Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-01-12, after 2019-10-03 start.
Reason given by the sponsor: “efficacy”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-01-12. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Sponsor's past termination rate: 18.2% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 8.8% (lowers risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancerchemotherapyleukemiatherapymyeloid
Phrases that lowered it: participantparticipantsand safetyefficacy andevaluate -
Design: single group (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 70.0% (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 11 (typical: 32)
- Sponsor's past termination rate
- 18.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 5542 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2624 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital, endocrine
- Drugs matched to FDA substances
- dostarlimab, niraparib
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants NCT03308942 · started 2017 · scored riskier than 78% of active trials completed
- A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy NCT03326193 · started 2017 · scored riskier than 98% of active trials completed
- Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer NCT02657889 · started 2016 · scored riskier than 99% of active trials completed
- Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer NCT03759600 · started 2018 · scored riskier than 34% of active trials completed
- A Study of Niraparib in Patients With Relapsed Ovarian Cancer NCT04392102 · started 2020 · scored riskier than 90% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.