Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01495988 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-342

 

The purpose of this research study is to determine the effectiveness of using the study drugs vemurafenib, cobimetinib, and bevacizumab together relative to vemurafenib and cobimetinib alone. This study will investigate whether using both study drugs lengthens the amount of time before participants' melanoma worsens, increases the number of people whose melanoma responds to treatment and what the side effects are of using the drugs together rather than separately.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David McDermott, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Suzanne MacRae, 617-632-5906, smacrae@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Metastatic or unresectable stage IIIc & clearly progressive melanoma - Melanoma must be documented to contain a BRAFV600 mutation - Measurable disease - No more than 2 prior systemic treatment regimens for distant metastatic disease. The following prior therapy is permitted in either the adjuvant or metastatic setting: immunotherapy consisting of interferon, interleukin-2, GM-CSF, ipilimumab, anti-PD1 or other experimental agent; and cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin +/- paclitaxel - ECOG performance status of 0, 1, or 2 Exclusion Criteria: - Pregnant or nursing mothers - Treatment with a prior VEGF pathway, BRAF, or MEK inhibitor(s) - Receipt of any other investigational agents during the period on study or the four weeks prior to entry - Clinical evidence of active brain metastasis - Concurrent uncontrolled malignancies that require therapy or other intervention - Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study - Core biopsy, skin cancer resection, or other minor surgical procedure within 7 days prior to Day 1 of the protocol - Serious intercurrent illness - HIV-positive patients receiving combination anti-retroviral therapy
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