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)

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT04165083

Run by

Merck Sharp & Dohme LLC

People needed

102

Starts

2019-12-19

Expected to finish

2025-10-31

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Has a diagnosis of small cell lung cancer
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
• Has an active infection requiring systemic therapy
• Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment, or New York Heart Association Class III or IV congestive heart failure
• Has a known history of Human Immunodeficiency Virus (HIV) infection
• Has a known history of Hepatitis B or known active Hepatitis C virus infection
• Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
• Has had major surgery <3 weeks before the first dose of study treatment
• Has received prior radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study treatment
• Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE)
• Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs)
• Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed
• Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease.
• Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or prior therapy targeting other immuno-regulatory receptors or mechanisms
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment
• Has had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
• Has had an allogenic tissue/solid organ transplant

Where it is running

• Banner MD Anderson Cancer Center ( Site 0001) — Gilbert, Arizona, United States
• City of Hope ( Site 0014) — Duarte, California, United States
• UCSF Medical Center at Mission Bay ( Site 0007) — San Francisco, California, United States
• Georgetown University ( Site 0036) — Washington D.C., District of Columbia, United States
• University of Kentucky Markey Cancer Center ( Site 0019) — Lexington, Kentucky, United States
• MedStar Franklin Square Medical Center ( Site 0033) — Baltimore, Maryland, United States
• Massachusetts General Hospital ( Site 0003) — Boston, Massachusetts, United States
• Dana Farber Cancer Institute ( Site 0002) — Boston, Massachusetts, United States
• Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) — Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center ( Site 0016) — Lebanon, New Hampshire, United States
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) — Hackensack, New Jersey, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034) — New York, New York, United States
• Sanford Fargo Medical Center ( Site 0039) — Fargo, North Dakota, United States
• Cleveland Clinic Main ( Site 0006) — Cleveland, Ohio, United States
• Ohio State University Comprehensive Cancer Center ( Site 0015) — Columbus, Ohio, United States
• Abramson Cancer Center of the University of Pennsylvania ( Site 0010) — Philadelphia, Pennsylvania, United States
• Sanford Cancer Center ( Site 0038) — Sioux Falls, South Dakota, United States
• The University of Texas MD Anderson Cancer Center ( Site 0009) — Houston, Texas, United States
• Petz Aladar Megyei Oktato Korhaz ( Site 0062) — Győr, Győr-Moson-Sopron, Hungary
• Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) — Szolnok, Jász-Nagykun-Szolnok, Hungary
• Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) — Budapest, Hungary
• Soroka Medical Center ( Site 0072) — Beersheba, Israel
• Rambam Health Care Campus-Oncology ( Site 0076) — Haifa, Israel
• Shaare Zedek Medical Center ( Site 0075) — Jerusalem, Israel
• Meir Medical Center ( Site 0071) — Kfar Saba, Israel

Full record on ClinicalTrials.gov

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