Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-02-06, after 2019-01-31 start.
Reason given by the sponsor: “business”
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 2023-02-06. 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: metastatictumorpdtherapyadvanced
Phrases that lowered it: openlabelpatientsefficacy andarm -
Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 45.0% (lowers risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 4.1% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 159 (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
-
Sponsor's past trials: 1191 (raises risk) · Sponsor's track record
-
Number of arms: 4 (lowers risk) · Design
-
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
-
Maximum age: not given (raises risk) · Who can join
-
Responsible party: sponsor (lowers 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
- 1 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- non randomized (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
- 2 (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
- 1191 (typical: 32)
- Sponsor's past termination rate
- 15.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 159 (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
- 5190 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1334 (typical: 412.5)
- Drug's FAERS reports marked serious
- 45.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- canakinumab, capmatinib, pdr001, spartalizumab
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 to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies NCT03719326 · started 2018 · scored riskier than 27% of active trials completed
- Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED NCT05520723 · started 2023 · scored riskier than 93% of active trials completed
- A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer NCT03499899 · started 2018 · scored riskier than 83% of active trials completed
- Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer NCT03164993 · started 2017 · scored riskier than 71% of active trials completed
- Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer NCT02129556 · started 2014 · scored riskier than 86% 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.