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NCT02404441 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of PDR001 in Patients With Advanced Malignancies
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 319
- Enrollment target
NCT02404441: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02404441 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 319 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (432% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02404441, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 319 participants
- Enrollment target
Study Summary
The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors. By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.
Primary Outcome
Estimated the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001. AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
Interventions
- BIOLOGICAL PDR001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2015-04-27 |
| Est. Completion | 2020-07-21 |
| Phase | Phase 1 |
What the finished NCT02404441 record still lists
NCT02404441 is an interventional study that assigns participants to a tested intervention. The registered 319 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 (432% higher).
The record links to 0 conditions, and to 1 intervention - of which PDR001 is the first listed.
NCT02404441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02404441 about?
NCT02404441 is a clinical study titled "Phase I/II Study of PDR001 in Patients With Advanced Malignancies". The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors. By blocking the interaction between PD-1 and its ...
What is the current status of trial NCT02404441?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 319 participants. The study started on 2015-04-27. Estimated completion is 2020-07-21.
What interventions are being tested in trial NCT02404441?
The interventions under investigation include: PDR001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02404441?
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 NCT02404441's enrollment target sits among peer trials
319 116th of 2000 higher than 1,885 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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