Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

Sponsor
UNICANCER
Study ID
NCT04074096
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotaxic radiosurgery (SRS) — RADIATION
    For patients randomised to arm B only: Upfront SRS of all lesions ≥5 mm in diameter (or ≥3 mm if other cerebral metastases \>5 mm).
  • Binimetinib Oral Tablet — DRUG
    All patients: binimetinib 45 mg PO BID.
  • Encorafenib Oral Capsule — DRUG
    All patients: encorafenib 450 mg PO QD
  • Pembrolizumab — DRUG
    All patients: pembrolizumab 200 mg IV Q3W

Study Details

This study evaluates the addition of stereotactic radiosurgery (SRS) to the combination of binimetinib + encorafenib + pembrolizumab in the treatment of BRAFⱽ⁶⁰⁰ mutation-positive melanoma with brain metastases (MBM).

Key Dates

Start date
Sep 5, 2022
Status verified
Oct 2025
Primary completion
May 7, 2026
Completion
Mar 27, 2027

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Encorafenib + binimetinib + pembrolizumab
    Encorafenib 450 mg oral route (PO) once daily (QD) + binimetinib 45 mg PO twice daily (BID) + pembrolizumab 200 mg intravenous (IV) every 3 weeks (Q3W).
  • Experimental: SRS followed by encorafenib + binimetinib + pembrolizumab
    Upfront SRS of all lesions ≥5 mm in diameter (or ≥3 mm if other cerebral metastases \>5 mm); followed by encorafenib 450 mg PO QD + binimetinib 45 mg PO BID + pembrolizumab 200 mg IV Q3W. The treatment should be started more than 24 hours and less than 8 days (excluded) after the SRS

Primary Outcome Measure

Intracranial (IC) progression-free survival (PFS) [ Time Frame: From randomisation until IC-PD, or death, whichever occurs first, up to 12 months. ]

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