This phase III study is evaluating how safe and effective combination targeted therapy (Encorafenib and Binimetinib), compared to a targeted therapy combined with a placebo (Binimetinib and placebo), is in people with melanoma who have had prior surgery.
This trial is treating patients with melanoma with BRAF V600/K mutation.
This is a systemic therapy trial.
You may be able to join this trial if:
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group
Commercial Sponsor
Pierre-Fabre
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive encorafenib (450mg, once daily) and binimetinib (45mg, twice daily) orally for a maximum of 12 months. In the Placebo Comparator Arm, participants will receive a placebo to match encorafenib (once daily) and binimetinib (45mg, twice daily) orally for a maximum of 12 months.
Recruiting Hospitals Read More