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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 319 participants.
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.
Interventions
- BIOLOGICAL PDR001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2015-04-27 |
| Est. Completion | 2020-07-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02404441
The ClinicalTrials.gov registry entry for NCT02404441 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PDR001 is the first listed.
NCT02404441 reports 0 study locations.
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.
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