A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
Trial ID or NCT#
NCT02967692
Status
NOT RECRUITING
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
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Exclusion 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)
Sunil Arani Reddy
Medical oncologist,
Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Contact us to find out if this trial is right for you.
Contact
CCTO
650-725-9810
View on ClinicalTrials.gov
