Spots Global Cancer Trial Database for A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC
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Trial Identification
Brief Title: A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC
Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)
Study ID: NCT03669718
Study Description
Brief Summary: This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.
Detailed Description: This study will assess the ability of ISA101b to improve Overall Response Rate in subjects with HPV16 positive OPC, when combined with cemiplimab, an investigational anti-PD-1 antibody being developed by Regeneron Pharmaceuticals. ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16. Trials in HPV16 driven malignancies indicate it has activity in HPV16 driven malignancies including oropharyngeal and cervical cancers. Cemiplimab, also known as REGN2810, is in late stage trials and appears to have similar activity to approved anti PD-1 antibodies in a number of malignancies .
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Moores Cancer Center at the UC San Diego Health, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
ICAHN School of Medicine at Mount Sinai, New York, New York, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
M. D. Anderson Cancer Center, Houston, Texas, United States
University Hospital Antwerp, Antwerp, , Belgium
DFSATR/Oncologia D'Or, Brasília, , Brazil
Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, , Brazil
University Hospital Olomouc, Olomouc, , Czechia
Nemocnice na Bulovce, Prague, , Czechia
Centre Léon Bérard, Lyon, , France
CHU La Timone, Marseille, , France
Antoine Lacassagne Center, Nice, , France
Gustave Roussy, Paris, , France
Hopitaux Universitaires Pitié Salpêtrière Charles Foix, Paris, , France
Universitaetsklinikum Ulm, Ulm, , Germany
Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Nyiregyhaza, , Hungary
University of Pecs Department of Oncotherapy, Pecs, , Hungary
Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
ASST Spedali Civili Brescia, Department of Medical Oncology, Brescia, , Italy
Azienda Ospedaliera San Paolo Polo Universitario, Milan, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
National Cancer Institute - IRCCS "Fondazione G. Pascale", Naples, , Italy
National Cancer Institute Regina Elena, IRCCS, Rome, , Italy
Consultorio de Oncología Médica, Oaxaca, , Mexico
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Radboud University Medical Center, Nijmegen, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Maria Sklodowska-Curie National Institute of Oncology, Gliwice, , Poland
Swietokrzyskie Oncology Center Kielce, Kielce, , Poland
Hospital Clinic of Barcelona, Barcelona, , Spain
Hospital Duran i Reynals - Institut Catala dOncologia ICO, Barcelona, , Spain
Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Marqués de Valdecilla Santander, Santander, , Spain
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
The Royal Marsden NHS Foundation, Chelsea, , United Kingdom
Guy's Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Beacon Centre Musgrove Park Hospital, Taunton, , United Kingdom
Contact Details
Name: Bonnie S. Glisson, MD, BS
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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