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  • A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma - NCT02954094

    Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC

    View All Details
    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

      • Contacts:

      • Archived - Rutgers Robert Wood Johnson Medical School Prinicipal Investigator: Vinod Rustgi MD, MBA

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

    Exclusion Criteria:

      1. Inability to provide written informed consent

    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 Digital Intervention to Improve Skin Self-Examination Among Melanoma Survivors. - NCT05373823

    Aim 1. To enhance MSS by collaborating with multi-level stakeholders. We will collaborate with stakeholders in enhancing MSS through qualitative interviews and usability testing of potential enhancements. Enhancements are based on empirically validated behavior change techniques (BCTs) and our prior study. We will utilize an iterative process that includes: (1) key informant interviews with survivors, providers, and professional organizations regarding proposed enhancements; (2) conversion to an enhanced mobile-based delivery platform; (3) usability testing, and; (4) iterative program refinements. Aim 2. To evaluate the effects of enhanced MSS on thorough SSE in an RCT and examine its impact on the diagnosis of new/recurrent melanomas (N= 300). We will conduct a RCT comparing MSS and a non-interactive educational webpage with 300 survivors to test its effects on SSE. We propose that MSS participants will be more likely to perform thorough SSE over the 18-month follow-up. We will explore the impact of MSS on new/recurrent melanomas. We propose that there will be more earlier stage melanomas diagnosed in MSS as compared with UC. Aim 3. To assess selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation. We will use mixed methods to assess implementation outcomes and explore perspectives from survivors, care providers, and professional organizations about how to best disseminate and implement MSS on a broad scale. The sub-aims are: 3a) To estimate program costs and assess cost-effectiveness of MSS relative to control. We hypothesize that MSS costs will be higher than UC. We expect that MSS will be a more cost-effective strategy, given its greater effectiveness to increase SSE and identify new or recurrent melanoma. If our findings support this as expected, exploratory cost-effectiveness analyses from the health care and societal perspectives will be conducted using simulation models of melanoma-related costs, disease progression, and survival over 5- and 10-year analysis horizons. 3b) To examine MSS reach, adoption, engagement, acceptability, appropriateness, feasibility, and maintenance. For reach, we predict that demographic variables will not differ from the general population of melanoma survivors. For adoption, we propose that the proportion of contacted/eligible survivors randomized to MSS who consent, complete the baseline, and log into MSS will be equal or greater than the efficacy trial. For engagement, we propose that 80% of MSS participants will log in. For acceptability, we predict MSS will be rated as highly acceptable. 3c) To identify and describe contextual factors from multilevel stakeholders as key to scale-up and widespread implementation of MSS, including consideration of potential delivery settings, timing of delivery, and needed resources to promote its implementation and sustainability.

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    • Protocol Number:
      132202

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
    • Three months to five years post-surgery
    • No current evidence of cancer
    • Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
    • ≥ 18 years old
    • Internet access
    • Able to speak/read English
    • Able to provide informed consent

    Exclusion Criteria:

    • Children

    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 Dose Finding Study of CycloSam? (153Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewings Sarcoma, and other solid tumor(s) to the bone all eligible). - NCT06008483

    The primary objective of this study is: To determine the MTD of CycloSam?, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan. The secondary objectives of this study are: 1. To describe the toxicity and long-term effects of infusional CycloSam?; 2. To assess the clinical response of solid tumors to the bone or metastatic to the bone to therapy with infusional CylcoSam?; 3. To describe the distribution of absorbed doses delivered to each targeted lesion and the distribution of lesion equivalent uniform dose delivered to each subject; 4. To observe overall survival and time to progression in subjects treated with infusional CycloSam?, and model any relationship between total absorbed dose and progression; 5. To assess the extent of pain palliation using a visual analogue scale (VAS) in subjects treated with infusional CycloSam?.

