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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
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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.
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A Basket Trial of Pembrolizumab in Patients with Advanced Solid Tumors and Genomic Instability.
- NCT03428802
To evaluate the response rate of pembrolizumab in patients with evidence of genomic instability classified as follows: 1) All solid tumors with POLE and POLD1 mutations 2) All solid tumors with BRCA1/2 mutations
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Protocol Number:
051709
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Principal Investigator:
Eugenia Girda Assistant
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Phase:
Phase II
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Scope:
Local
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Immunotherapy
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Drugs Involved:
Pembrolizumab (MK-3475)
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Contacts:
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Rutgers University
Prinicipal Investigator:
Eugenia Girda Assistant Professor GYN
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Be willing and able to provide written informed consent/assent for the trial
- Have a diagnosis of a tumor with evidence of genomic instability on Clinical Laboratory Improvement Amendments (CLIA) certified genomic testing, inclusive of mutations in POLE, POLD1 for arm 1 and in BRCA1 and BRCA2 for arm 2; in arm 2, enrollment of breast and ovarian histologies will be limited to a total of 10 patients
- Have advanced cancer (metastatic, recurrent or locally advanced) and measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Be willing to provide archived tumor tissue; tissue from the most obtained core or excisional biopsy of a tumor lesion is preferred; 20 unstained slides are preferred but a minimum of 15 slides will be acceptable; if adequate tissue is not present the patient may consent to a newly obtained biopsy
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- Absolute neutrophil count (ANC) >= 1,500 /mcL, performed within 10 days of treatment
- Platelets >= 100,000 / mcL, performed within 10 days of treatment
- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment), performed within 10 days of treatment
- Serum creatinine =< 1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]), performed within 10 days of treatment
- Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, performed within 10 days of treatment
- Albumin >= 2.5 mg/dL, performed within 10 days of treatment
- International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment
- Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
- Male subjects should agree to abstinence or use of an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
Exclusion Criteria:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
- Has a diagnosis of immunodeficiency that requires receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or has resulted in life threatening episodes previously regardless of current treatment
- Has a known history of active TB (Bacillus tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
- Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, or malignancies that have been inactive for three years or exceptionally indolent; any current diagnosis of second malignancy requires approval from principal investigator and sponsor
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 30 days prior to trial treatment; patients who had oligometastatic disease treated with stereotactic radiation or gamma knife therapy may receive treatment 14 days after therapy as long as they are not requiring steroids; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
- Has 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, etc.) is not considered a form of systemic treatment
- Has known history of, or any evidence of active, non-infectious pneumonitis
- Has an active infection requiring systemic therapy
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- Has received a live vaccine within 30 days of planned start of study therapy
- Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
- Tumors harboring non-hotspot POLE or POLD1 mutations that show clear evidence of microsatellite instability (MSI) will be excluded
- Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
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.
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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).
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
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Principal Investigator:
Sanjay Goel
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Breast,Prostate,Lung,Any Site
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
CycloSam (153Sm-DOTMP)
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Contacts:
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Rutgers University
Prinicipal Investigator:
Sanjay Goel
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A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors .
- NCT03845166
The primary objective is:
Determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for further
evaluation of XL092 when administered alone and in combination with ICIs to subjects with
advanced solid tumors.
The secondary objectives are:
1. Evaluate the safety of XL092 when administered alone and in combination with ICIs through
the evaluation of incidence and severity of non serious adverse events (AEs) and serious
adverse events (SAEs), including immune-related adverse events (irAEs), and adverse events
of special interest (AESIs).
2. Evaluate the plasma pharmacokinetics (PK) of XL092 and it potential metabolites following
XL092 administration alone and in combination with ICI.
The exploratory objectives are:
1. ORR as assessed by the Investigator per RECIST 1.1
2. Investigate the relationship between PK and selected or exploratory biomarkers, preliminary
efficacy, and safety outcomes.
View All Details
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Protocol Number:
052209
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Principal Investigator:
Sanjay Goel
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Chemotherapy single agent systemic
Chemotherapy multiple agents systemic
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Drugs Involved:
Avelumab
XL092
Atezolizumab (MPDL3280A)
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Contacts:
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Rutgers University
Prinicipal Investigator:
Sanjay Goel
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Cytologically or histologically confirmed solid tumor that is inoperable locally advanced, metastatic, or recurrent.
