Clinical Research Directory
Browse clinical research sites, groups, and studies.
KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
Sponsor: Merck Sharp & Dohme LLC
Summary
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.
Official title: KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1065
Start Date
2019-12-19
Completion Date
2032-02-13
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Tumor Imaging
Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
Tumor Tissue Collection
Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.
Blood Sample Collection
Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)
Locations (47)
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
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel
Chaim Sheba Medical Center ( Site 0070)
Ramat Gan, Israel
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Firenze, Italy
IRCCS Ospedale San Raffaele ( Site 0171)
Milan, Italy
Policlinico Gemelli di Roma ( Site 0174)
Roma, Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Bundang Hospital ( Site 0081)
Seongnam-si, Kyonggi-do, South Korea
Severance Hospital ( Site 0080)
Seoul, South Korea
Samsung Medical Center ( Site 0082)
Seoul, South Korea
ICO L Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clínic de Barcelona ( Site 0092)
Barcelona, Spain
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain
Changhua Christian Hospital ( Site 0181)
Changhua, Taiwan
Taipei Medical University Hospital ( Site 0180)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)
Taoyuan District, Taiwan
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)
Cherkasy, Cherkasy Oblast, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)
Rivne, Rivne Oblast, Ukraine
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)
Uzhhorod, Zakarpattia Oblast, Ukraine