Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL

NCT02689726 on ClinicalTrials.gov Phase 1 Genticel (industry) Started 2015-08-31 Terminated

Riskier than 6% of active trials

Model scores of the 29,894 trials active now.

Model score 5% 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 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 2016-08-31, after 2015-08-31 start.

Reason given by the sponsor: “efficacy”

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 2016-08-31. 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) (lowers risk) · Wording Phrases that raised it: ulncellsubject iscellsmalignancy
Phrases that lowered it: vaccinevaccinationinfectedimmunogenicityevaluate the
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Minimum age: 25 (lowers risk) · Who can join
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 3.7% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 70.9% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 1 (raises risk) · Design
Collaborators: 1 (raises 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: 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: 0 (typical: 1)

Who can join

Minimum age: 25 (typical: 18)
Maximum age: 65 (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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (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: 481 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 168 (typical: 412.5)
Drug's FAERS reports marked serious: 70.9% (typical: 85.6%)
Drug's FAERS reports with a death: 3.7% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: imiquimod

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 the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213) NCT03493542 · started 2018 · scored riskier than 2% of active trials completed
Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL NCT03911076 · started 2019 · scored riskier than 70% of active trials terminated
Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017) NCT03546842 · started 2018 · scored riskier than 3% of active trials completed
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age NCT05496231 · started 2022 · scored riskier than 2% of active trials completed
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL NCT06276101 · started 2024 · scored riskier than 26% 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.