A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT02967692

Run by

Novartis Pharmaceuticals

People needed

568

Starts

2017-02-17

Expected to finish

2024-08-21

Last updated by the study team

2025-09-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• UC Irvine Medical Center — Orange, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Stanford Cancer Center — Stanford, California, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Johns Hopkins U — Lutherville, Maryland, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• NYU Laura and Isaac Perlmutter Cancer Center — New York, New York, United States
• University of Pittsburgh Med Center — Pittsburgh, Pennsylvania, United States
• University of Tennessee Medical Ctr — Knoxville, Tennessee, United States
• Univ of TX MD Anderson Cancer Cntr — Houston, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — Caba, Argentina
• Novartis Investigative Site — Gateshead, New South Wales, Australia
• Novartis Investigative Site — North Sydney, New South Wales, Australia
• Novartis Investigative Site — Greenslopes, Queensland, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Nedlands, Western Australia, Australia
• Novartis Investigative Site — Innsbruck, Tyrol, Austria
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Salzburg, Austria
• California Cancer Associates for Research and Excellence — Encinitas, California, United States

Full record on ClinicalTrials.gov

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