Spots Global Cancer Trial Database for Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)
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Trial Identification
Brief Title: Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)
Official Title: A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors
Study ID: NCT03564691
Conditions
Study Description
Brief Summary: This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California at San Francisco ( Site 0004), San Francisco, California, United States
Henry Ford Health System ( Site 0002), Detroit, Michigan, United States
Washington University ( Site 0003), Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005), Hackensack, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0008), New York, New York, United States
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 00, Columbus, Ohio, United States
South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001), San Antonio, Texas, United States
Utah Cancer Specialists ( Site 0011), Salt Lake City, Utah, United States
Seattle Cancer Care Alliance ( Site 0010), Seattle, Washington, United States
Liverpool Hospital-Medical Oncology ( Site 0250), Liverpool, New South Wales, Australia
Princess Alexandra Hospital ( Site 0253), Brisbane, Queensland, Australia
Juravinski Cancer Centre ( Site 0034), Hamilton, Ontario, Canada
The Ottawa Hospital ( Site 0031), Ottawa, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0033), Toronto, Ontario, Canada
The First Hospital of Jilin University ( Site 0803), Changchun, Jilin, China
Shanghai Chest Hospital-Oncology department ( Site 0801), Shanghai, Shanghai, China
West China Hospital of Sichuan University ( Site 0804), Chengdu, Sichuan, China
Hôpital Européen Georges Pompidou ( Site 2003), Paris, Ile-de-France, France
Centre Oscar Lambret ( Site 2002), Lille, Nord, France
Centre Hospitalier Universitaire de Poitiers ( Site 2000), Poitiers, Vienne, France
University General Hospital of Heraklion ( Site 0110), Heraklion, Irakleio, Greece
Euromedica General Clinic of Thessaloniki-Oncology Unit ( Site 0112), Thessaloniki, , Greece
European Interbalkan Medical Center ( Site 0111), Thessaloniki, , Greece
Rambam Health Care Campus-Oncology Division ( Site 0042), Haifa, , Israel
Rabin Medical Center ( Site 0043), Petah Tikva, , Israel
Chaim Sheba Medical Center. ( Site 0044), Ramat Gan, , Israel
Sourasky Medical Center ( Site 0041), Tel Aviv, , Israel
National Cancer Center Hospital East ( Site 0400), Kashiwa, Chiba, Japan
Japanese Foundation for Cancer Research ( Site 0401), Tokyo, , Japan
Severance Hospital Yonsei University Health System ( Site 0300), Seoul, , Korea, Republic of
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0151), Gdansk, Pomorskie, Poland
Wits Clinical Research ( Site 0213), Johannesburg, Gauteng, South Africa
The Oncology Centre ( Site 0212), Durban, Kwazulu-Natal, South Africa
Cancercare Rondebosch Oncology ( Site 0210), Cape Town, Western Cape, South Africa
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0101), Hospitalet de Llobregat, Barcelona, Spain
Centro Integral Oncologico Clara Campal START Madrid ( Site 0102), Madrid, , Spain
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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