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NCT02460224 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 490
- Enrollment target
NCT02460224: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02460224 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 490 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (717% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02460224, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 490 participants
- Enrollment target
Study Summary
This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically signific
Interventions
- DRUG PDR001
- DRUG LAG525
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2015-06-17 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 1 |
What the finished NCT02460224 record still lists
NCT02460224 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (717% higher).
The record links to 0 conditions, and to 2 interventions - of which PDR001 is the first listed.
NCT02460224 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02460224 about?
NCT02460224 is a clinical study titled "Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.". This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tol...
What is the current status of trial NCT02460224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 490 participants. The study started on 2015-06-17. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT02460224?
The interventions under investigation include: PDR001 (DRUG), LAG525 (DRUG).
Who is sponsoring clinical trial NCT02460224?
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 NCT02460224's enrollment target sits among peer trials
490 47th of 2000 higher than 1,953 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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