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An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

NCT03956680 on ClinicalTrials.gov Phase 1 Bristol-Myers Squibb (industry) Started 2019-03-26 Completed
Riskier than 50% of active trials
this trial: 16% 0% 36%

Model scores of the 29,894 trials active now.

Model score 16% 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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-04-24, after 2019-03-26 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

0% 13% 26% 39% 52% 0123456 yr completed 46% terminated 19%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-04-24. 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

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
5 (typical: 2)
Allocation
not applicable (typical: randomized)
Design
sequential (typical: parallel)
Primary purpose
treatment
Blinding
none
Has a data monitoring committee
No (typical: 56% yes)
Responsible party
sponsor
Collaborators
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
645 (typical: 32)
Sponsor's past termination rate
10.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
108 (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
49885 (typical: 2148)
Drug's FAERS reports in the prior 12 months
15209 (typical: 412.5)
Drug's FAERS reports marked serious
87.6% (typical: 85.6%)
Drug's FAERS reports with a death
28.3% (typical: 15.9%)

Disease area and drugs

Disease areas
none of the 14 tracked areas
Drugs matched to FDA substances
bms986301, ipilimumab, 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

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.