A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
The purpose of this study was to evaluate safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in patients with BRAF V600 mutant, unresectable and metastatic melanoma.
This study was designed as a phase III, multi-center study consisting of 3 parts:
For all parts of the study, the treatment continued until the subject experiences any of the following events: disease progression according to RECIST 1.1 as determined by the Investigator, unacceptable toxicity, initiation of a new anti-neoplastic therapy, pregnancy, withdrawal of consent, physician's decision, loss to follow-up, death, or termination of the study by the Sponsor. Safety evaluations are conducted for all subjects for up to 150 days after the last dose of spartalizumab/placebo (safety follow-up period).
Subjects who discontinued study treatment without disease progression as per RECIST 1.1 continued with tumor assessments according to the protocol until documented disease progression, withdrawal of consent, loss to follow-up, or death, regardless of the initiation of new anti-neoplastic therapy (efficacy follow-up period).
Subjects entered the survival follow-up period after completing the safety follow-up period or experiencing disease progression as per RECIST 1.1 or response criteria for immunotherapy, whichever period is longer (survival follow-up period).
Inclusion criteria Part 1: Safety run-in
Part 2: Biomarker cohort
Part 3: Double-blind, randomized, placebo-controlled part
Exclusion Criteria:
Part 1: Safety run-in
Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
Other protocol-defined Inclusion/Exclusion may apply.
CABA, Buenos Aires C1125ABD, Argentina
CABA, Buenos Aires C1426ANZ, Argentina
Caba, C1431FWO, Argentina
Sakyo Ku, Kyoto 606 8507, Japan
Bunkyo Ku, Tokyo 113-8677, Japan
Chuo Ku, Tokyo 104 0045, Japan
Amersfroort, 3818 ES, Netherlands
Rickmansworth Road, WD187HT, United Kingdom