Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metasta… (NCT07092410) | Clinical Trial Compass
WithdrawnPhase 4
Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + Binimetinib
Stopped: The study was terminated early due to insufficient patient recruitment.
0Started 2025-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form
✓. Female and male patients ≥ 18 years of age
✓. Ability to comply with the study protocol, in the investigator's judgement
✓. Ongoing treatment with Encorafenib plus Binimetinib (EB) in accordance with the current Summary of Product Characteristics (SmPC) for a minimum of 3 months
✓. ECOG performance status 0-2
✓. Life expectancy ≥ 12 weeks
✓. Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous or unknown primary melanoma (inoperable stage III or metastatic stage IV, per AJCC 8 staging)
✓. Presence of a BRAFV600-mutation according to a validated test
Exclusion criteria
✕. Signed informed consent form
✕. Female and male patients ≥ 18 years of age
✕. Ability to comply with the study protocol, in the investigator's judgement
✕. Ongoing treatment with Encorafenib plus Binimetinib (EB) in accordance with the current Summary of Product Characteristics (SmPC) for a minimum of 3 months
✕. ECOG performance status 0-2
What they're measuring
1
Progression Free Survival (PFS) after local treatment (radiotherapy / surgery / electrochemotherapy)
Timeframe: From enrollment up to end of treatment period after 52 weeks maximum.
✕. Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous or unknown primary melanoma (inoperable stage III or metastatic stage IV, per AJCC 8 staging)
✕. Presence of a BRAFV600-mutation according to a validated test