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

• Status: Recruiting
• Trial end date: 2024-11-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Atezolizumab

Criteria

Inclusion Criteria:

• 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 progressive 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

Exclusion Criteria:

• 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 (atezolizumab arm)