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A Phase 1B Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Combination of Encorafenib, Binimetinib and Palbociclib in Patients With BRAF-mutant Metastatic Melanoma (The CELEBRATE Study)
Other Non-Commercial Sponsor
Peter MacCallum Cancer Centre
This trial contains a dose escalation phase and a dose expansion phase, designed to assess the safety, tolerability, and pharmacokinetics of encorafenib, binimetinib and palbociclib in combination for the treatment of BRAF-mutant metastatic melanoma. Patients with untreated or previously treated BRAFV600 mutation-positive, locally advanced/unresectable or metastatic melanoma are eligible.
In the dose escalation phase of the trial, eligible patients will raceive 450mg oral Encorafenib daily, Binimetinib twice daily and a variable dose of Palbociclib daily for 21 consecutive days on treatment, followed by 7 days off treatment in a 28-day cycle. Alternate dosing regimens and schedules may be interrogated depending on the nature and timing of the toxicities encountered.
Approximately 30 additional patients will be enrolled into two dose expansion cohorts. One cohort will consist of previously untreated patients or treated patients without prior exposure to any BRAF and MEK inhibitor therapy. The second cohort will consist of patients who have progressed on BRAF and MEK inhibitor therapy. A minimum of 10 patients in each cohort must have newly obtained tumour sample at baseline. Accrual may be restricted to achieve this. Treatment of patients in both phases will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion is met.