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NCT04165083 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT04165083 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 102 participants.
The verdict
NCT04165083, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). The pembrolizumab+ MK-0482 arm was added with Amendment 6.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-4830
- BIOLOGICAL MK-0482
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2025-10-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04165083
The ClinicalTrials.gov registry entry for NCT04165083 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04165083 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04165083 about?
NCT04165083 is a clinical study titled "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)". The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive. This study is one of three pembrolizumab substudies being conducted under one pe...
What is the current status of trial NCT04165083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2019-12-19. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT04165083?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-4830 (BIOLOGICAL), MK-0482 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04165083?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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