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KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Sponsor: Merck Sharp & Dohme LLC
Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Official title: KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2019-12-19
Completion Date
2032-02-13
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
IV infusion
Carboplatin
IV infusion
Paclitaxel
IV infusion
Pemetrexed
IV infusion
Vibostolimab
IV infusion
Boserolimab
IV infusion
MK-4830
IV infusion
MK-0482
IV Infusion
Ifinatamab Deruxtecan (I-DXd)
IV infusion
HER3-DXd
IV Infusion
Locations (46)
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 ( 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
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( 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 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 On-Surgery department #2 ( 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