What is encorafenib and binimetinib studying for advanced melanoma?

Encorafenib and binimetinib are being studied to see how different adjuvant treatments after surgery may affect disease relapse in advanced melanoma with a BRAF V600 mutation. This trial aims to understand how the pathologic response to initial treatment influences outcomes. The H. Lee Moffitt Cancer Center and Research Institute is leading this research.

Who may be eligible for this melanoma clinical trial?

Adults 18 years or older with a confirmed diagnosis of melanoma carrying the BRAF V600 mutation may be eligible. Participants need a performance status of 2 or less and meet specific lab requirements. People who recently had certain therapies or have uncontrolled brain metastases may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this melanoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel or lodging may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs they may incur.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

ID04741997

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

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-02

Participants Needed

Research Sites

49 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the rate and timing of melanoma disease relapse after neoadjuvant therapy, focusing on whether participants achieve a complete pathologic response or not, and how postoperative adjuvant treatments affect outcomes. This early phase 1 trial targets patients with advanced melanoma that has a BRAF V600 mutation and evaluates different adjuvant therapies based on individual response to initial treatment. Participants will first receive 24 weeks of neoadjuvant oral encorafenib and binimetinib before planned surgery. After surgery, participants with a complete pathologic response may receive either 24 more weeks of encorafenib and binimetinib or another adjuvant treatment for 24 weeks. Those without a complete response will continue either encorafenib and binimetinib or receive nivolumab for 24 weeks. Imaging scans will be done every 12 weeks for at least one year post-surgery, then every 24 weeks for up to two additional years. During the study, participants will undergo regular imaging to monitor for disease relapse and response to treatment. Researchers will track relapse rates, survival, and response to therapy over several years. Safety and laboratory tests will also be conducted to ensure participant health. The total follow-up period includes evaluations after surgery for at least 24 weeks, with survival tracking up to five years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at the time of informed consent
Histologically confirmed melanoma diagnosis of any primary or unknown origin
Melanoma with BRAFV600 mutation, stage III (B/C/D) or stage IV as per AJCC 8th edition
ECOG performance status of 2 or less
Adequate lab values: hemoglobin ≥ 8 g/dL; platelets ≥ 75 x 10^9/L; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases; total bilirubin ≤ 1.5 x ULN and < 2 mg/dL or >1.5 x ULN with indirect bilirubin < 1.5 x ULN; serum creatinine ≤ 2.0 x ULN
Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception excluding hormonal contraceptives
Male participants must agree to use effective contraception as described in protocol

You will not qualify if you...

Prior therapy with BRAF and/or MEK inhibitors within 6 months or progression while on such therapy
Prior adverse events from encorafenib and/or binimetinib requiring drug discontinuation
Major surgery or radiotherapy within 14 days before study treatment start or incomplete recovery from such procedures
Unwillingness to avoid grapefruit, pomegranates, star fruits, Seville oranges, or their juices during treatment
Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis requiring steroids or recent radiation within 28 days
Impaired cardiovascular function including congestive heart failure (NYHA grade ≥3), uncontrolled atrial fibrillation, uncontrolled paroxysmal supraventricular tachycardia, or QTcF interval ≥ 500 ms
Known history of retinal vein occlusion
Use of prohibited medications within 1 week before treatment
Pregnancy or breastfeeding
Other malignancies interfering with safety or efficacy assessment as judged by physician
HIV infection must be well controlled with undetectable viral load
Hepatitis C infection must be treated and cured or have undetectable viral load prior to randomization

Research Team

Arnay Marshall

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