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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, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom
EXPERIMENTAL: Arm A: encorafenib, cetuximab and pembrolizumab
Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.
DRUG: Encorafenib
capsuleBIOLOGICAL: Cetuximab
IVBIOLOGICAL: Pembrolizumab
IVACTIVE_COMPARATOR: Arm B: pembrolizumab
Participants receive pembrolizumab IV.
BIOLOGICAL: Pembrolizumab
IVProgression-free Survival (PFS)
PFS per investigator, defined as the time from randomization until PD based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first:
Duration of study, approximately 45 months
Incidence of adverse events
Incidence and severity of AEs graded according to the NCI CTCAE v4.03: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Duration of study, approximately 45 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Duration of study, approximately 45 months
Objective Response (OR)
OR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Duration of study, approximately 45 months
104
Sponsor: Pfizer
Collaborator: Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany, Eli Lilly and Company
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: