Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)

NCT03019588 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2017-02-16 Terminated

Riskier than 19% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 3% 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 (927 trials).

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

How it ended

Terminated on 2021-06-29, after 2017-02-16 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 2021-06-29. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cancertherapypaclitaxeladenocarcinomabaseline
Phrases that lowered it: participantsvaccinetrialvirusarm
Sponsor's past termination rate: 16.8% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 24.4% (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 1170 (raises risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 8675 (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 93.1% (raises risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join

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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (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: 1170 (typical: 32)
Sponsor's past termination rate: 16.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 100 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 33991 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8675 (typical: 412.5)
Drug's FAERS reports marked serious: 93.1% (typical: 85.6%)
Drug's FAERS reports with a death: 24.4% (typical: 15.9%)

Disease area and drugs

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

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 of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061) NCT02370498 · started 2015 · scored riskier than 20% of active trials completed
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) NCT03221426 · started 2017 · scored riskier than 51% of active trials completed
A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059) NCT02335411 · started 2015 · scored riskier than 60% of active trials completed
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181) NCT02564263 · started 2015 · scored riskier than 21% of active trials completed
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study NCT03933449 · started 2016 · scored riskier than 21% 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.