A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
Trial ID or NCT#
Status
Purpose
To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma
Official Title
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
Eligibility Criteria
- Part 1: Safety run-in
- * Subjects with uveal or mucosal melanoma* Any history of CNS metastases* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollmen* Radiation therapy within 4 weeks prior to start of study treatment* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
- Parts 2 \& 3: Biomarker cohort \& double-blind, randomized, placebo-controlled part
- * Subjects with uveal or mucosal melanoma* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollment* Radiation therapy within 4 weeks prior to start of study treatment* Clinically active cerebral melanoma metastasis.* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
- Other protocol-defined Inclusion/Exclusion may apply.
Investigator(s)
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Contact
CCTO
650-725-9810
View on ClinicalTrials.gov