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NCT03980041 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
A Phase 2 study, sponsored by Infinity Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT03980041: Completed Phase 2 study, sponsored by Infinity Pharmaceuticals.
NCT03980041 is a Phase 2 study that has completed, run by Infinity Pharmaceuticals. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03980041, a Phase 2 study, has completed, sponsored by Infinity Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.
Primary Outcome
ORR is defined as best response of complete response (CR) or partial response (PR) as measured by RECIST v1.1. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Interventions
- DRUG Nivolumab
- DRUG Placebos
- DRUG IPI-549 (eganelisib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 2 |
What the finished NCT03980041 record still lists
NCT03980041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03980041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03980041 about?
NCT03980041 is a clinical study titled "Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)". The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.
What is the current status of trial NCT03980041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2019-09-25. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT03980041?
The interventions under investigation include: Nivolumab (DRUG), Placebos (DRUG), IPI-549 (eganelisib) (DRUG).
Who is sponsoring clinical trial NCT03980041?
This trial is sponsored by Infinity Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03980041's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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