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    • Protocol Number:
      052201

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast,Prostate,Lung,Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CycloSam (153Sm-DOTMP)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Subjects will be between the ages of 15 and 75, inclusive. 2. Subjects must have a histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of a solid tumor to the bone or metastatic to the bone. 3. Subjects must have measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan. Not all lesions must be positive on bone scan. 4. Adequate organ function, including: i. Adequate renal function, defined as a measured creatinine clearance >70 mL/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR). ii. Adequate hematologic function, defined as a platelet count >100,000 cells/mm3 and an absolute neutrophil count (ANC) >1,000 cells/mm3. 5. Life expectancy of at least eight weeks. 6. Karnofsky performance status >50%. 7. Subjects must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to CTCAE v5.0 grade ≤1. Subjects with Grade 2 anemia per CTCAE v5.0 will be permitted as long as the subject has normal cardiac function. 8. Adequate cardiac function. Subjects with previously identified cardiac disease will be eligible, as 153Sm-DOTMP is not expected to cause cardiac dysfunction and is only expected to result in very transient hypocalcemia. 9. A stem cell product collected either by peripheral stem cell mobilization or bone marrow harvest prior to the infusion of CycloSam® must be available, prior to trial entry. A minimum of 2 x 106 CD34+ cells/kg ideal body weight are required. 10. Female subjects of child-bearing potential (defined as premenopausal and capable of becoming pregnant) must have a negative serum pregnancy test at the Screening visit. Females must be surgically sterile, postmenopausal for at least one year prior to Screening (no other medical cause involved) with a Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL or must be using a highly effective method of birth control and agree to its use for at least 30 days following the last dose of 153Sm-DOTMP. Highly effective methods of contraceptive are defined as tubal ligation or an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings, or hormonally-impregnated intrauterine device. 11. Male subjects with partners of child-bearing potential must agree to use highly effective methods of contraception for at least 90 days after the last dose of 153Sm-DOTMP. 12. The subject and/or the subject's legally authorized guardian, if the subject is a minor, must acknowledge in writing that informed consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services. 13. Subjects must have previously received effective treatment for their underlying disease and have no potentially curative options available. 14. The concurrent use of hormonal therapies or bisphosphonates is acceptable, provided the latter do not render target lesions invisible on 99mTc bone scan. Subjects will have the option to re-screen up to once more after seven days if they do not initially meet all of the inclusion criteria

    Exclusion Criteria:

      1. Subject is pregnant or breastfeeding. 2. Subject is sexually active and does not agree to use accepted, effective forms of contraceptive. 3. Subject has received prior radiotherapy to all known areas of current active disease. 4. Subject has a body mass index (BMI) > 50 kg/m2.

    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 Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors. - NCT04925284

    Dose-Escalation Stage (Single-Agent and Combination Therapy Cohorts): Primary Objectives: To determine the MTD and/or RD for further evaluation of intravenous (IV) administration of XB002 alone and in combination therapy in subjects with advanced malignancies Additional Objectives: - To establish the preliminary safety and tolerability profile of XB002 when administered alone and in combination therapy - To evaluate the PK of XB002 (antibody conjugated to payload), total antibody (unconjugated and conjugated antibody), and free payload following IV administration alone and in combination therapy - To assess the immunogenicity of XB002 - To evaluate the anti-tumor activity of XB002 alone and in combination therapy as measured by objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS) per RECIST 1.1 as assessed by the Investigator Exploratory Objectives: - To evaluate the relationship between PK and exploratory biomarkers, preliminary efficacy, and safety outcomes Cohort-Expansion Stage (Single-Agent and Combination Therapy Cohorts): Primary Objective: To evaluate the preliminary efficacy of XB002 when administered alone and in combination therapy by estimating the ORR per RECIST 1.1 as assessed by the Investigator Additional Objectives: - To evaluate the safety and tolerability of XB002 when administered alone and in combination therapy - To further evaluate the PK of XB002 (antibody conjugated to payload), total antibody (unconjugated and conjugated antibody), and free payload following IV administration alone and in combination therapy - To assess the immunogenicity of XB002 - To evaluate the anti-tumor activity of XB002 alone and in combination therapy as measured by DOR and PFS per RECIST 1.1 as assessed by the Investigator - To evaluate the anti-tumor activity of XB002 alone and in combination therapy as measured by ORR, DOR, and PFS per RECIST 1.1 as assessed by a Blinded Independent Radiology Committee (BIRC) for selected cohorts - To evaluate overall survival - To evaluate changes in tumor markers from baseline for selected tumor indications Exploratory Objectives: - To assess the effects of XB002 on tumor and blood biomarkers - To evaluate the exposure of nivolumab in combination with XB002 - To assess the immunogenicity of nivolumab in combination with XB002

