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or
    • Primary central nervous system (CNS) germ cell tumor
    • Germ cell tumor with somatic malignant transformation
    • Spermatocytic seminoma
    • Patients must have had no prior systemic therapy for the current cancer diagnosis
    • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
    • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers. - NCT05686226

    The primary objective of this trial is to determine the objective tumor response rate (CR+PR) and duration of response for treatment of recurrent/refractory or metastatic HPV-associated cancers with E7 TCR-T cells.

    View All Details
    • Protocol Number:
      192204

    • Principal Investigator:
      Christian Hinrichs

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Other Male Genital,Larynx,Other Female Genital,Cervix,Anus,Lip, Oral Cavity and Pharynx

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      E7 TCR T cell

      • Contacts:

      • Rutgers University Prinicipal Investigator: Christian Hinrichs

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer. 2. Tumor with HPV16 genotype as determined by testing performed in a CLIA certified laboratory. 3. HLA-A*02:01 allele as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis. 4. Measurable disease as assessed by RECIST Criteria Version 1.114. 5. Age ≥ 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening. 7. Must have received prior first line standard therapy or have declined standard therapy. 8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII). 9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery. 10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy tests is not required for women who have had a bilateral oophorectomy or hysterectomy. 11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a women become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 12. Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for Hepatitis C (HCV) RNA must be negative. 13. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/microliter (mcL) 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 8.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum aspartate transferase (AST) (SGOT)/alanine transaminase (ALT) (SGPT) < 2.5 x upper limit of normal (ULN) 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. international normalized ratio (INR) or activated partial thromboplastin time ( aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage. 14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. 15. Participants must be able to understand and be willing to sign the written informed consent document. 16. Participants must agree to participate in protocol Cancer Institute of New Jersey (CINJ) 192103 (Pro2021002307) for gene therapy long term follow up and in protocol CINJ 192002 (Pro2021000281) for biospecimen collection study.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-ZZFX (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma. - NCT05256225

    Primary: Phase II: Progression Free Survival To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed progression free survival (PFS) as assessed by RECIST 1.1. The two experimental arms (Arms 2 and 3) will be compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other. Phase III: Overall Survival To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed overall survival (OS). The two experimental arms (Arms 2 and 3) will be compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other. Secondary: - To evaluate the overall response rate (ORR) in patients with measurable disease. The ORR will be defined as the binomial proportion of evaluable patients with a best overall response of CR or PR (by RECIST 1.1) within 12 months of initiating maintenance therapy. - To evaluate the duration of objective response in patients with measurable disease as assessed by RECIST 1.1. - To determine the nature, frequency and degree of toxicity as assessed by CTCAE v.5.0 for each treatment arm. - To compare QOL, as measured by FACT-En-TOI, in the experimental versus control arms. - To compare patient-reported treatment-associated symptoms (diarrhea and rash) as measured with the PRO -CTCAE, patient-reported fatigue as measured with the PROMIS-Fatigue short form, and worry concerning side effects of treatment as measured by the item bothered by side effect , in the FACT-En TOI, respectively, in the experimental and control arms. - To assess the correlation of HER2 IHC expression and ISH amplification with clinical outcome and response to HER2 targeted therapies. Exploratory Objectives: To explore time to sustained deterioration in quality of life, as measured by a drop in the FACT-En-TOI by 6 or more points lasting for more than one PRO time point, in the experimental and control arms.

    View All Details
    • Protocol Number:
      102301

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CARBOPLATIN TRASTUZUMAB Hyaluronidase-oysk Pertuzumab PACLITAXEL

