Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Bra… (NCT04074096) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis
France10 participantsStarted 2022-09-05
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provided written informed consent prior to any trial specific procedures.
✓. Aged ≥18 years old.
✓. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
✓. Histologically confirmed Stage IV M1d cutaneous melanoma or unknown primary melanoma that is metastatic to the brain.
✓. Presence of BRAFV600E/K/D/R mutation according to a locally validated BRAF Assay.
✓. Candidacy for SRS therapy validated by the radiation oncologist and/or neurosurgeon at the investigative centre. This should be documented in the patient file.
✓. Absence of previous systemic treatment with BRAF inhibitors, MEK inhibitors or anti-PD-1 for distant metastatic melanoma. Patients having received such treatments as adjuvant therapy are allowed provided adjuvant treatment has been stopped for 6 months or more.
✓. No more than one previous local intracranial therapy for one lesion (e.g. craniotomy, SRS).
Exclusion criteria
✕. More than 10 intracranial metastases.
✕. Presence of neurological symptoms related to intracranial metastases which induce alteration of the ECOG performance status to 2 or more or require immediate radiation treatment.
✕. Ocular melanoma.
✕
What they're measuring
1
Intracranial (IC) progression-free survival (PFS)
Timeframe: From randomisation until IC-PD, or death, whichever occurs first, up to 12 months.
. Brain metastases which necessitate immediate neurosurgery.
✕. Any previous treatment with whole-brain radiation.
✕. Presence of leptomeningeal disease or any parenchymal brain metastasis \>30 mm in longest diameter.
✕. Current or expected use of a strong inhibitor of CYP3A4.
✕. History of malignancy other than disease under study occurring within 3 years of study enrolment with the exception of: completely resected non-melanoma skin cancer or indolent second malignancies.