Clareo Health | 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.
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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