    View All Details
    • Protocol Number:
      052215

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      XB002

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.
    • Dose-Escalation Stage Cohorts A and AN: The subject has received atleast one systemic standard life-prolonging therapy unless it does not exist, or available therapies are intolerable or no longer effective.
    • Cohort-Expansion Stage (Cohorts B - M, BN, FN and HN): The subject has received standard life-prolonging therapies unless they do not exist, or available therapies are intolerable or no longer effective.
    • Cohort-Expansion Stage Cohort B and BN (Non-small Cell Lung Cancer): Subjects with Stage IV NSCLC who have documented radiographic disease progression during or following their last systemic anticancer therapy.
    • Cohort-Expansion Stage Cohort D (Epithelial Ovarian Cancer): Subjects with high-grade serous ovarian cancer, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) who have platinum-resistant disease following treatment with platinum-containing chemotherapy.
    • Cohort-Expansion Stage Cohort E (Cervical Cancer): Subjects with persistent, recurrent, or metastatic carcinoma of the uterine cervix who have documented radiographic disease progression during or following their last systemic anticancer therapy.
    • Cohorts F and FN (SCCHN): Subjects with head and neck cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. Allowed primary tumor locations are oral cavity, oropharynx, hypopharynx, glottic larynx. Note: Excluded are subjects with primary tumor site of the nasopharynx.
    • Cohort G (Pancreatic Cancer): Subjects with pancreatic cancer (adenocarcinoma histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy.
    • Cohorts H and HN (Esophageal SCC): Subjects with esophageal cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. Note: subjects with esophageal adenocarcinoma and adenocarcinoma of gastroesophageal junction (GEJ) are excluded.
    • Cohort I (mCRPC): Subjects with metastatic, castration resistant adenocarcinoma of the prostate. Note: Neuroendocrine differentiation and other histological features are permitted if adenocarcinoma is the primary histology.
    • Cohort J (TNBC): Subjects with triple-negative (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/ human epidermal growth factor receptor 2 negative [HER-2-]) breast cancer who have documented radiographic disease progression during or following their last systemic anticancer therapy for inoperable locally advanced or metastatic disease.
    • Cohort K (HR + BC): Subjects with breast cancer that is hormone receptor-positive (ER+ and/or PR+) and HER-2-) and who have documented radiographic disease progression during or following their last systemic anticancer therapy for inoperable locally advanced or metastatic disease.
    • Cohort L (Endometrial Cancer): Subjects with locally advanced, recurrent or metastatic endometrial cancer who have documented radiographic disease progression during or following their last systemic anticancer therapy.
    • Cohort M (Tumor-Agnostic Tissue Factor-Expressing Solid Tumors): Subjects with solid tumors other than those designated in Cohorts B-L and those which express tissue factor. Participation in this cohort will be at selected sites and countries based on site feasibility assessment.
    • Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1 as determined by the Investigator, except for subjects with prostate cancer without soft tissue disease and subjects with primary brain tumors.
    • Tumor tissue material collected no more than 3 years prior to consent, if possible. If archival tumor tissue is not available, a fresh tumor biopsy may be collected from subjects enrolled in the Dose-Escalation Stage and should be collected from subjects in the Cohort-Expansion Stage.
    • Recovery to baseline or ≤ Grade 1 severity (Common Terminology Criteria for Adverse Events version 5 [CTCAE v5]) from AEs.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
    • Adequate organ and marrow function.
    • Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
    • Female subjects of childbearing potential must not be pregnant at screening.

