Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)

NCT03776136 on ClinicalTrials.gov Phase 2 Merck Sharp & Dohme LLC (industry) Started 2019-01-30 Completed

Riskier than 78% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 trials).

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

How it ended

Completed on 2023-10-11, after 2019-01-30 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 2023-10-11. 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: cellstagetherapymelanomatransplant
Phrases that lowered it: participantsparticipantefficacydays beforemk
Sponsor's past termination rate: 17.3% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Drug's FAERS reports with a death: 27.2% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 97 (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 1246 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 82.7% (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 7235 (lowers risk) · Drug's FDA history
Collaborators: 1 (raises risk) · Design
Number of arms: 1 (raises 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: 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: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 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: 1246 (typical: 32)
Sponsor's past termination rate: 17.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 97 (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: 17925 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 7235 (typical: 412.5)
Drug's FAERS reports marked serious: 82.7% (typical: 85.6%)
Drug's FAERS reports with a death: 27.2% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: lenvatinib, 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

Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) NCT03820986 · started 2019 · scored riskier than 69% of active trials completed
Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) NCT04305054 · started 2020 · scored riskier than 68% of active trials completed
Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study NCT04889118 · started 2020 · scored riskier than 72% of active trials completed
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) [MK-7902-007/E7080-G000-314/LEAP-007] - China Extension Study NCT04676412 · started 2019 · scored riskier than 72% of active trials completed
Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) NCT04305041 · started 2020 · scored riskier than 68% 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.