NCT04165083CompletedPhase 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)
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)
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 14 Nov 2019
- Start date
- 7 Jan 2021
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Lung cancer
- NCT number
- NCT04165083
- EU CT number
- 2023-506933-32-00
- EudraCT number
- 2020-001627-14
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 7 Jan 2021 to the primary completion date, 31 Oct 2025
- 40 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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
- Has had an allogenic tissue/solid organ transplant
Other illness
- Has a diagnosis of small cell lung cancer
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- 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
Other
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- 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
Criteria the registry did not label
- Inclusion:
- Has a histologically- or cytologically-confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC)
- Has non-squamous NSCLC and is not eligible for an approved targeted therapy
- Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation
- Has not received prior systemic treatment for metastatic NSCLC
- Has programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
- Is able to complete all screening procedures within the 35-day screening window.
- Male participants must agree to use contraception and refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment
- Female participants must not be pregnant or breastfeeding, and at least one of the following conditions apply:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to use contraception during the treatment period and for at least 120 days after the last dose of study treatment
- Has adequate organ function within 10 days of initiation of study treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| Koranyi National Institute For Pulmonology Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Completed |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Coordinator of this site? Confirm its status | Szolnok | Hungary | Completed |
| Soroka Medical Center ( Site 0072) Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Rambam Health Care Campus-Oncology ( Site 0076) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center ( Site 0075) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Meir Medical Center ( Site 0071) Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Rabin Medical Center ( Site 0074) Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Chaim Sheba Medical Center ( Site 0070) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Center ( Site 0077) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Seoul National University Bundang Hospital ( Site 0081) Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Severance Hospital ( Site 0080) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center ( Site 0082) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Completed |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| MedStar Franklin Square Medical Center ( Site 0033) Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dana Farber Cancer Institute ( Site 0002) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital ( Site 0003) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Main ( Site 0006) Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center ( Site 0015) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| City of Hope ( Site 0014) Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Sanford Fargo Medical Center ( Site 0039) Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Banner MD Anderson Cancer Center ( Site 0001) Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center ( Site 0009) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Dartmouth Hitchcock Medical Center ( Site 0016) Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Kentucky Markey Cancer Center ( Site 0019) Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0010) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UCSF Medical Center at Mission Bay ( Site 0007) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Sanford Cancer Center ( Site 0038) Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Georgetown University ( Site 0036) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.