Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)

NCT02853331 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2016-09-16 Completed

Riskier than 50% of active trials

Model scores of the 29,894 trials active now.

Model score 17% 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

Completed on 2025-12-26, after 2016-09-16 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 2025-12-26. 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: 16.9% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: randomizationcarcinomaheartcancerprior
Phrases that lowered it: participantsand safetyefficacy andsafety ofevaluate
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 30.0% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 110 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Drug's FAERS reports marked serious: 77.4% (lowers risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 6543 (lowers risk) · Drug's FDA history
Sponsor's past trials: 1157 (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: 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: 7 (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: 1157 (typical: 32)
Sponsor's past termination rate: 16.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 110 (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: 33964 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 6543 (typical: 412.5)
Drug's FAERS reports marked serious: 77.4% (typical: 85.6%)
Drug's FAERS reports with a death: 30.0% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: axitinib, pembrolizumab, sunitinib

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 Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) NCT02853344 · started 2016 · scored riskier than 62% of active trials completed
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) NCT04626518 · started 2020 · scored riskier than 69% of active trials completed
Study in Which Therapy is Either Switched to Nivolumab After 3 Months of Treatment or Therapy is Continued With a Tyrosine Kinase Inhibitor in Patients With Metastatic Renal Cell Carcinoma (RCC) and Disease Control NCT02959554 · started 2016 · scored riskier than 89% of active trials terminated
Intermittent Therapy in Metastatic Renal Cell Carcinoma Patients Treated With Ipilimumab and Nivolumab NCT03126331 · started 2017 · scored riskier than 86% of active trials completed
Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer NCT04394975 · started 2020 · scored riskier than 57% 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.