Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers
Model scores of the 29,894 trials active now.
Model score 19% 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 (376 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-12-31, after 2019-06-05 start.
Reason given by the sponsor: “enrollment”
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 2022-12-31. 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: carcinomaheartequal tocancerhours
Phrases that lowered it: participantsdayliverinvestigatemg -
Sponsor's past termination rate: 18.4% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 174 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 19.7% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 76.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 130131 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 25193 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Disease area, dermatology: No (lowers risk) · Disease area
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
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 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
- government (typical: academic or other)
- Sponsor's past trials
- 1220 (typical: 32)
- Sponsor's past termination rate
- 18.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 174 (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
- 130131 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 25193 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, endocrine
- Drugs matched to FDA substances
- nivolumab, tadalafil, vancomycin
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
- Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy NCT03302247 · started 2018 · scored riskier than 98% of active trials terminated
- VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC) NCT04166383 · started 2020 · scored riskier than 83% of active trials terminated
- Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC) NCT04057365 · started 2019 · scored riskier than 99% of active trials terminated
- Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma NCT03274258 · started 2018 · scored riskier than 75% of active trials terminated
- Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies NCT04214418 · started 2020 · scored riskier than 90% of active trials terminated
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.