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)
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Procedure, Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
• Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
Locations
United States
Arizona
Banner MD Anderson Cancer Center ( Site 0001)
COMPLETED
Gilbert
California
City of Hope ( Site 0014)
COMPLETED
Duarte
UCSF Medical Center at Mission Bay ( Site 0007)
COMPLETED
San Francisco
Washington, D.c.
Georgetown University ( Site 0036)
COMPLETED
Washington D.c.
Kentucky
University of Kentucky Markey Cancer Center ( Site 0019)
COMPLETED
Lexington
Massachusetts
Dana Farber Cancer Institute ( Site 0002)
COMPLETED
Boston
Massachusetts General Hospital ( Site 0003)
COMPLETED
Boston
Maryland
MedStar Franklin Square Medical Center ( Site 0033)
COMPLETED
Baltimore
North Dakota
Sanford Fargo Medical Center ( Site 0039)
RECRUITING
Fargo
Nebraska
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
COMPLETED
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center ( Site 0016)
RECRUITING
Lebanon
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
COMPLETED
Hackensack
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)
COMPLETED
New York
Ohio
Cleveland Clinic Main ( Site 0006)
COMPLETED
Cleveland
Ohio State University Comprehensive Cancer Center ( Site 0015)
RECRUITING
Columbus
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
RECRUITING
Philadelphia
South Dakota
Sanford Cancer Center ( Site 0038)
RECRUITING
Sioux Falls
Texas
The University of Texas MD Anderson Cancer Center ( Site 0009)
RECRUITING
Houston
Other Locations
Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)
COMPLETED
Budapest
Petz Aladar Megyei Oktato Korhaz ( Site 0062)
COMPLETED
Győr
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)
COMPLETED
Szolnok
Israel
Soroka Medical Center ( Site 0072)
COMPLETED
Beersheba
Rambam Health Care Campus-Oncology ( Site 0076)
COMPLETED
Haifa
Shaare Zedek Medical Center ( Site 0075)
RECRUITING
Jerusalem
Meir Medical Center ( Site 0071)
COMPLETED
Kfar Saba
Rabin Medical Center ( Site 0074)
COMPLETED
Petah Tikva
Chaim Sheba Medical Center ( Site 0070)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 0077)
COMPLETED
Tel Aviv
Italy
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
COMPLETED
Florence
IRCCS Ospedale San Raffaele ( Site 0171)
COMPLETED
Milan
Policlinico Gemelli di Roma ( Site 0174)
COMPLETED
Roma
Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
RECRUITING
Gdansk
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
ACTIVE_NOT_RECRUITING
Koszalin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
RECRUITING
Warsaw
Republic of Korea
Seoul National University Bundang Hospital ( Site 0081)
COMPLETED
Seongnam-si
Samsung Medical Center ( Site 0082)
COMPLETED
Seoul
Severance Hospital ( Site 0080)
COMPLETED
Seoul
Spain
Hospital Clínic de Barcelona ( Site 0092)
RECRUITING
Barcelona
ICO L Hospitalet ( Site 0090)
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Quiron Madrid ( Site 0091)
RECRUITING
Madrid
Taiwan
Changhua Christian Hospital ( Site 0181)
RECRUITING
Changhua
Taipei Medical University Hospital ( Site 0180)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)
RECRUITING
Taoyuan District
Ukraine
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)
RECRUITING
Cherkasy
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Reg ( Site 0460)
RECRUITING
Ivano-frankivsk
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)
RECRUITING
Rivne
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)
RECRUITING
Uzhhorod
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2019-12-19
Estimated Completion Date: 2032-02-13
Participants
Target number of participants: 1065
Treatments
Prospective NSCLC Participants
Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC will be screened for participation in 1 of several pembrolizumab substudies.
Related Therapeutic Areas
Sponsors
Collaborators: Daiichi Sankyo
Leads: Merck Sharp & Dohme LLC