Spots Global Cancer Trial Database for KEYMAKER-U01 Substudy 1: Efficacy and Safety Study of Pembrolizumab (MK-3475) Plus Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
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Trial Identification
Brief Title: KEYMAKER-U01 Substudy 1: Efficacy and Safety Study of Pembrolizumab (MK-3475) Plus Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Official Title: KEYMAKER-U01 Substudy 1: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab in Combination With Chemotherapy in Treatment-Naive Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT04165070
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) PLUS chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, or MK-0482 in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Detailed Description: The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
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 ( 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
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C, 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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