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NCT02967692 · ClinicalTrials.gov registry record · Phase 3
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
NCT02967692: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02967692 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 568 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02967692, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
Study 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.
Primary Outcome
DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or hi
Interventions
- OTHER Placebo
- DRUG Trametinib
- DRUG Dabrafenib
- BIOLOGICAL Spartalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2017-02-17 |
| Est. Completion | 2024-08-21 |
| Phase | Phase 3 |
Why NCT02967692 stopped before completion
NCT02967692 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02967692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02967692 about?
NCT02967692 is a clinical study titled "A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma". 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.
What is the current status of trial NCT02967692?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2017-02-17. Estimated completion is 2024-08-21.
What interventions are being tested in trial NCT02967692?
The interventions under investigation include: Placebo (OTHER), Trametinib (DRUG), Dabrafenib (DRUG), Spartalizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02967692?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02967692's enrollment target sits among peer trials
568 666th of 2000 higher than 1,334 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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