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IVB, non-recurrent, chemotherapy (chemo)-naive, HER2-positive endometrial serous carcinoma or endometrial carcinosarcoma
    • Histologic confirmation of the original primary tumor is required. Submission of surgical pathology report (or endometrial biopsy pathology report in patients who never undergo hysterectomy) is required
    • Patients must be within 8 weeks of primary surgery (or endometrial biopsy in patients who never undergo hysterectomy) at the time of study registration
    • Patients may have measurable disease, non-measurable disease, or no measurable disease. In patients with measurable disease, lesions will be defined and monitored by RECIST v 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
    • For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium. Any amount of myoinvasion is acceptable for eligibility. Patients with non-invasive disease, endometrial intraepithelial carcinoma alone, or disease confined to a polyp will be excluded
    • Additionally, patients must have the following histologic types to be eligible:
    • Serous adenocarcinoma (may include =< 10% non-serous histology)
    • Carcinosarcoma with serous epithelial component (only the serous component needs to be HER2 positive; may include =< 10% non-serous histology)
    • In cases where determination of serous is equivocal or challenging, aberrant p53 immunohistochemistry (IHC) (defined as overexpression of p53 compared to internal controls) will be sufficient for inclusion
    • All patients must have tumors that are HER2 positive as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 Breast Cancer guidelines (https://documents.cap.org/documents/algorithim-evaluation-her2.pdf. In general HER2 positivity is defined as any of the following:
    • 3+ immunohistochemistry (IHC),
    • 2+ IHC with positive in situ hybridization (ISH)
    • Average HER2 copy number >= 6.0 signals/cell
    • Average HER2 copy number >= 4.0 and < 6.0 signals/cell, with concurrent IHC 3+
    • HER2/CEP17 ratio >= 4.0 signals/cell
    • HER2/CEP 17 ratio >= 2.0 and < 4.0, with concurrent IHC 3+ IHC and ISH testing will be done locally, at each participating institution and interpreted by local pathologists. Alternatively, patients could be eligible if next generation sequencing (NGS) demonstrates HER2 (ERBB2) amplification. NGS testing can be performed through any designated labs as per the National Cancer Institute (NCI) MATCH/NCI Combo-MATCH trial (https://ecog-acrin.orgci-match-eay131-designated-labs). Pathology report showing results of institutional HER2 testing (or NGS testing results) must be submitted. Sites must submit all results available (IHC, ISH, and NGS)
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    • Age >= 18
    • Platelets >= 100,000/mcl (within 14 days prior to registration)
    • Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration)
    • Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) or estimated Glomerular filtration rate (eGFR) >= 50 mL/min using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR). (within 14 days prior to registration)
    • Total serum bilirubin level =< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled) (within 14 days prior to registration)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to registration)
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
    • Although the uterus will have been removed in the vast majority of patients, for patients of child-bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. Patients will be considered of non-reproductive potential if they are either:
    • Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR
    • Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to registration
    • Have a congenital or acquired condition that prevents childbearing
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. NOTE: Patients with prior anthracycline exposure are NOT eligible
    • Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
    • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

    Exclusion Criteria:

    • Prior Therapy:
    • Patients must NOT have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma
    • Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation includes external beam pelvic radiation therapy, external beam extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy
    • NOTE: Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment. Planned use of vaginal brachytherapy must be declared at time of registration
    • Patients may have received prior hormonal therapy for treatment of endometrial carcinoma. All hormonal therapy must be discontinued at least one week prior to registration
    • Patients may not have a planned interval cytoreduction or hysterectomy, prior to documentation of progression, after study registration
    • Patients may not have planned external beam radiotherapy, prior to documentation of progression, after study registration
    • Significant cardiovascular disease including:
    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications
    • Myocardial infarction or unstable angina within 6 months prior to registration
    • New York Heart Association functional classification II, III or IV
    • Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate
    • Significant lung disease: dyspnea at rest grade 2 or greater (resulting from extensive tumor involvement or other causes), pneumonitis grade 2 or greater, interstitial lung disease grade 2 or greater, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)
    • Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), uncontrolled interstitial lung disease, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
    • Treatment with strong CYP2C8 or CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to registration
    • Women who are unwilling to discontinue nursing

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase II/III Trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy. - NCT04628767

    Cisplatin Eligible Patients (Arms A and B) Event Free Survival (EFS): The primary objective of the cisplatin eligible cohort (N=220) is to compare event-free survival (EFS) between patients with UTUC randomized to neoadjuvant aMVAC alone or in combination with MEDI4736 (durvalumab). Cisplatin Ineligible Patients (Arm C) Pathologic Complete Response (pCR) at surgery: The primary objective of the cisplatin ineligible cohort (N=29) is evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pCR, pT0N0/ Nx). Secondary Objectives: Cisplatin Eligible Cohort: To assess pathologic complete response (pCR) at surgery. Cisplatin Ineligible Cohort: Event-free survival (EFS) will be evaluated for the cisplatin ineligible cohort as a secondary endpoint. In all patients: - Overall survival in all, and by post chemotherapy response. - To evaluate disease-free survival (DFS) in each arm separately. - To evaluate cancer-specific survival of patients in each arm separately. - To evaluate renal function outcomes following systemic treatment and following surgery (RNU) in each arm separately. - To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with MEDI4736 (durvalumab) prior to RNU.

