4 results
  • 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 (MK-6482-022) - NCT05239728

    Primary 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 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:
      Eric Singer M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eric Singer 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
  • A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]. - NCT03793166

    Primary Objective: To compare the overall survival (OS) in patients with metastatic RCC treated with ipilimumabnivolumab followed by either nivolumab versus cabozantinib-nivolumab. Secondary Objective(s): a. To determine PFS of patients treated with nivolumab versus nivolumab-cabozantinib; b. To evaluate the 12-month complete response rate in patients treated with ipilimumabnivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have CR and relapse before 12 months will not be counted as a CR at 12-months); c. To evaluate the rates of discontinuing therapy at 1 year; d. To compare objective response rates (ORR, assessed by RECIST 1.1 and irRECIST criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab; e. To document the adverse event profile of ipilimumab-nivolumab followed by cabozantinibnivolumab.

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    • Protocol Number:
      081910

    • Principal Investigator:
      Eric Singer M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

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

    • Drugs Involved:
      Cabozantinib (COMETRIQ) IPILIMUMAB (MDX-010) Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eric Singer M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • STEP I REGISTRATION CRITERIA
    • Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features.
    • Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.
    • Measurable disease as defined in the protocol.
    • Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria (1 or more of the following: Karnofsky performance status [KPS] < 80, < 1 year from diagnosis [including initial nephrectomy] to systemic treatment for metastatic disease, hemoglobin less than lower limit of normal [LLN], corrected calcium concentration greater than upper limit of normal [ULN], absolute neutrophil count greater than ULN, platelet count > ULN).
    • Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment.
    • Karnofsky performance status >= 70%.
    • No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as > 1 year since completion of systemic therapy.
    • No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 [> 28 days] and prior adjuvant sunitinib > 180 days since completion and prior immunotherapy as above are allowed).
    • No cancer therapy less than 28 days prior to registration; this includes radiation therapy, except for bone lesions less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy.
    • 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 or urine pregnancy test done =< 14 days prior to registration is required.
    • Age >= 18 years
    • Absolute neutrophil count (ANC) >= 1,500/mm^3.
    • Platelet count >= 100,000/mm^3.
    • Hemoglobin >= 8 g/dL.
    • Calculated (Calc.) creatinine clearance >= 30 mL/min.
    • Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1.
    • Total bilirubin =< 1.5 x upper limit of normal (ULN).
    • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 2.5 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present.
    • STEP 2 REGISTRATION ELIGIBILITY CRITERIA
    • Successful completion of at least 1 cycle of ipilimumabivolumab.
    • Resolution of any treatment-related adverse events to grade 1 or less per dose modification section (this criteria does not include any adverse events [AEs] not attributable to treatment which are present due to disease). Exceptions for this criteria include patients receiving replacement hormone treatments (such as levothyroxine for treatment-related hypothyroidism or glucocorticoid replacement for adrenal insufficiency). Please contact study chair if further discussion is needed.
    • No more than 70 days from last dose of ipilimumabivolumab.

    Exclusion Criteria:

    • Active autoimmune disease requiring ongoing therapy.
    • Ongoing acute toxicity > grade 2 from previous treatment.
    • History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies.
    • History of human immunodeficiency virus (HIV) or active hepatitis B/C, or active tuberculosis (purified protein derivative [PPD] response without active TB is allowed).
    • Concurrent use of immunosuppressive medication including prednisone above 10 mg daily.
    • Uncontrolled adrenal insufficiency.
    • Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP > 90 mmHg).
    • Major surgery less than 28 days prior to registration.
    • Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to registration.
    • Any arterial thrombotic events within 180 days prior to registration.
    • Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to registration.
    • Cavitating pulmonary lesions or known endotracheal or endobronchial disease manifestations.
    • Lesions encasing or invading any major blood vessels (this does not include tumor thrombus extending into/through renal vein/inferior vena cava [IVC]). Patients with tumor thrombus extending into/through renal vein are considered eligible.
    • Moderate of severe hepatic impairment (Child-Pugh B or C).
    • Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180 days prior to registration. (Any asymptomatic, treated pulmonary embolism or asymptomatic, treated deep venous thrombosis > 30 days prior to registration allowed).
    • Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms.
    • Unstable cardiac arrhythmia within 6 months prior to registration.
    • Any gastrointestinal (GI) bleeding =< 180 days, hemoptysis, or other signs of pulmonary hemorrhage =< 90 days prior to registration.
    • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration.
    • Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome within 28 days prior to registration.
    • Untreated hypothyroidism, evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome.
    • Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Allowed also in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
    • Significant cardiac ischemia events (ST elevation myocardial infarction [STEMI] or non-ST elevation myocardial infarction [NSTEMI]) within 6 months or active NY Heart Association class 3-4 heart failure symptoms

