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NCT03066648 · ClinicalTrials.gov registry record · Phase 1
Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 241
- Enrollment target
NCT03066648: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT03066648 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 241 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03066648, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 241 participants
- Enrollment target
Study Summary
To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients, and to identify recommended doses for future studies.
Primary Outcome
Incidence and severity of AEs and SAEs
Interventions
- DRUG Azacitidine
- DRUG Decitabine
- DRUG PDR001
- DRUG MBG453
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 1 |
What the finished NCT03066648 record still lists
NCT03066648 is an interventional study that assigns participants to a tested intervention. The registered 241 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 (302% higher).
The record links to 0 conditions, and to 4 interventions - of which Azacitidine is the first listed.
NCT03066648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03066648 about?
NCT03066648 is a clinical study titled "Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS". To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients, and to identify recommended doses for future studies.
What is the current status of trial NCT03066648?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2017-07-06. Estimated completion is 2023-09-08.
What interventions are being tested in trial NCT03066648?
The interventions under investigation include: Azacitidine (DRUG), Decitabine (DRUG), PDR001 (DRUG), MBG453 (DRUG).
Who is sponsoring clinical trial NCT03066648?
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 NCT03066648's enrollment target sits among peer trials
241 196th of 2000 higher than 1,804 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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