    View All Details
    • Protocol Number:
      082210

    • Principal Investigator:
      Saum Ghodoussipour

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital,Other Male Genital,Urinary Bladder

    • Therapies Involved:
      Chemotherapy multiple agents systemic Surgery

    • Drugs Involved:
      aMVAC MEDI4736 (Durvalumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Saum Ghodoussipour

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • STEP 1 REGISTRATION AND RANDOMIZATION
    • Patients must be >= 18 years of age
    • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
    • Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 12 weeks (84 days) prior to registration/randomization with one of the following:
    • Upper urinary tract mass on cross-sectional imaging or
    • Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology
    • NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice
    • Leukocytes >= 3,000/mcL (obtained =< 14 days prior to registration/randomization)
    • Platelets >= 100,000/mcL (obtained =< 14 days prior to registration/randomization)
    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN for patients with Gilbert's disease) (obtained =< 14 days prior to registration/randomization)
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 14 days prior to registration/randomization)
    • Hemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization)
    • NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial
    • NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months
    • NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count >= 250 cells/mcL within 7 days of registration/randomization
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
    • NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
    • Patient must have a body weight of > 30 kg
    • Patient must have life expectancy of >= 12 weeks
    • Patient must have creatinine clearance > 15 ml/min as by Crockroft-Gault formula or 24-hour creatinine clearance within 28 days prior to registration/randomization
    • NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and/or hearing loss in keeping with SOC cisplatin contraindications. Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B
    • Patients that meet any of the following criteria will be registered and assigned to the cisplatin-ineligible Arm C if they meet other eligibility criteria:
    • Creatinine clearance > 15 ml/min and =< 50 ml/min or hearing loss grade >= 3, or neuropathy >= 2, or ECOG PS 2
    • Patient must have an absolute neutrophil count (ANC) >= 1,000/mcL obtained =< 14 days prior to registration
    • Patient must have ECOG performance status 0-2
    • Patients that meet the following criteria will be randomized to the cisplatin-eligible Arm A or Arm B:
    • Patient must have creatinine clearance of > 50ml/min, PS ECOG 0-1, absence of hearing loss grade >= 3, and/or neuropathy >= 2
    • Patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization
    • Patient must have left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization

    Exclusion Criteria:

    • Patients must not have any component of small celleuroendocrine carcinoma. Other variant histologic types are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma
    • Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
    • Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment
    • Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings >=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) or other imaging or other criteria can be eligible based on investigator discretion).
    • NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scans to evaluate for bone metastasis at the discretion of local provider.
    • Patient must meet below criteria for prior/current malignancy history:
    • Non-urothelial cancer malignancy history:
    • Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat
    • NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed
    • Urothelial cancer malignancy history:
    • Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:
    • T0, Ta or Tis at any time
    • T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy [e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)]. Prior immune checkpoint inhibitor is not allowed.
    • Patient with history of >= pT4b, N+, and/or M1 is not eligible.
    • NOTE: Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (< cT1 N0) are eligible regardless of time elapsed
    • Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last three months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements
    • Patient must not have received prior radiation therapy to >= 25% of the bone marrow for other diseases
    • Patient must not have received prior systemic anthracycline therapy
    • NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible
    • Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory bowel disease [IBD], colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible
    • Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion:
    • Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment
    • Steroids as premedications for hypersensitivity reactions (e.g. computed tomography [CT] scan premedication)
    • Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab
    • Patient must not have had a major surgical procedure within 28 days prior to registration/randomization
    • NOTE: Cystoscopy/ureteroscopy, stent placement or nephrostomy tube is not considered major surgery
    • Patient must not have history of allogenic organ transplantation

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors. - NCT02582697

    Primary Objectives: 1. To determine if accelerated BEP (Bleomycin, Etoposide, cisPlatin) is superior to standard BEP as first-line chemotherapy for intermediate and poor-risk metastatic GCTs. 2. To compare the two treatment arms with respect to: a) Progression-free survival (disease progression or death) b) Response following treatment completion (protocol-specific response criteria) c) Adverse events (worst grade according to NCI CTCAE v4.03) d) Delivered dose-intensity of chemotherapy (Relative to standard BEP) e) Overall survival (death from any cause).

    View All Details
    • Protocol Number:
      111904

    • Principal Investigator:
      Scott Moerdler M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Male Genital,Other Female Genital

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ETOPOSIDE IFOSFAMIDE MESNA CISPLATIN Pegfilgrastim

      • Contacts:

      • Rutgers University Prinicipal Investigator: Scott Moerdler M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Age ≥ 11 years and ≤ 45 years on the date of randomisation 2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently 3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum 4. Metastatic disease or non-testicular primary 5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information). 6. Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L 7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN 8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan 9. ECOG Performance Status of 0, 1, 2, or 3 10. Study treatment both planned and able to start within 14 days of randomisation. 11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments 12. Able to provide signed, written informed consent

    Exclusion Criteria:

      1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence) 2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration. Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy. 3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin 4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin 5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus 6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety 7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy. 8. Known allergy or hypersensitivity to any of the study drugs 9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
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