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.
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 Status 0 Or 1. Documented Evidence Of A Braf V600e Or V600k Mutation In Melanoma Tumor Tissue As Previously Determined By Either Pcr Or Ngs-Based Local Laboratory Assay. Adequate Bone Marrow Function, Hepatic And Renal Function. No Mucosal Or Ocular Melanoma. No Diagnosis Of Immunodeficiency Or An Active Autoimmune Disease That Required Systemic Treatment In The Past 2 Years. No Clinically Significant Multiple Or Severe Drug Allergies, Intolerance To Topical Corticosteroids, Or Severe Post-Treatment Hypersensitivity Reactions. No Impairment Of Gi Function Or Disease Which May Significantly Alter The Absorption Of Oral Study Intervention. No Clinically Significant Cardiovascular Diseases. No Concurrent Neuromuscular Disorder That Is Associated With The Potential Of Elevated Ck. No Evidence Of Hbv Or Hcv Infection.
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Uc Cancer Center