A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)

NCT04153565 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2019-12-09 Completed

Riskier than 28% of active trials

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 2% 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

Completed on 2022-09-21, after 2019-12-09 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 2022-09-21. 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

Sponsor's past termination rate: 17.2% (raises risk) · Sponsor's track record
Minimum age: 20 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 124 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 23.2% (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor's past trials: 1265 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: celllungradiationeligibletherapy
Phrases that lowered it: participantsparticipantvaccineevaluate theto evaluate
Drug's FAERS reports in the prior 12 months: 13679 (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 92.4% (raises risk) · Drug's FDA history
Drug's FAERS reports before start: 80498 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers 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: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 20 (typical: 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: 1265 (typical: 32)
Sponsor's past termination rate: 17.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 124 (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: 80498 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13679 (typical: 412.5)
Drug's FAERS reports marked serious: 92.4% (typical: 85.6%)
Drug's FAERS reports with a death: 23.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer
Drugs matched to FDA substances: cisplatin, pembrolizumab, pemetrexed

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 Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma NCT02991482 · started 2017 · scored riskier than 60% of active trials completed
Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma NCT04166734 · started 2021 · scored riskier than 71% of active trials terminated
Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study NCT03950674 · started 2016 · scored riskier than 45% of active trials completed
KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B) NCT04165083 · started 2019 · scored riskier than 67% of active trials completed
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM NCT05918107 · started 2022 · scored riskier than 36% 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.