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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
Scope: National
Applicable Disease Sites: Kidney
Therapies Involved: Chemotherapy multiple agents systemic
Drugs Involved: ERLOTINIB Atezolizumab (MPDL3280A) BEVACIZUMAB
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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.
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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
Principal Investigator: Biren Saraiya M.D
Therapies Involved: Surgery Chemotherapy multiple agents systemic
Drugs Involved: Cabozantinib (XL184) Cabozantinib(XL184) Opdivo (Nivolumab)
Primary Objective To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria. Secondary Objectives To assess the safety, toxicity and tolerability of the two treatment strategies as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5 in each treatment arm. To assess the objective response rate (ORR) by iRECIST in each treatment arm. Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified indications (nrPFS2). Radiographic progression-free survival (rPFS) . To assess overall survival (OS) in each treatment arm. To assess the time to subsequent second-line therapy or death in each treatment arm. To assess the rate of cytoreductive nephrectomy in each treatment arm. To assess treatment-free survival in patients who discontinue therapy for reason other than radiographic disease progression. To assess the ORR by RECIST version 1.1 and iRECIST in the primary renal mass.
Protocol Number: 082305
Principal Investigator: Lara Hathout MD
Therapies Involved: Chemotherapy multiple agents systemic Radiotherapy
Drugs Involved: Cabozantinib (XL184) Pembrolizumab (MK-3475) Axitinib Opdivo (Nivolumab) IPILIMUMAB (MDX-010) Lenvatinib (E7080/MK-7902)
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