- Dose-escalation (single-agent and combination therapy): Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.
- Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
- Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
- Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
- Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
- Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standard of care chemotherapy regimens as prior therapy for metastatic CRC:
- Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF monoclonal antibody (bevacizumab)
- Anti-EGFR monoclonal antibody (cetuximab or panitumumab)
- BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations
- Expansion Cohort I (UC, Maintenance Therapy): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who received first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin.
- Expansion Cohort J (UC, ICI-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after PD-1/PD-L1 targeting ICI therapy.
- Expansion Cohort K (UC, platinum-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after first-line platinum-based combination therapy.
- Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1, with exception of Cohort I (UC, Maintenance Therapy).
- Tumor tissue material:
- Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained.
- Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- 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 highly effective methods of contraception.
- Female subjects of childbearing potential must not be pregnant at screening.
Exclusion Criteria:
- Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, H, I, and K only), prior treatment with avelumab (Cohort J only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only).
- Receipt of any type of small molecule kinase inhibitor within 2 weeks before first dose of study treatment.
- Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before first dose of study treatment.
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
- 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.
- Concomitant use of certain medications.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 450 ms for males and > 470 ms for females. Single ECGs are no longer permitted.
- Pregnant or lactating females.
- Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
Additional Exclusion Criteria for XL092 + Atezolizumab Combination Therapy Cohorts ONLY:
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
- Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
Additional Exclusion Criteria for XL092 + Avelumab Combination Therapy Cohorts ONLY:
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
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.
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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
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Protocol Number:
042106
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Principal Investigator:
Coral Omene MD, PhD
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Phase:
Phase II/III
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Scope:
National
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Applicable Disease Sites:
Breast
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
ado-trastuzumab/T-DM1
Tucatinib/Placebo
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Contacts:
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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.
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A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors.
- NCT05052268
(Phase 1: Part 1a and Part 1b)
Primary Objectives:
1. To evaluate the safety and tolerability of XTX202 monotherapy in patients with advanced solid tumors.
2. To determine the RP2D and schedule of XTX202 monotherapy.
Secondary Objectives:
1. To characterize the PK profile of XTX202.
2. To evaluate the immunogenicity of XTX202.
3. To evaluate the preliminary antitumor activity of XTX202 monotherapy in patients with advanced solid tumors.
Exploratory Objective:
To evaluate the pharmacodynamic (PD) profile of XTX202 in patients with advanced solid tumors.
Objectives (Phase 2):
Primary Objectives:
1. To evaluate the efficacy of XTX202 monotherapy in patients with metastatic renal cell carcinoma (RCC) and patients with unresectable or metastatic melanoma.
Secondary Objectives:
1. To evaluate the safety and tolerability of XTX202 monotherapy in patients with metastatic RCC and patients with unresectable or metastatic melanoma.
2. To characterize the PK profile of XTX202 in patients with metastatic RCC and patients with unresectable or metastatic melanoma.
3. To evaluate the immunogenicity of XTX202 in patients with metastatic RCC and patients with unresectable or metastatic melanoma.
4. To further evaluate the efficacy of XTX202 monotherapy in patients with metastatic RCC and patients with unresectable or metastatic melanoma.
Exploratory Objectives:
1. To evaluate the PD profile of XTX202 in patients with metastatic RCC and patients with unresectable or metastatic melanoma.
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Protocol Number:
052214
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Principal Investigator:
Sanjay Goel
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Phase:
Phase I/II
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
XTX202
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Contacts:
-
Rutgers University
Prinicipal Investigator:
Sanjay Goel
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Disease Criteria - Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available
- Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Patients must have been treated with available standard therapy. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort".
- Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an approved anti-PD-1 and a TKI. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies
- Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with an approved anti-PD-1 and an anti-CTLA4 checkpoint inhibitor 2. ECOG performance status of 0 or 1 3. Adequate organ function 4. Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.
Exclusion Criteria:
1. Received prior treatment with IL-2 therapy 2. History of clinically significant pulmonary disease 3. History of clinically significant cardiovascular disease 4. Has a diagnosis of immunodeficiency 5. Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs 6. Has an active infection requiring systemic therapy within 4 weeks prior to study treatment
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.
