A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90033, United States
Washington D.C., District of Columbia 20010, United States
Washington D.C., District of Columbia 20037, United States
Miami, Florida 33136, United States
Orlando, Florida 32804, United States
Lexington, Kentucky 40536, United States
Worcester, Massachusetts 01655, United States
Edina, Minnesota 55435, United States
Columbia, Missouri 65212, United States
Springfield, Missouri 65804, United States
Basking Ridge, New Jersey 07920, United States
Middletown, New Jersey 07748, United States
Newark, New Jersey 07103, United States
Albuquerque, New Mexico 87131-0001, United States
Commack, New York 11725, United States
Harrison, New York 10604, United States
New York, New York 10016, United States
Uniondale, New York 11553, United States
Winston-Salem, North Carolina 27357, United States
Portland, Oregon 97227, United States
Philadelphia, Pennsylvania 19107, United States
Salt Lake City, Utah 84112-5550, United States
Charlottesville, Virginia 22908, United States
Seattle, Washington 98109, United States
Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina
Ciudad de Buenos Aires, Buenos Aires F.D. C1280AEB, Argentina
Buenos Aires, C1012AAR, Argentina
San Juan, J5402DIL, Argentina
Westmead, New South Wales 2145, Australia
Salvador, Estado de Bahia 40050-410, Brazil
Ipatinga, Minas Gerais 35162-189, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Rio de Janeiro, 20231-050, Brazil
São Paulo, 01321-001, Brazil
Sherbrooke, Quebec J1H 5N4, Canada
Tübingen, Baden-Wurttemberg 72076, Germany
München, Bavaria 81675, Germany
Szolnok, Jász-Nagykun-Szolnok 5004, Hungary
Kita-gun, Kagawa-ken 761-0793, Japan
Krakow, Lesser Poland Voivodeship 31-826, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Gliwice, Silesian Voivodeship 44-102, Poland
Lodz, Łódź Voivodeship 93-513, Poland
Lisbon, 1649-035, Portugal
Kazan', Tatarstan, Respublika 420029, Russia
Yaroslavl, Yaroslavl Oblast 150054, Russia
Hwasun Gun, Jeonranamdo 58128, South Korea
Suwon, Kyonggi-do 16247, South Korea
Santiago de Compostela, La Coruna 15706, Spain
Zuerich, Canton of Aargau 8091, Switzerland
Bellinzona, Canton Ticino 6500, Switzerland
Dnipro, Dnipropetrovsk Oblast 49102, Ukraine
Dnipropetrovsk, Dnipropetrovsk Oblast 49005, Ukraine
Kropyvnitskiy, Kirovohrad Oblast 25011, Ukraine
Kropyvnytskyi, Kirovohrad Oblast 25006, Ukraine
Kapitanivka Village, Kyivska Oblast 08111, Ukraine
Cottingham-Hull, Kingston Upon Hull HU16 5JQ, United Kingdom
London, London, City of SW3 6JJ, United Kingdom
London, London, City of W6 8RF, United Kingdom