An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread
Model scores of the 29,894 trials active now.
Model score 23% 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 (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-06-24, after 2016-02-22 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 2021-06-24. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancerpriortreatment forof carestandard of
Phrases that lowered it: subjectsopen labelan opendoseadvanced or -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 10.3% (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 29.1% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 106 (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Drug's FAERS reports before start: 3245 (raises risk) · Drug's FDA history
-
Collaborators: 0 (raises risk) · Design
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
- 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
- 515 (typical: 32)
- Sponsor's past termination rate
- 10.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 106 (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
- 3245 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2951 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- 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
- A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors NCT01928394 · started 2013 · scored riskier than 32% of active trials completed
- Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer NCT03090737 · started 2017 · scored riskier than 31% of active trials completed
- A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen NCT02066636 · started 2014 · scored riskier than 29% of active trials completed
- Nivo/Ipi Combination Therapy in Symptomatic Brain Metastases NCT02621515 · started 2016 · scored riskier than 95% of active trials terminated
- Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC NCT03425331 · started 2018 · scored riskier than 98% 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.