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

NCT04741997 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV
  • BRAF V600 Mutation

Interventions

DRUG

Encorafenib Pill

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

DRUG

Binimetinib Pill

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

DRUG

Nivolumab

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Zeynep Eroglu, MD · Moffitt Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2026-07-22
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741997 on ClinicalTrials.gov