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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
Czechia, Germany, Italy, Poland, Slovakia, Spain, United Kingdom
EXPERIMENTAL: Triplet
encorafenib and binimetinib in combination with pembrolizumab
DRUG: encorafenib
encorafenibDRUG: binimetinib
binimetinibDRUG: pembrolizumab
pembrolizumabACTIVE_COMPARATOR: Doublet
ipilimumab and nivolumab
DRUG: ipilimumab
ipilimumabDRUG: nivolumab
nivolumabObjective Response Rate (ORR) is defined as the proportion of participants in each treatment arm with a confirmed best overall response of either Complete Response (CR) or Partial Response (PR), as determined by investigator assessment per RECIST v1.1
Time from the date of randomization to the earliest date disease progression, or start of subsequent anticancer therapy, or death due to any cause (assessed up to approximately 48 months).
Progression Free Survival in each treatment arm
Time from the date of randomization to the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first (assessed up to approximately 48 months)
Overall Survival in each treatment arm
Time from date of randomization to the date of death due to any cause or the last known alive date (assessed up to approximately 48 months)
Duration of Response (CR or PR) in each treatment arm
Time from the date of the first documented response (CR or PR) to the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause (assessed up to approximately 48 months)
Disease Control Rate (proportion of participants with a confirmed best overall response of CR, PR or SD) in each treatment arm
Time from the date of randomization to the earliest date of disease progression, or start of subsequent anticancer therapy (assessed up to approximately 48 months)
Time to Response (CR or PR)
Time from the date of randomization to the date of first documented response (CR or PR), as determined by investigator assessment per RECIST v1.1 (assessed up to approximately 48 months)
Progression Free Survival 2 in each treatment arm
Time from date of randomization to date of discontinuation of next-line treatment after 1st disease progression, 2nd disease progression after initiation of next line treatment, or death due to any cause (assessed up to approximately 48 months)
Incidence and severity of Adverse Events (AEs) and changes in clinical laboratory parameters, vital signs, and cardiac assessments.
Number of participants with treatment emergent Adverse Events as as assessed per National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 4.03).
Time from first dose of study intervention through 28 days after the last dose of study intervention
Patient Reported Outcomes using EORTC QLQ-C30 questionnaires in each treatment arm
EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 includes 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/Quality of Life scale
Change from Baseline until Progressive Disease, death, withdrawal of consent, lost to follow-up, or end of study, whichever occurs first (assessed up to approximately 48 months)
Patient Reported Outcomes using EuroQOL EQ-5D-5L questionnaires in each treatment arm
The EQ-5D-5L is a standardized measure of health utility that provides a single index value of health status and contains 1 item for each of 5 dimensions of HRQoL (ie, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression).
Change from Baseline until Progressive Disease, death, withdrawal of consent, lost to follow-up, or end of study, whichever occurs first (assessed up to approximately 48 months)
BRAF V600E/K Variant Allele Frequency and/or overall mean Variant Allele Frequency from circulating tumour DNA analysis in each treatment arm
Change from baseline, Day 1 of Cycle 2 (after 3 weeks), and End of Treatment (assessed up to approximately 48 months)
150
Sponsor: Pfizer
Collaborator: Merck Sharpe & Dohme LLC
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: