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Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

NCT04646005 on ClinicalTrials.gov Phase 2 Regeneron Pharmaceuticals (industry) Started 2021-06-28 Completed
Riskier than 75% of active trials
this trial: 21% 0% 36%

Model scores of the 29,894 trials active now.

Model score 21% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).

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

How it ended

Completed on 2024-05-29, after 2021-06-28 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

0% 18% 35% 53% 70% 0123456 yr completed 61% terminated 26%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-05-29. 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

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
1 (typical: 2)
Allocation
not applicable (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
1 (typical: 0)
Keywords listed
5 (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
136 (typical: 32)
Sponsor's past termination rate
11.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
40 (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
674 (typical: 2148)
Drug's FAERS reports in the prior 12 months
246 (typical: 412.5)
Drug's FAERS reports marked serious
89.2% (typical: 85.6%)
Drug's FAERS reports with a death
19.6% (typical: 15.9%)

Disease area and drugs

Disease areas
cancer, urogenital
Drugs matched to FDA substances
cemiplimab

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

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.