    Exclusion Criteria:

    • Receipt of prior therapies as defined in study protocol
    • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
    • Uncontrolled, significant intercurrent or recent illness.
    • Major surgery within 4 weeks before first dose of study treatment
    • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG).
    • Pregnant or lactating females
    • Previously identified allergy or hypersensitivity to components of study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies.
    • Another unresolved malignancy or a malignancy that is considered to be cured within 2 years before first dose of study treatment. Note: Subjects with superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy within 2 years before first dose of study treatment are eligible.

    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 Double-Blinded, Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib. - NCT04457596

    Primary Objective: To determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. Secondary Objectives: 1. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: - overall survival (OS) - breast cancer free survival (BCFS) - distant recurrence-free survival (DRFS) - disease-free survival (DFS) - brain metastases-free survival (BMFS). 2. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.

    View All Details
    • Protocol Number:
      042106

    • Principal Investigator:
      Coral Omene MD, PhD

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ado-trastuzumab/T-DM1 Tucatinib/Placebo

      • Contacts:

      • Rutgers University Prinicipal Investigator: Coral Omene MD, PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required * Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR
    • Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible)
    • Patients with residual HR-negative, HER2 positive (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for these patients
    • Patients with weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report
    • The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis * Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not
    • Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive
    • Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable
    • Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
    • Prior treatment must have consisted of >= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of >= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration [FDA]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received >= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed.
    • Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a [trastuzumab deruxtecan]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib).
    • Patients may have received =< 1 cycles of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =< 5 weeks prior to registration * Note: Both of the following two criteria need to be met for the patient to be eligible for this study
    • An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment
    • Patients must be registered on study within =< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery)
    • All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response [pCR]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of >= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants
    • Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia and peripheral neuropathy =< grade 1
    • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
    • Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision
    • For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
    • Lymph node surgery ** The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative, no further axillary treatment is necessary. If patients have isolated tumor cells (ITCs) in the setting of residual breast disease, at least one of the following is required: axillary lymph node dissection (ALND) or planned nodal irradiation. If patients have micro- or macro-metastatic nodal disease, ALND and planned nodal irradiation are required. Of note, co-enrollment on Alliance A011202 is not allowed
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Absolute neutrophil count (ANC) >= 1,000/mm^3
    • Hemoglobin >= 8 g/dL (Note: packed red blood cells [PRBC] transfusion is not permitted to achieve eligibility)
    • Platelet count >= 100,000/mm^3
    • Creatinine =< 1.5 x upper limit of normal (ULN)
    • Total bilirubin =< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
    • Screening left ventricular ejection fraction (LVEF) >= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility

    Exclusion Criteria:

    • No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
    • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required
    • Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met
    • Stage IV (metastatic) breast cancer
    • History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
    • Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
    • Evidence of recurrent disease following preoperative therapy and surgery
    • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation)
    • History of exposure to the following cumulative doses of anthracyclines: doxorubicin > 240 mg/m^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) > 480 mg/m^2. For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
    • Cardiopulmonary dysfunction as defined by any of the following:
    • History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade >= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class >= II
    • Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
    • High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 [Mobitz 2] or third degree AV-block)
    • Significant symptoms (grade >= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy
    • History of a decrease in left ventricular ejection fraction (LVEF) to < 40% with prior trastuzumab treatment (e.g., during preoperative therapy)
    • Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
    • Current severe, uncontrolled systemic disease
    • Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment
    • History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
    • Peripheral neuropathy of any etiology that exceeds grade 1
    • Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
    • Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited.
    • Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded.

    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.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Long-Term Study for Participants Previously Treated With Ciltacabtagene Autoleucel. - NCT05201781

    To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.

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    • Protocol Number:
      012204

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Matthew Matasar

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
    • Participants who have provided informed consent for this 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 Multi-Level Investigation of US Indoor Tanning Policy Enactment, Implementation, Compliance, Impact, and Economics.

