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Primary Objective: To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS. Secondary Objectives: - To compare overall survival (OS) for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (2): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to OS. - To compare the safety and tolerability profiles for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. - To compare measures of disease recurrence-specific survival (DRSS) as assessed by the investigator, in participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. - To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 30 Questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-related Symptoms (FKSI-DRS).
Protocol Number: 082106
Principal Investigator: Biren Saraiya M.D
Phase: Phase III
Scope: National
Applicable Disease Sites: Kidney
Therapies Involved: Chemotherapy single agent systemic
Drugs Involved: Belzutifan (MK-6482)
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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.
Primary Objective: - To assess the complete response (CR) rate according to standard Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in patients with 1) advanced RCC associated with HLRCC and 2) advanced sporadic/non-HLRCC papillary renal cell cancer treated with a combination of bevacizumab, erlotinib, and atezolizumab. Secondary Objectives: - To determine the safety and tolerability of the combination of bevacizumab, erlotinib, and atezolizumab. - To determine the objective response rate (ORR) as complete response (CR) + partial response (PR). - To determine disease control rate (DCR) - confirmed response, or stable disease (SD) lasting for at least 6 months. - To assess progression-free survival time (PFS) according to RECIST 1.1. - To assess overall survival (OS). - To assess the duration of response. - To assess response to treatment using iRECIST.
Protocol Number: 082203
Principal Investigator: Ryan Stephenson
Phase: Phase II
Therapies Involved: Chemotherapy multiple agents systemic
Drugs Involved: ERLOTINIB Atezolizumab (MPDL3280A) BEVACIZUMAB
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.
Protocol Number: 082005
Phase: Phase II/III
Therapies Involved: Chemotherapy single agent systemic Chemotherapy multiple agents systemic
Drugs Involved: MK-6482 Cabozantinib (XL184) Lenvatinib (E7080/MK-7902)
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.
Protocol Number: 082002
Therapies Involved: Surgery Chemotherapy multiple agents systemic
Drugs Involved: Cabozantinib (XL184) Opdivo (Nivolumab) Cabozantinib(XL184)
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.
Protocol Number: 081910
Drugs Involved: Opdivo (Nivolumab) IPILIMUMAB (MDX-010) Cabozantinib (XL184)
GOALS AND OBJECTIVES (SCIENTIFIC AIMS) 1. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the event-free survival (EFS) of patients with newly diagnosed Stage 4 diffuse anaplastic Wilms tumor (DAWT) as compared to historical controls. 2.To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS of patients with Standard-Risk relapsed favorable histology Wilms tumor (SRrFHWT) as compared to historical controls. 3. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the overall survival (OS) of patients with newly diagnosed Stage 4 DAWT as compared to historical controls. 4. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the OS of patients with SRrFHWT as compared to historical controls. 5. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide /carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS and OS of patients with newly diagnosed Stage 2 and 3 DAWT as compared to historical controls. 6. To establish EFS and OS for High-Risk (HRrFHWT) and Very High-Risk (VHRrFHWT) relapsed favorable histology Wilms tumor treated with ifosfamide/carboplatin/etoposide alternating with cyclophosphamide/ topotecan.
Protocol Number: 112106
Principal Investigator: Scott Moerdler M.D.
Drugs Involved: Cefixime
The overall study objective is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers. This developmental work is imperative as the VERDI models utilized at DFCI in research studies #18-411 (ProActive), #17-409 (ProGen), #19-068 (OPT-IN), and #19-652 (GeneBOPP) have been overwhelmingly used in DFCI patients of Caucasian ancestry. While DFCI participants have responded well, in an effort improve the generalizability of VERDI and expand it to a diverse patient population, qualitative feedback is being sought explicitly from patients who self-identify as Black and Latinx patients. A brief qualitative assessment among a small, cohort of English and Spanish speaking Black and Latinx participants will first be conducted to identify refinements to video education (VE) that may increase the utility of the VERDI model for patients in these traditionally underserved populations. Participants in the qualitative assessment study will receive VE exclusively for pretest education, followed by a short interview with research staff regarding their experiences with the VE model. The qualitative assessment study will precede a large-scale randomized controlled trial of VERDI vs standard genetic counseling (SGC), as informed by the results of the developmental study. We hypothesize that the data yielded from the completion of the study objectives will assist in further refining the VERDI model and its use in clinical practices for the purpose of increasing genetic testing uptake and improving patient outcomes in minority populations that have been underrepresented in similar research to date.
Protocol Number: 042207
Principal Investigator: Deborah Toppmeyer M.D.
Phase: N/A
Applicable Disease Sites: Pancreas,Melanoma, Skin,Colon,Ovary,Soft Tissue,Prostate,Kidney,Breast