ClinicalTrials.gov record
Completed Phase 2 Interventional

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)

ClinicalTrials.gov ID: NCT04165083

Public ClinicalTrials.gov record NCT04165083. 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.

ClinicalTrials.gov public records Last synced May 4, 2026, 8:26 AM EDT

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 2: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab in Treatment Naïve Patients With PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC)

Study identification

NCT ID
NCT04165083
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
102 participants

Conditions and interventions

Interventions

  • MK-0482 Biological
  • MK-4830 Biological
  • Pembrolizumab Biological

Biological

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
Dec 18, 2019
Primary completion
Oct 30, 2025
Completion
Oct 30, 2025
Last update posted
Nov 25, 2025

2019 – 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 at NYU Langone Health ( 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 NCT04165083, 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 Nov 25, 2025 · Synced May 4, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04165083 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →