Spots Global Cancer Trial Database for KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
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Trial Identification
Brief Title: KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
Official Title: KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents With Either Pembrolizumab in Combination With Chemotherapy or With Pembrolizumab Alone in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT04165798
Conditions
Study Description
Brief 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 three substudies. Each substudy will enroll a different population of NSCLC participants. The goal of this umbrella master protocol is to screen potential participants with NSCLC for enrollment into 1 of 4 substudies. Participants must first enroll in this pembrolizumab master protocol study and undergo screening for NSCLC that will be used to assign them to participation in 1 of 4 pembrolizumab substudies.
Detailed Description: The following 4 pembrolizumab substudies will evaluate the efficacy of different investigational agents in combination with pembrolizumab given in sequence or in combination with pembrolizumab PLUS chemotherapy: * KEYMAKER-U01 Substudy 1: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with Pembrolizumab in Combination with Chemotherapy in Treatment-Naïve Patients with Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A) - NCT04165070 * 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) (MK-3475-01B) - NCT04165083 * KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated with anti-PD-(L)1 Therapy (MK-3475-01C) - NCT04165096 * KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E) - NCT number pending
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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 ( 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), Gyor, Gyor-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060), Budapest, , Hungary
Soroka Medical Center ( Site 0072), Beer-Sheva, , 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
Policlinico Gemelli di Roma ( Site 0174), Roma, Lazio, Italy
IRCCS Ospedale San Raffaele ( Site 0171), Milano, , Italy
Seoul National University Bundang Hospital ( Site 0081), Seongnam-si, Kyonggi-do, Korea, Republic of
Severance Hospital ( Site 0080), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0082), Seoul, , Korea, Republic of
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150), Gdańsk, Pomorskie, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152), Koszalin, Zachodniopomorskie, Poland
ICO L Hospitalet ( Site 0090), Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Quiron Madrid ( Site 0091), Pozuelo de Alarcon, Madrid, Spain
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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