Study of Upifitamab Rilsodotin in Combination With Carboplatin in Participants With High-grade Serous Ovarian Cancer

NCT04907968 on ClinicalTrials.gov Phase 1 Mersana Therapeutics (industry) Started 2021-06-11 Terminated

Riskier than 27% of active trials

Model scores of the 29,894 trials active now.

Model score 13% 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 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 2023-10-03, after 2021-06-11 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 2023-10-03. 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: cancertherapygradecellprior
Phrases that lowered it: participantparticipantsthe pharmacokineticspharmacokinetics ofopen label
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Drug's FAERS reports with a death: 17.5% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Collaborators: 2 (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Sponsor's past trials: 3 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Number of arms: 2 (raises risk) · Design
Drug's FAERS reports before start: 71432 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 9207 (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: 1 (typical: 2)
Number of arms: 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: 2 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 3 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 2 (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: 71432 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9207 (typical: 412.5)
Drug's FAERS reports marked serious: 92.2% (typical: 85.6%)
Drug's FAERS reports with a death: 17.5% (typical: 15.9%)

Disease area and drugs

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

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

Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT) NCT05329545 · started 2022 · scored riskier than 60% of active trials terminated
A Study of Pembrolizumab With Standard Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer NCT02608684 · started 2016 · scored riskier than 97% of active trials completed
A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical) NCT03495882 · started 2017 · scored riskier than 68% of active trials completed
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer NCT03104699 · started 2017 · scored riskier than 67% of active trials completed
A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer NCT05200364 · started 2022 · scored riskier than 67% 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.