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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active enrolling
United States
EXPERIMENTAL: Arm I (encorafenib, binimetinib, nivolumab)
Patients receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
DRUG: Binimetinib
Given PO
DRUG: Encorafenib
Given PO
BIOLOGICAL: Nivolumab
Given IV
EXPERIMENTAL: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity.
BIOLOGICAL: Ipilimumab
Given IV
BIOLOGICAL: Nivolumab
Given IV
Progression-free survival
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization
Overall survival (OS)
Will be assessed by Immunotherapy Response Assessment Criteria for Intracranial Metastases (RANO-BM). Will construct Kaplan-Meier plots and estimate the median OS and construct 95% Brookmeyer-Crowley Confidence intervals.
From date of registration to date of death due to any cause, assessed up to 3 years after randomization
Intracranial response rate (ICRR)
The ICRR is defined as the best response when applying modified (m)RECIST criteria. Will compare intracranial response based on assessments per mRECIST, RANO-BM and immunotherapy (i)RANO criteria based on a review of the banked images. For each of these methods, the best response to treatment will be summarized by treatment arm, the percent agreement between each pair of methods will be reported along with a 95% confidence interval, and a p-value based on a two-sided McNemar's test will be calculated.
Up to 3 years after randomization
Objective response rate
Will be assessed by RECIST 1.1.
Up to 3 years after randomization
Duration of response
Up to 3 years after randomization
112
Sponsor: SWOG Cancer Research Network
Collaborator: National Cancer Institute (NCI)
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: