Status:
ACTIVE_NOT_RECRUITING
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.
Lead Sponsor:
Genentech, Inc.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 nivolumab in patients with NRAS-mut...
Detailed Description
The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm); a belvarafenib plus cobimetinib arm (Belva + Cobi arm) in an initial dose-finding phase foll...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04835805
Start Date
May 13 2021
End Date
December 31 2025
Last Update
December 31 2025
Active Locations (17)
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1
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
2
UCSF Helen Diller Family CCC
San Francisco, California, United States, 94158
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
4
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231