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)
Public ClinicalTrials.gov record NCT04165096. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Anti-PD-(L)1 Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04165096
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Boserolimab Biological
- MK-4830 Biological
- diphenhydramine Drug
- acetaminophen Drug
- MK-0482 Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 21, 2020 (Actual)
- Primary completion
- Apr 30, 2025 (Actual)
- Completion
- May 28, 2025 (Actual)
- Last update posted
- Jun 26, 2026
2020 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0001) | Gilbert | Arizona | 85234 | — |
| City of Hope ( Site 0014) | Duarte | California | 91010 | — |
| UCSF Medical Center at Mission Bay ( Site 0007) | San Francisco | California | 94158 | — |
| Georgetown University ( Site 0036) | Washington D.C. | District of Columbia | 20007 | — |
| University of Kentucky Markey Cancer Center ( Site 0019) | Lexington | Kentucky | 40536-0293 | — |
| MedStar Franklin Square Medical Center ( Site 0033) | Baltimore | Maryland | 21237 | — |
| Massachusetts General Hospital ( Site 0003) | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute ( Site 0002) | Boston | Massachusetts | 02215 | — |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) | Omaha | Nebraska | 68130 | — |
| Dartmouth Hitchcock Medical Center ( Site 0016) | Lebanon | New Hampshire | 03766 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) | Hackensack | New Jersey | 07601 | — |
| Laura and Isaac Perlmutter Cancer Center ( Site 0034) | New York | New York | 10016 | — |
| Sanford Fargo Medical Center ( Site 0039) | Fargo | North Dakota | 58102 | — |
| Cleveland Clinic Main ( Site 0006) | Cleveland | Ohio | 44195 | — |
| Ohio State University Comprehensive Cancer Center ( Site 0015) | Columbus | Ohio | 43210 | — |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0010) | Philadelphia | Pennsylvania | 19104 | — |
| Sanford Cancer Center ( Site 0038) | Sioux Falls | South Dakota | 57104 | — |
| The University of Texas MD Anderson Cancer Center ( Site 0009) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04165096, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04165096 live on ClinicalTrials.gov.