Encorafenib, Binimetinib and Palbociclib in BRAF-mutant Metastatic Melanoma CELEBRATE
Status:
Recruiting
Trial end date:
2023-12-04
Target enrollment:
Participant gender:
Summary
This is an open-label, phase IB, non-randomised study consisting of a dose escalation phase
and expansion phase, evaluating the safety, tolerability and preliminary efficacy of the
combination of encorafenib, binimetinib and palbociclib in patients with BRAF-mutant
metastatic melanoma.
Dose escalation phase: Previously treated or treatment-naïve patients will be evaluated after
the first cycle for dose-limiting toxicities to ascertain the recommended phase 2 dose (RP2D)
of encorafenib, binimetinib and palbociclib.
Expansion phase: Two cohorts of patients will be further evaluated for the efficacy and
safety of the RP2D of palbociclib with encorafenib and binimetinib. Cohort 1 will include
patients naïve to both BRAF and MEK inhibitors. Cohort 2 will include patients with either
primary or acquired resistance to both BRAF and MEK inhibitors.