A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)

NCT05311176 on ClinicalTrials.gov Phase 2 Imugene Limited (industry) Started 2022-08-17 Terminated

Riskier than 84% of active trials

Model scores of the 29,894 trials active now.

Model score 23% for any early termination, 7% 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

Terminated on 2024-04-04, after 2022-08-17 start.

Reason given by the sponsor: “enrollment”

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 2024-04-04. 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: cellher2carcinomatrastuzumabradiation
Phrases that lowered it: open labellungarmdiseasesgastric
Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports with a death: 20.4% (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Number of arms: 2 (raises risk) · Design
Blinding: none (raises risk) · Design
Drug's FAERS reports marked serious: 91.0% (raises risk) · Drug's FDA history
Collaborators: 0 (raises risk) · Design
Sponsor's past trials: 0 (raises risk) · Sponsor's track record

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: 2
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (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: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 121753 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 19976 (typical: 412.5)
Drug's FAERS reports marked serious: 91.0% (typical: 85.6%)
Drug's FAERS reports with a death: 20.4% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: paclitaxel, pembrolizumab, ramucirumab

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

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811) NCT03615326 · started 2018 · scored riskier than 41% of active trials completed
A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer NCT02795988 · started 2017 · scored riskier than 67% of active trials completed
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer NCT05027139 · started 2021 · scored riskier than 99% of active trials completed
Trastuzumab Therapy in Non-Small Cell Lung Cancer Patients NCT00758134 · started 2008 · scored riskier than 97% of active trials terminated
Two-Part, Phase Ib/II, Open Label, Single-Arm, Multi-center Study to Evaluate the Safety and Efficacy of Varlitinib in Combination With Weekly Paclitaxel in EGFR/HER2 Co-expressing Advanced or Metastatic Gastric Cancer Patients NCT05400915 · started 2019 · scored riskier than 54% 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.