A Study of Intratumoral/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies (V938-001)

NCT04135352 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2019-11-04 Terminated

Riskier than 31% of active trials

Model scores of the 29,894 trials active now.

Model score 13% 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 (1,938 trials).

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

How it ended

Terminated on 2022-08-24, after 2019-11-04 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 2022-08-24. 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
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cancercmhepatitisin situbiopsy
Phrases that lowered it: participantsparticipantvaccinecombinationhiv infected
Drug's FAERS reports with a death: 27.9% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 124 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor's past trials: 1263 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Number of arms: 9 (lowers risk) · Design
Drug's FAERS reports marked serious: 83.4% (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
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: 9 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (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: 1263 (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: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 18710 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 6140 (typical: 412.5)
Drug's FAERS reports marked serious: 83.4% (typical: 85.6%)
Drug's FAERS reports with a death: 27.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer
Drugs matched to FDA substances: 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

Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001) NCT03010176 · started 2017 · scored riskier than 51% of active trials completed
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) NCT03948763 · started 2019 · scored riskier than 31% of active trials terminated
A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101) NCT05708950 · started 2023 · scored riskier than 67% of active trials completed
Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001) NCT03249792 · started 2017 · scored riskier than 42% of active trials terminated
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors NCT05572684 · started 2022 · scored riskier than 37% of active trials terminated

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.