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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.
- Cancer
- Melanoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Aurora
- Baltimore
- Bergen
- Berlin
- Hamburg
- Iowa City
- Mannheim
- Melbourne
- Montréal
- Nashville
- Nedlands
- New York
- Orange
- Oslo
- Ottawa
- San Francisco
- Seoul
- St. Louis
- Toronto
- Tübingen
- Waratah
- Würzburg
Trial Identifier:
NCT04835805 2020-003674-41 GO42273
Trial 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-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT04835805,GO42273,2020-003674-41
Trial Identifier
Belvarafenib, Cobimetinib, Nivolumab
Treatments
Melanoma
Condition
Official Title
A Phase Ib, Open-Label, Multicenter Study to 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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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 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 Criteria
- 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)
For the latest version of this information please go to www.forpatients.roche.com