A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

NCT04340193 on ClinicalTrials.gov Phase 3 Bristol-Myers Squibb (industry) Started 2020-09-14 Completed

Riskier than 58% of active trials

Model scores of the 29,894 trials active now.

Model score 18% 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 (927 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2023-12-12, after 2020-09-14 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 2023-12-12. 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: stageipilimumabcancertumoroncology
Phrases that lowered it: participantparticipantsevaluate theto evaluateknown or
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Sponsor's past termination rate: 10.3% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 27.3% (raises risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 85 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Sponsor's past trials: 715 (raises risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 13023 (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 70891 (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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (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: 715 (typical: 32)
Sponsor's past termination rate: 10.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 85 (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: 70891 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13023 (typical: 412.5)
Drug's FAERS reports marked serious: 88.9% (typical: 85.6%)
Drug's FAERS reports with a death: 27.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: 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

Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib NCT01352728 · started 2011 · scored riskier than 84% of active trials completed
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma NCT04039607 · started 2019 · scored riskier than 60% of active trials completed
Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012) NCT04246177 · started 2020 · scored riskier than 66% of active trials terminated
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma NCT02576509 · started 2015 · scored riskier than 71% of active trials completed
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC) NCT00618384 · started 2008 · scored riskier than 47% 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.