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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 5, 2022

Primary Completion Date

April 15, 2025

Study Completion Date

April 15, 2029

Conditions
Malignant MelanomaBRAF V600 MutationBrain Metastases
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

Trial Locations (21)

Unknown

APHP - Hôpital Avicenne, Bobigny

CHU de Bordeaux - Hôpital Saint André, Bordeaux

GH Sud CHU Bordeaux - Hôpital Levêque, Bordeaux

APHP - Hôpital Ambroise Paré, Boulogne-Billancourt

CHU de Caen, Caen

CLCC - Centre Jean François Baclesse, Caen

APHP - Hôpital Henri Mondor, Créteil

CHU de Dijon - Hopital Du Bocage, Dijon

CLCC - Centre Georges François Leclerc, Dijon

CLCC - Centre Léon Bérard, Lyon

APHM - Hopital De La Timone, Marseille

CHU De Montpellier - Hopital Saint Eloi, Montpellier

CLCC - Institut de Cancerologie de Montpellier, Montpellier

CHU Nice - Hôpital de l'Archet, Nice

CLCC - Centre Antoine Lacassagne, Nice

APHP - L'hôpital de la Pitié-Salpêtrière, Paris

CHU de Nantes - Hôtel Dieu, Saint-Herblain

CLCC - Institut de Cancerologie de l'Ouest - Nantes, Saint-Herblain

CLCC - IUCT-0 / Institut Claudius Regaud, Toulouse

CHU de TOURS - Hôpital Bretonneau, Tours

CLCC - Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

European Association of Dermato Oncology

UNKNOWN

collaborator

Pierre Fabre Medicament

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

UNICANCER

OTHER

NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis | Biotech Hunter | Biotech Hunter