Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + Binimetinib

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

August 31, 2030

Study Completion Date

August 31, 2030

Conditions
Melanoma BRAF V600E/K Mutated
Interventions
DRUG

Encorafenib & Binimetinib Treatment

The SuRage-EB post approval study will evaluate prospectively the potential impact of local treatment of melanoma metastases under encorafenib (E) + binimetinib (B) combination therapy while continuing EB therapy thereafter. It focusses on single melanoma metastases which develop resistance or show no response during EB treatment. These metastases will be treated locally before registration of the patients into the study. Directly after or during local treatment, EB combination therapy will be resumed. Locally treated EB-resistant melanoma cells cannot continue to grow during targeted therapy and the positive response may be prolonged.

All Listed Sponsors
collaborator

Pierre Fabre Pharma GmbH

INDUSTRY

lead

SRH Wald-Klinikum Gera GmbH

OTHER