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NCT03955471 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
A Phase 2 study, sponsored by Tesaro.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT03955471: Clinical Trial Phase 2 study, sponsored by Tesaro.
NCT03955471 is a Phase 2 study that was terminated before completion, run by Tesaro. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03955471, a Phase 2 study, was terminated before completion, sponsored by Tesaro.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.
Primary Outcome
ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or partial response (PR), as determined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria based on Investigator assessment and computed tomography (CT) scans were commonly used for tumor imaging.
Interventions
- DRUG Niraparib
- DRUG Dostarlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2022-01-12 |
| Phase | Phase 2 |
Why NCT03955471 stopped before completion
NCT03955471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Niraparib is the first listed.
NCT03955471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03955471 about?
NCT03955471 is a clinical study titled "Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer". This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast ca...
What is the current status of trial NCT03955471?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2019-10-03. Estimated completion is 2022-01-12.
What interventions are being tested in trial NCT03955471?
The interventions under investigation include: Niraparib (DRUG), Dostarlimab (DRUG).
Who is sponsoring clinical trial NCT03955471?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03955471's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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