Can tailored drugs after surgery keep melanoma from coming back?
NCT ID NCT04741997
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This early-phase trial tests whether giving different drug combinations after surgery, based on how well the tumor responded to initial treatment, can reduce the risk of melanoma returning. About 50 adults with stage III or IV BRAF-mutant melanoma will receive encorafenib, binimetinib, and/or nivolumab. The goal is to see if this personalized approach improves relapse-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- encorafenib, binimetinib, and nivolumab
- What this could lead to
- If successful, this could lead to a more personalized treatment plan that lowers the chance of melanoma returning after surgery.
- What could go wrong
- This is a very early, small pilot study (50 people), so results may not apply broadly. The drugs can cause side effects like nausea, fatigue, or more serious reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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