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NCT04165096 · ClinicalTrials.gov registry record · Phase 2
KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT04165096: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04165096 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04165096, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced squamous or non-squamous NSCLC that have been previously treated with anti-PD-L1 therapy. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Primary Outcome
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-4830
- DRUG acetaminophen
- DRUG diphenhydramine
- BIOLOGICAL Boserolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2025-05-28 |
| Phase | Phase 2 |
What the finished NCT04165096 record still lists
NCT04165096 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04165096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04165096 about?
NCT04165096 is a clinical study titled "KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)". The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced squamous or non-squamous NSCLC that have been previously treated with anti-PD-L1 therapy. This study is one of three pe...
What is the current status of trial NCT04165096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2020-01-21. Estimated completion is 2025-05-28.
What interventions are being tested in trial NCT04165096?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-4830 (BIOLOGICAL), acetaminophen (DRUG), diphenhydramine (DRUG), Boserolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04165096?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04165096's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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