A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.

Running, not enrolling · Phase 1

Conditions studied: Melanoma

In brief

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

Key facts

Study ID

NCT04835805

Run by

Genentech, Inc.

People needed

65

Starts

2021-05-13

Expected to finish

2026-12-31

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG Performance Status of 0 or 1
• Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received up to two lines of systemic cancer therapy. Treatment with anti-PD-1/PD-L1 in the adjuvant setting is acceptable. Patients must have progressed disease at study entry
• Documentation of NRAS mutation-positive within 5 years prior to screening
• Tumor specimen availability
• Adequate hematologic and end-organ function
• Measurable disease per RECIST v1.1

You may not qualify if…

• Prior treatment with a pan-RAF inhibitor
• Treatment with systemic immunotherapy agents (e.g., anti-CTLA4, anti-PD(L)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to C1D1
• Symptomatic, untreated, or actively progressing CNS metastases
• History or signs/symptoms of clinically significant cardiovascular disease
• Known clinically significant liver disease
• History of autoimmune disease or immune deficiency
• Prior treatment with a MEK inhibitor (cobimetinib arm)
• History of or evidence of retinal pathology on ophthalmologic examination (cobimetinib arm)
• History of immune-related AE attributed to prior anti-PD(L)1 therapy that resulted in permanent discontinuation of anti-PD(L)1 therapy (nivolumab arm)

Where it is running

• California Pacific Medical Center Research Institute — San Francisco, California, United States
• UCSF Helen Diller Family CCC — San Francisco, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering — New York, New York, United States
• Calvary Mater Newcastle — Waratah, New South Wales, Australia
• Peter MacCallum Cancer Centre-East Melbourne — Melbourne, Victoria, Australia
• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia
• Ottawa Hospital Regional Cancer Centre — Ottawa, Ontario, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• Klinikum Mannheim GmbH Universitätsklinikum — Mannheim, Germany
• Universitatsklinikum Tubingen — Tübingen, Germany
• Universitätsklinikum Würzburg — Würzburg, Germany
• Asan Medical Center - PPDS — Seoul, South Korea
• Samsung Medical Center - PPDS — Seoul, South Korea

Full record on ClinicalTrials.gov

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