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Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

NCT04074096 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-25

No results posted yet for this study

Summary

This study evaluates the addition of stereotactic radiosurgery (SRS) to the combination of binimetinib + encorafenib + pembrolizumab in the treatment of BRAFⱽ⁶⁰⁰ mutation-positive melanoma with brain metastases (MBM).

Conditions

Interventions

RADIATION

Stereotaxic radiosurgery (SRS)

For patients randomised to arm B only: Upfront SRS of all lesions ≥5 mm in diameter (or ≥3 mm if other cerebral metastases \>5 mm).

DRUG

Binimetinib Oral Tablet

All patients: binimetinib 45 mg PO BID.

DRUG

Encorafenib Oral Capsule

All patients: encorafenib 450 mg PO QD

DRUG

Pembrolizumab

All patients: pembrolizumab 200 mg IV Q3W

Sponsors & Collaborators

  • European Association of Dermato Oncology

    collaborator UNKNOWN

  • Pierre Fabre Medicament

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Philippe Saiag, Prof · APHP - CHU Ambroise Paré

  • Marie Charissoux, MD · Institut Régional du Cancer

  • Jean Regis, Prof · APHM - Hôpital de la Timone

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2026-03-27
Completion
2026-03-27

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
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 NCT04074096 on ClinicalTrials.gov