Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-12-11, after 2019-01-02 start.
Reason given by the sponsor: “business”
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 2019-12-11. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjects withheartriskfailuresubject
Phrases that lowered it: participantshcvhepatitis virusscreeningbladder -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 29.2% (raises risk) · Drug's FDA history
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Has a data monitoring committee: not given (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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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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Drug's FAERS reports marked serious: 92.4% (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 14721 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports before start: 56499 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 1 (raises risk) · Sponsor's track record
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Responsible party: sponsor (lowers risk) · Design
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Collaborators: 1 (raises risk) · Design
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
- 1 (typical: 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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 56499 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 14721 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- gemcitabine, nivolumab
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
- Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG Immunotherapy NCT03106610 · started 2017 · scored riskier than 72% of active trials terminated
- Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer NCT02722538 · started 2016 · scored riskier than 76% of active trials completed
- Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing NCT03558087 · started 2018 · scored riskier than 98% of active trials completed
- BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy NCT03294304 · started 2018 · scored riskier than 97% of active trials completed
- Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo NCT03421652 · started 2018 · scored riskier than 98% 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.