    1. Identify factors contributing to adoption or rejection of indoor tanning legislation through document analysis of indoor tanning bills and key informant interviews. 2. Assess indoor tanning law implementation. 3. Investigate important economic factors relevant to Indoor tanning law maintenance.

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    • Protocol Number:
      132005

    • Principal Investigator:
      Carolyn Heckman Ph.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Carolyn Heckman Ph.D.
    • Rutgers Cancer Institute of New Jersey
  • A Multicenter, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy. - NCT05239728

    Primary Objective: To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS. Secondary Objectives: - To compare overall survival (OS) for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (2): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to OS. - To compare the safety and tolerability profiles for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. - To compare measures of disease recurrence-specific survival (DRSS) as assessed by the investigator, in participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. - To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 30 Questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-related Symptoms (FKSI-DRS).

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    • Protocol Number:
      082106

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Belzutifan (MK-6482)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D

    Read Inclusion & Exclusion Criteria

    The main inclusion and exclusion criteria include but are not limited to the following:

    Inclusion Criteria:

    • Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
    • Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0 3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
    • Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
    • Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
    • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
    • Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
    • Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
    • Has adequate organ function

    Exclusion Criteria:

    • Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
    • Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
    • Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
    • Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
    • Has preexisting brain or bone metastatic lesions
    • Has received prior systemic therapy for RCC
    • Has received prior radiotherapy for RCC
    • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
    • Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
    • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
    • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    • Has an active infection, requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
    • Has had an allogenic tissue/solid organ transplant

    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 Multicenter, Open Label, Phase III Extension Trial to Study the Long-Term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial. - NCT03486873

    Primary Objective: To estimate the OS. Secondary Objectives: - To estimate the DOR and DOCR per evaluation criteria used in the parent trial by investigator assessment for participants who have received or are receiving First Course Phase trial treatment with pembrolizumab or a pembrolizumabbased combination. - To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase trial treatment.

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    • Protocol Number:
      051804

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
    • Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase. Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
    • Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Demonstrates adequate organ function.
    • Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
    • A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity. Additional eligibility criteria for participants who enter dosing with Lenvatinib:
    • Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications.
    • For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
    • Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.

    Exclusion Criteria:

    • There are no exclusion criteria to participate in MK-3475-587. Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
    • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
    • Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.
    • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
    • Has known active central nervous system metastases and/or carcinomatous meningitis.
    • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
    • Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
    • Has an active infection requiring systemic therapy.
    • Has a known history of human immunodeficiency virus (HIV) infection.
    • Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
    • Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
    • Has hepatic decompensation (Child-Pugh score >6 [class B and C]).
    • Has uncontrolled thyroid dysfunction.
    • Has uncontrolled diabetes mellitus.
    • Has had an allogeneic tissue/solid organ transplant.
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis). Additional exclusion criteria for participants who enter dosing with Lenvatinib:
    • Has had major surgery within 3 weeks prior to first dose of study intervention(s).
    • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
    • Has urine protein ≥1 g/24 hours.
    • Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
    • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
    • Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to >480 ms.
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
    • Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
    • Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
    • Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.

    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 Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) with Pembrolizumab (MK-3475) in Selected Solid Tumors. - NCT06036836

    Primary: Cohort A: To evaluate pathological complete response (pCR) rate of MK- 4280A or pembrolizumab as assessed by blinded central pathology review Cohort B: To evaluate lenvatinib in combination with MK-4280A or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator

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    • Protocol Number:
      102310

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Favezelimab (MK4280A) Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

      Cohort A only
    • Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
    • Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
    • Is systemic treatment naïve
    • Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
    • Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent Cohort B only
    • Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
    • Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
    • Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
    • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
    • Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
    • Has adequately controlled blood pressure without antihypertensive medication All Cohorts
    • Agrees to follow contraception guidelines if a participant of childbearing potential
    • Has a life expectancy >3 years per investigator assessment
    • Has adequate organ function
    • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
    • If positive for hepatitis C, has undetectable viral load at screening
    • If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy

    Exclusion Criteria:

      All Cohorts
    • Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
    • History of allogeneic tissue/solid organ transplant Cohort A only
    • Received prior radiotherapy to the index lesion (in-field lesion)
    • Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible Cohort B
    • Has had major surgery within 3 weeks prior to first dose of study interventions
    • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
    • Has urine protein ≥1 g/24 hours
    • Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
    • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention

    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.

    • Community Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • 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 Open-Label, Multicenter, Phase1a Study of AN2025 and AN0025 in Double Combination with Atezolizumab and in Triple Combination with Atezolizumab in Patients with Advanced Solid Tumors. - NCT04975958

    Primary Objective: To determine the safety and tolerability of the double combinations AN2025 + Atezolizumab (Dose Limiting Toxicity [DLT] Observation I), AN0025 + Atezolizumab (DLT Observation II) and the triple combination AN2025 + AN0025 + Atezolizumab (DLT Observation III) in patients with locally advanced or metastatic cancer that were previously treated with 1-3 lines of therapy. Secondary Objectives: 1. To evaluate the preliminary efficacy of AN2025 and AN0025 in double and triple combinations with Atezolizumab as assessed by: - Overall Response Rate (ORR) and Progression-Free Survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 2. Duration of Response (DOR) 3. Overall Survival (OS); Efficacy by Phosphatidylinositol-4,5-bisphosphate 3 Kinase Catalytic Subunit Alpha (PIK3CA) mutation in DLT Observations I and III. Exploratory Objectives: 1. To assess the preliminary anti-tumor activity by modified RECIST 1.1 for immune-based therapeutics (iRECIST). 2. To assess the immune cell populations in the tumor infiltrate and correlate with the anti-tumor activity of AN2025 and AN0025 in combination treatments with Atezolizumab. 3. To explore the pharmacodynamic effect of AN2025 and AN0025 on selected immune cell populations and selected biomarkers in blood and tumor biopsies. 4. To characterize the pharmacokinetics (PK) of AN2025 and AN0025 in combination treatments with Atezolizumab and explore the potential exposure/response relationship with selected pharmacodynamic biomarkers as appropriate. 5. Efficacy by programmed death receptor-ligand 1 (PD-L1) expression.

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    • Protocol Number:
      052102

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      AN0025(E7046) Atezolizumab (MPDL3280A) Buparlisib (AN2025)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Age ≥18 years at the time of informed consent and have provided signed informed consent for the trial. 2. Willing and able to comply with all aspects of the protocol. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Life expectancy ≥3 months. 5. Diagnosed with histologically confirmed locally advanced and nonresectable, or metastatic disease. 6. Have received at least one line of prior systemic therapy or no alternative therapy to prolong survival exists. 7. Have received no more than 4 prior lines of systemic therapy for advanced disease. Prior therapy in an adjuvant or neoadjuvant setting is not considered as a prior line of systemic therapy. 8. Have measurable disease per RECIST 1.1 as assessed by the local site investigator and/or radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 9. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. If previously treated with anti-PD-1/PD-L1 therapy, tumor tissue sample obtained following the most recent anti-PD-1/PD-L1 therapy is required. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. 10. Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan. 11. Patient has organ function as shown by the following: 1. Absolute neutrophil count (ANC) ≥1.5 x 109/L. 2. Hemoglobin ≥9 g/dL (which may be reached by transfusion 2 weeks prior to the start of the study treatment). 3. Platelets ≥100 x 109/L (which may be reached by transfusion). 4. International normalized ratio (INR) ≤1.5. 5. Calcium (corrected for serum albumin) within normal limits (WNL) or ≤ grade 1 severity according to NCI-CTCAE version 5.0 if judged clinically not significant by the Investigator. Patients concomitantly taking bisphosphonates or denosumab for calcium correction are eligible. (only applicable to Observations I and III) 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x upper limit of normal (ULN) or <5.0 x ULN if liver metastases are present. 7. Total serum bilirubin ≤ ULN or ≤1.5 x ULN if liver metastases are present; or total bilirubin ≤3.0 x ULN with direct bilirubin below or within normal range in patients with well documented Gilbert's Syndrome. Gilbert's syndrome is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from cells blood count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis. 8. Serum creatinine ≤1.5 x ULN or calculated or directly measured creatinine clearance (CrCL) >30 mL/min. 9. HbA1c ≤8%. (Only applicable to Observations I and III) 12. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to Screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, is she considered not of child-bearing potential. 2. Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 5 months after the last dose of Atezolizumab. Highly effective contraception is defined as either:
    • Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
    • Female sterilization: When the female study patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
    • Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient.
    • Using a combination of any two of the following:
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS), and
    • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
    • Hormonal contraception methods (e.g., oral, injected, implanted). 13. A male participant must agree to use contraception during the treatment period and for at least 5 months after the last dose of Atezolizumab.

    Exclusion Criteria:

      1. Have been discontinued treatment due to a Grade 3 or higher immune-related AE (irAE) from prior anti-PD-1or anti-PD-L1, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137). 2. Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter. Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia may be eligible. 3. Have received prior palliative radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease. 4. Severe, uncontrolled tumor-related pain. 5. Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non live COVID vaccinations or boosters should not occur during Cycle 1 or within 30 days prior to the first dose of study drug. 6. Are currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks after the last dose of the previous investigational agent (see Number 2 above). 7. Have had an allogenic tissue/solid organ transplant. 8. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. 9. With a history of another primary malignancy within the past 2 years, with the exception of basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy. 10. Have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 11. Have known severe hypersensitivity to study treatment components. 12. Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis. 13. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis. 14. Have an active infection requiring systemic therapy within 2 weeks prior to Day 1 of Cycle 1. 15. Participants with known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay. 16. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation). 17. Major surgery within 4 weeks before the first dose of study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and/or complications requiring the intervention prior to starting study treatment. 18. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the oral bioavailability of the investigational drugs. 19. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 20. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study, e.g. history of or active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, or history of suicidal attempt or ideation, homicidal ideation (e.g., risk of doing harm to self or others), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM V]) are not eligible. Note: For patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous six weeks prior to start of study drug. 21. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 5 months after the last dose of Atezolizumab. 22. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month. 23. Leptomeningeal disease. 24. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1. 25. Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1 for an active infection (prophylactic antibiotic dosing that is deemed to be essential by the investigator is allowed). 26. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 27. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation. 28. Active tuberculosis. 29. Patient has received previous treatment with any protein kinase B (PKB/AKT), mammalian target of rapamycin (mTOR) inhibitors, or phosphatidylinositol 3 kinase (PI3K) pathway inhibitors (only applicable to Observations I and III). 30. Patient has grade ≥2 neuropathy, colitis, pneumonitis, elevated HbA1C, and uncontrolled endocrinopathies (e.g., hypothyroidism) from previous treatment (only applicable to Observations I and III). 31. Have clinically manifest diabetes mellitus (DM) (treated and/or with clinical signs) that is not well controlled (only applicable to Observations I and III). 32. Patient is currently receiving warfarin or other coumarin-derived anti-coagulant, or anti-Xa agents, for treatment, prophylaxis, or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), fondaparinux or novel oral anticoagulants (NOACs) is allowed. 33. Have diarrhea ≥2 CTCAE Grade 2 (only applicable to Observations I and III). 34. Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A4, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (only applicable to Observations I and III). UGT inducers or inhibitors such as atazanavir, probenecid, valproic acid, mefenamic acid, quinidine (only applicable to Observation II). 35. Patient has a history of non-compliance to any medical regimen or inability to grant consent. 36. Patient that is currently receiving NSAIDs. 37. Patient that is currently receiving angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs): Patients on these hypertensives at study entry should be switched to other hypertensives prior to study drug dosing.

    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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