Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer

NCT02866006 on ClinicalTrials.gov Phase 1/2 Cellid Co., Ltd. (industry) Started 2016-10-31 Completed

Riskier than 48% of active trials

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 trials).

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

How it ended

Completed on 2022-06-30, after 2016-10-31 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 2022-06-30. 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: cancerbreastbrainulntherapy
Phrases that lowered it: multiplevaccinetypeefficacyadministered
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 20 (lowers risk) · Who can join
Phase: 1/2 (raises risk) · Design
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 28.6% (raises risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Responsible party: sponsor (lowers risk) · Design
Drug's FAERS reports marked serious: 91.2% (raises risk) · Drug's FDA history
Drug's FAERS reports before start: 3168 (raises 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: 1/2 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 20 (typical: 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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (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: 3168 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 456 (typical: 412.5)
Drug's FAERS reports marked serious: 91.2% (typical: 85.6%)
Drug's FAERS reports with a death: 28.6% (typical: 15.9%)

Disease area and drugs

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

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

Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer NCT04405349 · started 2020 · scored riskier than 47% of active trials completed
Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer NCT02865135 · started 2017 · scored riskier than 92% of active trials completed
An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3) NCT02529930 · started 2015 · scored riskier than 52% of active trials completed
Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care NCT03425773 · started 2018 · scored riskier than 17% of active trials completed
Study of the Therapeutic Vaccine (ISA101/ISA101b) to Treat Advanced or Recurrent Cervical Cancer NCT02128126 · started 2013 · scored riskier than 81% 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.