    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.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute of New Jersey
  • An Open-Label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti- PD-1/L1 Therapy - NCT04586231

    Primary Objective: - To compare MK- 6482+lenvatinib to cabozantinib with respect to PFS per Response Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). - To compare MK- 6482+lenvatinib to cabozantinib with respect to OS. Secondary Objectives: - To compare MK- 6482+lenvatinib to cabozantinib with respect to objective response rate (ORR) based on RECIST 1.1 as assessed by BICR. -To evaluate the duration of response (DOR) as assessed by BICR according to RECIST 1.1. - To evaluate the safety and tolerability of MK-6482+lenvatinib compared to cabozantinib.

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    • Protocol Number:
      082005

    • Principal Investigator:
      Eric Singer M.D

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

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

    • Drugs Involved:
      MK-6482 Cabozantinib (COMETRIQ) Lenvatinib (E7080/MK-7902)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eric Singer M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
    • Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment with progression on or within 6 months of last dose.
    • Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
    • Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
    • Received no more than 2 prior systemic regimens.
    • Received only 1 prior antiPD-1/L1 therapy for adjuvant or locally advanced/metastatic RCC.
    • A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
    • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
    • Adequately controlled blood pressure.
    • Adequate organ function.

    Exclusion Criteria:

    • A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
    • Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
    • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
    • Clinically significant cardiac disease within 6 months of first dose of study intervention.
    • Prolongation of QTc interval to >480 ms.
    • Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable.
    • Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
    • Moderate to severe hepatic impairment.
    • History of significant bleeding within 3 months before randomization.
    • History of solid organ transplantation.
    • Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
    • Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
    • Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
    • Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization.
    • Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
    • Prior treatment with lenvatinib.
    • Prior treatment with cabozantinib.
    • Currently participating in a study of an investigational agent or using an investigational device.
    • Active infection requiring systemic therapy.
    • History of human immunodeficiency virus (HIV) infection.
    • History of hepatitis B or known active hepatitis C infection.

    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
  • Cyto-KIK; TRIAL (CYTO reductive surgery in Kidney cancer plus Immunotherapy (nivolumab) and targeted Kinase inhibition (cabozantinib). - NCT04322955

    Primary Clinical Objective: The primary clinical objective is to determine the complete response rate in patients receiving neoadjuvant nivolumab and cabozantinib followed by nephrectomy and subsequent systemic therapy, at any time while on study treatment.

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    • Protocol Number:
      082002

    • Principal Investigator:
      Eric Singer M.D

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

    • Therapies Involved:
      Chemotherapy multiple agents systemic Surgery

    • Drugs Involved:
      Cabozantinib(XL184) Opdivo (Nivolumab) Cabozantinib (COMETRIQ)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eric Singer M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Written informed consent and HIPAA authorization for release of personal health information. 2. Age ≥ 18years at the time of consent. 3. ECOG Performance Status of 0-1 within 28 days prior to registration. 4. Radiographically consistent with metastatic renal cell carcinoma (with subsequent pathologic confirmation of renal cell carcinoma with a clear cell component) OR histological/ cytological evidence of metastatic renal cell carcinoma with a clear cell component 5. Measurable tumor in the kidney according to RECIST 1.1 6. No prior therapy for metastatic renal cell carcinoma 7. Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 14 days prior to registration. 8. Females of childbearing potential must have a negative serum pregnancy test during screening, within 14 days of Cycle 1 Day 1. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months 9. Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. 10. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

    Exclusion Criteria:

      1. Patients who had previously undergone nephrectomy for renal cancer are excluded 2. Uncontrolled bleeding, hypertension, or cardiovascular disease. 3. Prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA-4 inhibitors 4. The subject has active brain metastases or epidural disease 5. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. 6. The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test ≥1.3 x the laboratory ULN 7. The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, thrombin or Factor Xa inhibitors. Aspirin (up to 325 mg/day), low-dose warfarin (≤1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted 8. Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment 9. Hemoptysis of ≥0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment 10. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. 11. The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib 12. Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment 13. Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study start 14. Cardiovascular disorders including:
    • Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening
    • Concurrent uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic, or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 14 days of the first dose of study treatment.
    • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) >500 ms within 28 days before registration. 15. Severe active infection requiring systemic treatment within 28 days before the first dose of study treatment 16. Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment 17. Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. 18. History of organ transplant 19. Concurrent uncompensated hypothyroidism 20. Unable to swallow tablets 21. Active infection requiring systemic therapy 22. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). 23. Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least 2 years. 24. Active central nervous system (CNS) metastases 25. Treatment with any investigational drug within 28 days prior to registration.

    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