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A Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma

Study acronym: RegoMel
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Dec 2024 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 2025 to Mar 2027
    • Site details revised
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Enrollment target: 16 to 48
    • Primary completion date: Dec 2022 to Dec 2024
    • Start date changed from estimate of May 2022 to Oct 3, 2022
    • Study completion date: Mar 2023 to Mar 2025
    • Interventions: Regorafenib 40 MG Oral Tablet (Drug) to Regorafenib 40 MG Oral Tablet (Drug), Triplet therapy (Drug)
    • Eligibility criteria expanded, about 377 words
    • Site details revised
    • Study arms: 1 to 3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
There are in total 3 cohorts. Cohort A: 16 patients will receive a daily dose of 80mg regorafenib up until progressive disease, unacceptable toxicity or withdrawal of consent. Dose can be escalated intra-patient up to 120 mg if no AE with a grad \>1 at 28 days. Patients get a baseline evaluation and have a consultation every 2 weeks for evaluation during treatment. This evaluation consists out of lab tests, PET/CT (not bi-weekly), MRI (not bi-weekly) and physical evaluation. Primary endpoint is the anti-tumor activity, secondary endpoints are the Overall Survival Rate, Progression Free Survival and the incidence and severity of AE and Health-Related Quality of Life. Cohort-B: 16 patients who are being treated with BRAF-/MEK- inhibitors will receive additional daily regorafenib in combination with BRAF-/MEK inhibitors. Approved BRAF-/MEK- inhibitor combinations include dabrafenib/trametinib and encorafenib/binimetinib. An interruption of BRAF-/MEK-inhibitors dosing of maximum 4 weeks is allowed between the documentation of progression of disease on this therapy and the initiation of regorafenib study treatment. Dose of regorafenib is 40mg. Cohort-C: 16 patients in Cohort-C will have interrupted treatment with any BRAF- /MEK - inhibitor combination for at least 12 weeks prior to initiating study therapy with regorafenib. At the time of initiating regorafenib study treatment at 40mg, patients will also resume treatment with encorafenib/binimetinib at its standard dosing regimen. The first 6 patients enrolled in each Cohort (B, and -C) will be considered as a safety lead-in study population. If two or more serious treatment-related adverse events are observed among the first 6 patients, enrollment will be suspended (if applicable). The risk/benefit for continuing enrollment will be evaluated and an interim safety report will be provided to the Medical Ethics Committee of the UZ Brussel. If less than two serious treatment-related adverse events are observed, enrollment will be continued without interruption to complete the phase II objective.
Trial Details
NCT Number NCT05370807
Lead Sponsor Universitair Ziekenhuis Brussel
Conditions
(from sponsor)		 Melanoma Stage III, Melanoma Stage IV
Related terms Melanoma
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov