Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
Model scores of the 29,894 trials active now.
Model score 31% for any early termination, 15% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-03-07, after 2018-07-13 start.
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 2024-03-07. 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: celltransplantsolidcancerlung
Phrases that lowered it: psoriasisadministrationaminotransferase10topical -
Sponsor's past termination rate: 75% (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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Responsible party: sponsor investigator (raises risk) · Design
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Drug's FAERS reports with a death: 26.3% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 94.0% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 18810 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Collaborators: 2 (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Blinding: none (raises risk) · Design
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Drug's FAERS reports before start: 87484 (lowers risk) · Drug's FDA history
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
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 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
- academic or other
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 75% (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
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 87484 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18810 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- cisplatin, 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
- 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
- Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer NCT03532451 · started 2019 · scored riskier than 90% of active trials completed
- Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer NCT03518320 · started 2019 · scored riskier than 81% of active trials terminated
- Phase 2 Study of Pembrolizumab in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy NCT02690558 · started 2016 · scored riskier than 95% 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.