A Study of The Safety and Pharmacology of MPDL3280A Administered in Combination With Vemurafenib (Zelboraf®) in Patients With Previously Untreated BRAFV600-Mutation Positive Metastatic Melanoma

Status: Recruiting
Phase:
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01656642 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-376

 

This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of MPDL3280A in combination with Vemurafenib (Zelboraf®) in previously untreated patients with BRAFV600-mutation positive metastatic melanoma.

 

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

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

Site-responsible Investigators:
David McDermott, MD, Beth Israel Deaconess Medical Center
Donald Lawrence, MD, Massachusetts General Hospital

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
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologic or cytologic documentation of metastatic melanoma, with BRAFV600 mutation as assessed by cobas® 4800 BRAF V600 Mutation Test. Origin of the primary tumor must be known and may be of skin, mucosal, or acral locations but not of ocular origin. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic and end organ function - Measurable disease per RECIST v1.1 - For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for 6 months after discontinuation from the study Exclusion Criteria: - Receipt of prior systemic anti-cancer therapy for unresectable, locally advanced or metastatic melanoma - Receipt of prior MAPK inhibitor pathway agents, including MEK kinase inhibitor and BRAF kinase inhibitor - Major surgical procedure within 28 days prior to Day 1 or anticipation of need for a major surgical procedure during the course of the study - Radiotherapy </= 14 days prior to Day 1 - Adverse events from prior anti-cancer therapy that have not resolved to Grade <= 1 except for alopecia - Current severe, uncontrolled systemic disease excluding cancer - Known clinically significant liver disease - Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases - Any ongoing malignancy other than melanoma - History or risk of autoimmune disease - History of idiopathic pulmonary fibrosis, risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest CT scan - History of HIV or hepatitis C infection - Active tuberculosis - Severe infections within 4 weeks prior to Cycle 1 Day 1 or Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1 - Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1 - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study - History of clinically significant cardiac or pulmonary dysfunction - Treatment with systemic immunosuppressive medications within 4 weeks prior to Cycle 1 Day 1 - Bisphosphonate therapy for symptomatic hypercalcemia - Pregnant or lactating women - Any vemurafenib-specific exclusion criteria
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