Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted
Model scores of the 29,894 trials active now.
Model score 17% 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 23% of the time (1,629 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-05-17, after 2019-07-10 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 2023-05-17. 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: cancercellscelltherapyconcurrent
Phrases that lowered it: patientsvisitdrugmaleaminotransferase -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports with a death: 27.8% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 9.2% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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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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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 27 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 15892 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports before start: 56017 (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 3 (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
- 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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- academic or other
- Sponsor's past trials
- 109 (typical: 32)
- Sponsor's past termination rate
- 9.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 27 (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
- 56017 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 15892 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- ipilimumab, nivolumab, talimogene laherparepvec
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
- Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery NCT02658812 · started 2016 · scored riskier than 83% of active trials terminated
- T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer NCT03554044 · started 2020 · scored riskier than 35% of active trials completed
- Study of TVEC in Patients With Cutaneous Squamous Cell Cancer NCT03714828 · started 2018 · scored riskier than 91% of active trials completed
- Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin NCT04163952 · started 2020 · scored riskier than 83% of active trials terminated
- Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma NCT03921073 · started 2019 · scored riskier than 74% 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.