Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02967692) enrolled a total of 568 participants across four groups. It tested a combination of three medicines — spartalizumab (PDR001), dabrafenib, and trametinib — against dabrafenib and trametinib alone (with a placebo standing in for spartalizumab). The trial ran in three parts: a small safety check (Part 1, 9 people), a biomarker study to look at changes inside tumour and blood samples (Part 2, 27 people), and a larger randomised comparison (Part 3, 267 people in the combination arm and 265 in the placebo arm). No participants were recorded as having formally "completed" the study, meaning all had left the trial before the study closed — most commonly because the study ended or their condition changed. The reported data shows the following results across the trial's parts. In Part 1, 1 out of 9 participants experienced what the trial defined as a dose-limiting toxicity (a significant side effect occurring within the first 8 weeks). In Part 2, changes in two biological markers were recorded: a protein on tumour cells called PD-L1 showed a reported change of 1.7 to 2.7 percentage points from the starting level, and a type of immune cell in the blood (CD8+ cells) showed a reported change of 0.4 to 1.2 percentage points. In the main randomised comparison (Part 3), the reported median time before a participant's disease progressed or they died — known as progression-free survival — was 16.2 months in the spartalizumab combination group and 12.0 months in the placebo group. For overall survival (time from the start of the study until death from any cause), the reported median figures were 61.5 months in the combination arm and 41.6 months in the placebo arm. The proportion of participants whose tumours shrank or disappeared (overall response rate) was reported as 68.5% in the combination arm and 64.2% in the placebo arm. Overall survival data for Part 1 was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Melanoma Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with melanoma (confirmed by biopsy) that has spread or cannot be removed by surgery, and your tumor has a specific gene change called a BRAF V600 mutation
- Your cancer can be measured on a scan (according to standard medical guidelines)
- You are generally well enough to carry out light activities or normal daily tasks (your doctor can assess this)
- (Part 1 only) Your liver function test results are within an acceptable range — specifically, two markers called AST and ALT are not too elevated (confirm with trial site)
- (Part 2 only) You have at least two skin, under-skin, or lymph node tumors that can be sampled for research purposes
Who may not be able to join:
- Your melanoma started in the eye (uveal melanoma) or in the mucous membranes, such as inside the mouth or nose (mucosal melanoma)
- You have previously received systemic (whole-body) cancer treatment for your advanced or metastatic melanoma
- You received melanoma treatment before or after surgery, and that treatment finished less than 6 months ago
- You have had radiation therapy within the 4 weeks before starting the study treatment
- You have or have had an autoimmune disease (where the immune system attacks the body) that needed medical treatment
- (Part 1 only) You have ever had cancer that spread to the brain or spine (central nervous system)
- (Parts 2 & 3 only) You currently have active melanoma tumours in the brain that are causing symptoms (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs); 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; Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib; Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.