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

NCT07092410 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2026-04-21

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Pierre Fabre Pharma GmbH

    collaborator INDUSTRY

  • SRH Wald-Klinikum Gera GmbH

    lead OTHER

Principal Investigators

  • Martin Kaatz, PD Dr. med. habil. · SRH Wald-Klinikum Gera GmbH

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2030-08-31
Completion
2030-08-31

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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 NCT07092410 on ClinicalTrials.gov