Adjuvant Therapy for BRAF V600 Melanoma
This study is for people with Stage III or IV melanoma that has a specific genetic change called a BRAF V600 mutation. It's testing how well a treatment plan works to prevent the melanoma from coming back after surgery. The plan involves taking Encorafenib and Binimetinib pills, and also receiving Nivolumab through an IV. Researchers will look at how many people have their disease return within 24 weeks after surgery. To join, you must be at least 18 years old, have a confirmed melanoma diagnosis with the BRAF V600 mutation, and meet certain health requirements. The study aims to enroll 50 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. The phase of the study is not specified, and the current status is unclear.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure the rate of disease relapse after surgery up to 24 weeks.
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NCT04741997
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~50 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Encorafenib PillBinimetinib PillNivolumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Disease Relapse
Measured over After surgery up to 24 weeks
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Zeynep Eroglu, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age ≥ 18 years at the time of informed consent
Histologically confirmed diagnosis of melanoma. Any primary or unknown origin is permitted.
Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th edition).
ECOG performance status ≤ 2
Adequate laboratory parameters as well:
a. Hemoglobin ≥ 8 g/dL.
b. Platelets ≥ 75 × 109/L;
c. AST and ALT ≤ 2.5 × ULN; in participants with liver metastases ≤ 5 × ULN;
d. Total bilirubin ≤ 1.5 × ULN and \< 2 mg/dL; OR total bilirubin \>1.5 × ULN with indirect bilirubin \< 1.5 × ULN;
e. Serum creatinine ≤ 2.0 × ULN
Female participants of childbearing potential as described in protocol, must have a negative serum or urine β-HCG test result. Female participants of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, as described in Section 4.3.1. Participants must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy. Male participants must agree to use methods of contraception that are highly effective or acceptable per protocol.
Exclusion
Participants may have received prior therapy with BRAF and/or a MEK inhibitor if it was completed at least 6 months prior to study enrollment. Patients who had prior disease progression while on BRAF/MEK inhibitor therapy are not eligible. (Progression after stopping treatment is permitted.) Participants may have received prior therapy an anti-PD-1/PD-L1 or CTLA-4 inhibitor.
Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs due to toxicity.
Participants who have had major surgery or radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of such procedure.
Participants must be willing to avoid consuming grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice during the study while they are taking encorafenib/binimetinib.
Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable, require steroids, are potentially life-threatening or have required radiation within 28 days prior to starting study drug. Patients with previously treated brain metastases may participate provided they are stable (e.g.,without evidence of progression by radiographic imaging for at least 28 days before the first dose of study treatment and neurologic symptoms have returned to baseline).
Impaired cardiovascular function as below:
a. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 3);
b. presence of uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia
c. Baseline QTcF interval ≥ 500 ms.
Known history of retinal vein occlusion (RVO)
Current use of a prohibited medication (including herbal medications, supplements, or foods), as described in protocol, or use of a prohibited medication ≤ 1 week prior to the start of study treatment.
Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization.
Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization.
Pregnancy or breast feeding.
What this trial measures
- Rate of Disease RelapseAfter surgery up to 24 weeks
Investigators will estimate the rate of disease relapse after neoadjuvant therapy based on pathologic complete response status and postoperative adjuvant therapy within each arm.