RecruitingEarly Phase 1NCT04741997

Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

50 participants

Start Date

May 24, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether continuing targeted therapy (encorafenib + binimetinib) after surgery for stage III or IV melanoma with a specific BRAF mutation leads to better outcomes, especially when the tumor showed a good response to pre-surgery treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of melanoma - Your melanoma has a BRAF V600 mutation (tested in a certified lab) - Your cancer is stage III (B, C, or D) or stage IV - Your general health status is adequate (ECOG 0–2) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your melanoma does not have a BRAF V600 mutation - You have active brain metastases that are not stable - You have a history of significant heart problems - You have previously received BRAF or MEK inhibitor therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEncorafenib Pill

Encorafenib 450 mg will be administered orally once per day in continuous 28-day cycles

DRUGBinimetinib Pill

Binimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles

DRUGNivolumab

Nivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT04741997


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