Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2012-10-31, after 2009-08-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-10-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: melanomaadvancedbrainipilimumabmeasurable
Phrases that lowered it: pharmacokineticscompareocularlabelparallel -
Phase: 1 (lowers risk) · Design
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Drug's FAERS reports with a death: 36.4% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 116 (lowers risk) · Sponsor's track record
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Design: parallel (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
-
Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports before start: 22 (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (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
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 196 (typical: 32)
- Sponsor's past termination rate
- 7.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 116 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 22 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 36.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ipilimumab
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
- Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine NCT00796991 · started 2009 · scored riskier than 28% of active trials completed
- Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients NCT01990859 · started 2013 · scored riskier than 39% of active trials completed
- Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma NCT01024231 · started 2009 · scored riskier than 44% of active trials completed
- Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab NCT01515189 · started 2012 · scored riskier than 61% of active trials completed
- A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma NCT05907122 · started 2023 · scored riskier than 59% 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.