Melanoma Clinical Trial
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.
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.
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 followed by an expansion phase and a belvarafenib plus cobimetinib plus nivolumab arm (Belva + Cobi + Nivo arm) in a run-in phase followed by an expansion phase.
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
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)
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There are 24 Locations for this study
Orange California, 92868, United States
San Francisco California, 94115, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21287, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Nashville Tennessee, 37203, United States
Waratah New South Wales, 2298, Australia
Melbourne Victoria, 3000, Australia
Nedlands Western Australia, 6009, Australia
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Berlin , 10117, Germany
Hamburg , 20246, Germany
Mannheim , 68167, Germany
Tübingen , 72076, Germany
Würzburg , 97080, Germany
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Bergen , 5053, Norway
Oslo , 0379, Norway
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