TerminatedPhase 3

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

Stopped: Sponsor decision

United States, Argentina, Australia568 participantsStarted 2017-02-17

Plain-language summary

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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria Part 1: Safety run-in * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * Aspartate transaminase (AST) \< 2.5× ULN and Alanine transaminase (ALT) \< 2.5× ULN * Measurable disease according to RECIST 1.1 * ECOG performance status ≤ 1 Part 2: Biomarker cohort * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection * Measurable disease according to RECIST 1.1 * ECOG performance status ≤ 2 Part 3: Double-blind, randomized, placebo-controlled part * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * ECOG performance status ≤ 2 * Measurable disease according to RECIST 1.1 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 me…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Up to 8 weeks (Part 1)

Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib

Timeframe: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days

Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib

Timeframe: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days

Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1

Timeframe: Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)

Trial details

NCT IDNCT02967692

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-11

Results submitted2023-06-26

View on ClinicalTrials.gov More Melanoma trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Up to 8 weeks (Part 1)

Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib

Timeframe: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days

Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib

Timeframe: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days

Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1

Timeframe: Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)