IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors

NCT03665129 on ClinicalTrials.gov Phase 1 Innate Pharma (industry) Started 2018-09-07 Terminated

Riskier than 28% of active trials

Model scores of the 29,894 trials active now.

Model score 13% 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

Terminated on 2021-02-24, after 2018-09-07 start.

Reason given by the sponsor: “other”

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 2021-02-24. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 24.8% (raises risk) · Drug's FDA history
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cell lungsmall celllung cancernon smallnsclc
Phrases that lowered it: open labelevaluate thehepaticto evaluatebleeding
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 93.7% (raises risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Collaborators: 1 (raises risk) · Design
Design: sequential (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: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 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: 8 (typical: 32)
Sponsor's past termination rate: 12.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (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: 1666 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1121 (typical: 412.5)
Drug's FAERS reports marked serious: 93.7% (typical: 85.6%)
Drug's FAERS reports with a death: 24.8% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: durvalumab

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

IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors. NCT04261075 · started 2020 · scored riskier than 32% of active trials completed
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203) NCT02318277 · started 2015 · scored riskier than 97% of active trials completed
A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors NCT05864144 · started 2023 · scored riskier than 92% of active trials completed
A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) NCT02554812 · started 2015 · scored riskier than 92% of active trials terminated
A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors NCT04731467 · started 2021 · scored riskier than 97% 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.