OncoMatch/Clinical Trials/NCT04741997
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
Is NCT04741997 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Encorafenib Pill and Binimetinib Pill for melanoma stage iii.
Treatment: Encorafenib Pill · Binimetinib Pill · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: BRAF V600
Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay)
Disease stage
Required: Stage III B, III C, III D, IV (AJCC 8th edition)
either stage III (B/C/D) or Stage IV (AJCC 8th edition)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BRAF inhibitor
Exception: if completed at least 6 months prior to study enrollment and no prior disease progression while on BRAF/MEK inhibitor therapy
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.)
Cannot have received: MEK inhibitor
Exception: if completed at least 6 months prior to study enrollment and no prior disease progression while on BRAF/MEK inhibitor therapy
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.)
Cannot have received: encorafenib (encorafenib)
Exception: no adverse events related to encorafenib and/or binimetinib that required discontinuation due to toxicity
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.
Cannot have received: binimetinib (binimetinib)
Exception: no adverse events related to encorafenib and/or binimetinib that required discontinuation due to toxicity
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.
Lab requirements
Blood counts
Hemoglobin ≥ 8 g/dL; Platelets ≥ 75 × 10^9/L
Kidney function
Serum creatinine ≤ 2.0 × ULN
Liver function
AST and ALT ≤ 2.5 × ULN; in participants with liver metastases ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN and < 2 mg/dL; OR total bilirubin >1.5 × ULN with indirect bilirubin < 1.5 × ULN
Cardiac function
Baseline QTcF interval < 500 ms; no congestive heart failure requiring treatment (NYHA Grade ≥ 3); no uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia
Adequate laboratory parameters as well: a. Hemoglobin ≥ 8 g/dL. b. Platelets ≥ 75 × 10^9/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; 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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