NCT07092410

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: SRH Wald-Klinikum Gera GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, prospective, single arm study conducted in Germany to investigate local treatment (i.e. surgery or radiotherapy or electrochemotherapy) of metastases showing no response to encorafenib (E) + binimetinib (B) combination therapy and continuation of EB therapy afterwards. The purpose of this study is to determine PFS of individual patients treated with local intervention while continuing therapy with EB.

Detailed description

The purpose of this prospective study is to evaluate progression free survival (PFS) of patients being treated for a minimum of 3 months with encorafenib and binimetinib and who have non-responding metastases that will be treated with local intervention while continuing combination therapy with encorafenib and binimetinib. Patients fulfilling the screening-criteria will receive local treatment of 1-3 metastases according to the investigator's decision and according to standard of care. Local treatments are not considered as study related treatments and will be carried out prior to registration. After registration patients will continue approved EB therapy as study treatment. The aim of the study is to evaluate the effects of local treatment of melanoma metastases that do not respond to EB combination therapy and subsequent continuation of EB therapy on progression-free survival. Local/surgical treatment according to standard of care (= surgery, radiotherapy, electrochemotherapy) will be at the discretion of the investigator. If there are more than one metastasis to be treated locally with different methods authorization of steering committee is required.

Conditions

• Melanoma BRAF V600E/K Mutated

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-07-29
• Last updated: 2025-07-29