Spots Global Cancer Trial Database for A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)
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Trial Identification
Brief Title: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)
Official Title: A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)
Study ID: NCT03516981
Conditions
Study Description
Brief Summary: This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile \[GEP\] and tumor mutational burden \[TMB\]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.
Detailed Description: After Amendment 5, participants can receive 800 mg of favezelimab every 3 weeks (Q3W)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC- HAL ( Site 8001), Tempe, Arizona, United States
University of California Davis Comprehensive Cancer Center ( Site 0137), Sacramento, California, United States
University of California San Francisco ( Site 0111), San Francisco, California, United States
UCLA Hematology/Oncology -Santa Monica ( Site 0108), Santa Monica, California, United States
Yale University School of Medicine ( Site 0100), New Haven, Connecticut, United States
Mayo Clinic Florida ( Site 0115), Jacksonville, Florida, United States
University of Maryland ( Site 0136), Baltimore, Maryland, United States
Mayo Clinic Rochester - St. Mary's Hospital ( Site 0117), Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0112), Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center ( Site 0113), New York, New York, United States
Weill Cornell Medical College ( Site 0138), New York, New York, United States
Oncology Hematology Care ( Site 8005), Cincinnati, Ohio, United States
University of Pennsylvania ( Site 0132), Philadelphia, Pennsylvania, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 0104), Pittsburgh, Pennsylvania, United States
Texas Oncology-Memorial City ( Site 8006), Houston, Texas, United States
Texas Oncology-Tyler ( Site 8003), Tyler, Texas, United States
Emily Couric Clinical Cancer Center ( Site 0134), Charlottesville, Virginia, United States
Northwest Cancer Specialists, P.C. ( Site 8000), Vancouver, Washington, United States
University of Wisconsin- Madison Carbone Cancer Center ( Site 0130), Madison, Wisconsin, United States
Blacktown Hospital Western Sydney Local Health District ( Site 0200), Blacktown, New South Wales, Australia
Gallipoli Medical Research Foundation ( Site 0202), Brisbane, Queensland, Australia
Fiona Stanley Hospital ( Site 0201), Murdoch, Western Australia, Australia
The Ottawa Hospital ( Site 0306), Ottawa, Ontario, Canada
Sunnybrook Health Science Centre ( Site 0304), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0309), Toronto, Ontario, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0305), Chicoutimi, Quebec, Canada
Jewish General Hospital ( Site 0307), Montreal, Quebec, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0310), Montreal, Quebec, Canada
Prince of Wales Hospital ( Site 1801), Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 1800), Hong Kong, , Hong Kong
St James Hospital ( Site 2200), Dublin, , Ireland
Mid Western Cancer Centre ( Site 2201), Limerick, , Ireland
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0702), Meldola, Emilia-Romagna, Italy
Istituto Clinico Humanitas Research Hospital ( Site 0700), Rozzano, Lombardia, Italy
AOU San Luigi Gonzaga di Orbassano ( Site 0707), Orbassano, Torino, Italy
AULSS21 Regione Veneto Ospedale Mater Salutis - Legnago ( Site 0701), Legnago, Verona, Italy
Azienda Ospedaliera Papardo ( Site 0706), Messina, , Italy
Seconda Universita degli Studi di Napoli ( Site 0704), Napoli, , Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 0703), Roma, , Italy
Azienda Ospedaliera Universitaria Senese ( Site 0705), Siena, , Italy
National Cancer Center Hospital ( Site 2001), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 2000), Tokyo, , Japan
Seoul National University Bundang Hospital ( Site 0803), Seongnam-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 0801), Songpa-gu, Seoul, Korea, Republic of
Seoul National University Hospital ( Site 0800), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0802), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0805), Seoul, , Korea, Republic of
Dolnoslaskie Centrum Onkologii. ( Site 0993), Wroclaw, Dolnoslaskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
MED-POLONIA Sp. z o.o. ( Site 0907), Poznan, Wielkopolskie, Poland
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1003), Ufa, Baskortostan, Respublika, Russian Federation
The Loginov Moscow Clinical Scientific Center ( Site 1008), Moscow, Moskva, Russian Federation
N.N. Blokhin NMRCO ( Site 1000), Moscow, Moskva, Russian Federation
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site, Omsk, Omskaya Oblast, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 1001), Saint Petersburg, Sankt-Peterburg, Russian Federation
St Petersburg City Clinical Oncology Dispensary ( Site 1002), St. Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1005), Kazan, Tatarstan, Respublika, Russian Federation
National Cancer Centre Singapore ( Site 1900), Singapore, Central Singapore, Singapore
National University Hospital ( Site 1901), Singapore, South West, Singapore
MPOC ( Site 2310), Groenkloof Pretoria, Gauteng, South Africa
Wits Clinical Research ( Site 2313), Parktown-Johannesburg, Gauteng, South Africa
Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2315), Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 2316), Sandton, Gauteng, South Africa
Vaal Triangle Oncology Centre ( Site 2314), Vereeniging, Gauteng, South Africa
Umhlanga Oncolgy Center ( Site 2311), Umhlanga, Kwazulu-Natal, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 2312), Kraaifontein, Western Cape, South Africa
Hospital General Universitari Vall d Hebron ( Site 1100), Barcelona, , Spain
Hospital Universitario Ramon y Cajal ( Site 1101), Madrid, , Spain
Hospital Universitario 12 de Octubre ( Site 1102), Madrid, , Spain
Kantonsspital St. Gallen ( Site 2102), St. Gallen, Aargau, Switzerland
Universitaetsspital Basel ( Site 2104), Basel, Basel-Stadt, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 2106), Geneva, Geneve, Switzerland
Kantonsspital Graubuenden ( Site 2103), Chur, Grisons, Switzerland
Universitaetsspital Zuerich ( Site 2100), Zuerich, Zurich, Switzerland
Kaohsiung Chang Gung Memorial Hospital ( Site 1203), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 1202), Tainan, , Taiwan
National Taiwan University Hospital ( Site 1200), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1204), Taipei, , Taiwan
Cambridge University Hospitals NHS Trust ( Site 1306), Cambridge, Cambridgeshire, United Kingdom
University College London Hospital NHS Foundation Trust ( Site 1308), London, London, City Of, United Kingdom
Derriford Hospital ( Site 1301), Plymouth, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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