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A First-in-Human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects with Advanced Solid Tumors.
- NCT04485013
Primary Objective:
To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule.
Secondary Objectives(s):
(1) To characterize the single-dose and/or multiple-dose pharmacokinetics (PK) of TTX-080 following intravenous (IV) administration in subjects with advanced solid tumors.
(2) To evaluate the immunogenicity of TTX-080 in subjects with advanced solid tumors.
(3) To evaluate the preliminary antitumor activity of TTX-080 in subjects with advanced solid tumors.
Exploratory Objective: To assess the effects of TTX-080 on pharmacodynamic biomarkers relating to mechanism of action and immune responses.
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Protocol Number:
052006
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Principal Investigator:
Ryan Stephenson
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
CETUXIMAB
TTX-080
Pembrolizumab (MK-3475)
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Contacts:
-
Rutgers University
Prinicipal Investigator:
Ryan Stephenson
Read Inclusion & Exclusion Criteria
Abbreviated Inclusion Criteria:
1. Subject with histological diagnosis of advanced/metastatic cancer 2. Age 18 years or older, is willing and able to provide informed consent 3. Evidence of measurable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks
Abbreviated Exclusion Criteria:
1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody 2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
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.
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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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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.
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A Multi-Center Open-Label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients with Advanced Solid Tumors and FGF/FGFR Gene Alterations.
- NCT04565275
Study Objectives:
Phase I: Dose Escalation
Primary Objectives:
- To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors.
- To determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for ICP-192.
Secondary Objectives:
- To characterize the pharmacokinetics (PK) of ICP-192 in patients with solid tumors.
- To assess pharmacodynamics (PD) and the relationship between PK and PD of ICP-192 in patients with advanced solid tumors.
- To evaluate the preliminary anti-tumor activities of ICP-192 if the data allowed.
Phase II: Dose Expansion
Primary Objectives:
- To evaluate the preliminary anti-tumor activities of ICP-192 in patients with cholangiocarcinoma or head and neck cancer with FGF/FGFR gene alterations.
Secondary Objectives:
- To evaluate the safety and tolerability of ICP-192 in patients with cholangiocarcinoma or head and neck cancer.
- To characterize the PK of ICP-192 in patients with cholangiocarcinoma or head and neck cancer.
- To analyze the response rate in biomarker-specific subgroup.
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Protocol Number:
052205
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Principal Investigator:
Sanjay Goel
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Phase:
Phase I/II
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
ICP-192
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Contacts:
-
Rutgers University
Prinicipal Investigator:
Sanjay Goel
Read Inclusion & Exclusion Criteria
Major Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits; 2. Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available; 3. Phase II: patients with histologically or cytologically confirmed unresectable or metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapy, or have progressed/relapsed within 12 months after neoadjuvant /adjuvant chemotherapy; 4. Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration. 5. Age ≥18 years old; 6. At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1); 7. ECOG performance status of 0-1; 8. Life expectancy for more than 3 months; Must have adequate organ function Major
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: 1. Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors; 2. Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment; 3. Patients with clinically significant gastrointestinal dysfunction 4. Has known central nervous system metastases; 5. Has a history of or currently uncontrolled cardiovascular diseases 6. History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation; 7. Current evidence of corneal or retinal abnormalities that may increase eye toxicity; 8. Active hepatitis B virus active hepatitis C, or HIV infection; 9. Has not recovered from reversible toxicity of prior anti-tumor therapy 10. Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from the screening to 6 months after the last study drug administration; and fertile men who are unwilling or unable to perform contraception from screening to 3months after the last study drug administration 11. Other conditions considered by the investigator to be inappropriate for participation in this study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
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A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer (ECLIPSE).
- NCT05204927
Primary Objective:
To prospectively assess the efficacy of 177Lu-PSMA-I&T on the improvement of radiographic progression-free survival (rPFS) as determined by PCWG3-modified RECIST 1.1 in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard of care hormone therapy.
Secondary Objectives:
To assess if 177Lu-PSMA-I&T improves overall survival (OS) in patients with mCRPC
compared to those treated with standard of care hormone therapy.
Other Secondary Objectives:
1. To assess the time to the second radiographic progression event in participants who
crossover from standard of care hormone therapy to treatment with 177Lu-PSMA-I&T
(rPFS2).
