C4221016 A Phase 3, Randomized, Double-Blind Study Of Encorafenib And Binimetinib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab In Participants With Braf V600e/K Mutation-Positive Metastatic Or Unresectable Locally Advanced Melanoma
Posted Date: Jul 6, 2021
- Investigator: Rekha Chaudhary
- Specialties: Cancer, Oncology
- Type of Study: Drug
The primary purpose of this study is to compare the efficacy, safety, and tolerability of encorafenib and binimetinib plus pembrolizumab (Triplet Arm) versus placebo plus pembrolizumab (Control Arm) in participants with metastatic or unresectable locally advanced BRAF V600E/K mutation-positive melanoma. Efficacy will be measured by Safety Lead In: Incidence of Dose Limiting Toxicities and Phase 3: Progression Free Survival (PFS). Participants in the experimental triplet arm will receive Encorafenib and Binimetinib in combination with Pembrolizumab. Participants in the control arm will receive Pembrolizumab.
Criteria:
Histologically Confirmed Unresectable (Stage Iiib, Iiic, Or Iiid) Or Metastatic (Stage Iv) Cutaneous Melanoma. Presence Of At Least 1 Measurable Lesion As Detected By Radiological And/Or Photographic Methods According To Recist V1.1. Ecog Performance Stat
Keywords:
Melanoma
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com