Phase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Breast Cancer
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-05-11, after 2018-01-21 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 2022-05-11. 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: metastaticdose ofrandomizationcancercell
Phrases that lowered it: influenzapaineffect ofthe effectarthritis -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Collaborators: 7 (lowers risk) · Design
-
Sponsor's past termination rate: 6.0% (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 62 (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Sponsor's past trials: 168 (lowers risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: 24.8% (raises risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Drug's FAERS reports marked serious: 92.6% (raises risk) · Drug's FDA history
-
Drug's FAERS reports in the prior 12 months: 31674 (lowers risk) · Drug's FDA history
-
Drugs with FDA adverse-event history: 4 (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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 7 (typical: 0)
- Keywords listed
- 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
- academic or other
- Sponsor's past trials
- 168 (typical: 32)
- Sponsor's past termination rate
- 6.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 62 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 144833 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 31674 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- cyclophosphamide, doxorubicin, 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
- Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer NCT03164993 · started 2017 · scored riskier than 71% of active trials completed
- Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC NCT04081688 · started 2019 · scored riskier than 94% of active trials terminated
- Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer NCT03414684 · started 2018 · scored riskier than 87% of active trials completed
- IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC NCT05077709 · started 2022 · scored riskier than 60% of active trials completed
- Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease NCT03095352 · started 2017 · scored riskier than 63% 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.