2. To assess the time to progression as determined by the investigator in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy.
3. To assess the time to progression 2 as determined by the investigator in participants
treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy.
4. To evaluate the change in baseline PSA50 response rate following 177Lu-PSMA-I&T
radioligand therapy compared to standard of care hormone therapy.
5. To assess the time to first symptomatic skeletal event (SSE) following treatment with
177Lu-PSMA-I&T radioligand therapy compared to standard of care hormone therapy.
6. To evaluate the time to radiographic soft tissue progression in participants treated with
177Lu-PSMA-I&T compared to those treated with standard of care hormone therapy.
7. To evaluate the time to chemotherapy in participants treated with 177Lu-PSMA-I&T
compared to standard of care hormone therapy.
8. To assess any improvement in the quality of life measurements in participants treated
with 177Lu-PSMA-I&T compared to standard of care hormone therapy.
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Protocol Number:
082107
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Principal Investigator:
Tina Mayer M.D
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Prostate
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Therapies Involved:
Hormonal Therapy
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Drugs Involved:
177Lu-PSMA-I&T
Abiraterone
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Contacts:
-
Rutgers University
Prinicipal Investigator:
Tina Mayer M.D
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Male 18 years or older able to understand and provide signed written informed consent. 2. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component. 3. Progressive disease by one or more of the following criteria: 1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of >2 ng/mL. 2. Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria). 4. Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). 1. Must have received no more than one previous AR-directed therapy. 2. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting. 3. Must have progressed while on ARAT. 5. PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader. 6. Effective castration with serum testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration. 7. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 8. Patients with HIV that are healthy and with a low risk of acquired immune deficiency syndrome related outcomes may participate in the trial at the investigators' discretion. 9. Patients with HBV and HCV may also participate if symptoms are sufficiently managed. 10. Life expectancy of at least 6 months as assessed by investigator. 11. Willing to initiate ARAT therapy determined by investigator. 12. For patients who have partners of childbearing potential: The patient and/or partner must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 6 months after the last study drug administration.
Exclusion Criteria:
1. Prior treatment with radioligand therapy including other lutetium-labeled compounds. 2. Prior treatment with radium-223 (Xofigo) within the past 12 weeks. 3. Prior chemotherapy treatment for castration-resistant prostate cancer. Prior docetaxel use in the hormone-sensitive setting is permitted, as long as no more than 6 doses were received, the last dose was administered >1 year prior to consent, and disease progression did not occur during docetaxel treatment. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2 5. Patients with known HRR gene-mutation who have not been previously treated with olaparib or rucaparib. 6. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 7. Inadequate organ and bone marrow function as evidenced by: 1. Hemoglobin < 8 g/dL. 2. Absolute neutrophil count < 1.5 x 109/L. 3. Platelet count < 100 x 109/L. 4. AST/SGOT and/or ALT/SGPT > 3.0 x ULN. 5. Total bilirubin > 2 x ULN unless patient has known Gilbert's syndrome and then may be 3 x ULN. 6. Creatinine clearance (CrCl) < 50 mL/min based on the Cockcroft-Gault equation. 7. Albumin ≤ 2.75 g/dL 8. Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded. 9. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol. 10. Use of an investigational therapeutic drug within the last 4 weeks prior to start of study treatment or scheduled to receive one during the study period. 11. Known CNS metastasis unless received therapy, asymptomatic and neurologically stable. 12. Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization. 13. Major surgery within 30 days of randomization as determined by the Investigator. 14. Patients with active significant cardiac disease defined by any of the following: 1. New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the ICF unless treated with improvement. 2. Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias 3. History of long QT syndrome or know history of Torsades de Pointe 4. History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature 15. Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression 16. Patients with a superscan seen on baseline bone scan as determined by investigator. 17. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer 18. Previous use of G-CSF for persistent neutropenia after standard of care treatment. 19. Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy. 20. Participants with active Covid19. Recovered patients may be included when completely recovered (no symptoms at least 28 days before study medication and a negative Covid test within 72 hours).
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.
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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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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
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Principal Investigator:
Eugenia Girda Assistant
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Immunotherapy
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Drugs Involved:
Pembrolizumab (MK-3475)
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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 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.
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)
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.