Spots Global Cancer Trial Database for Study of Cemiplimab in Adults With Cervical Cancer
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Trial Identification
Brief Title: Study of Cemiplimab in Adults With Cervical Cancer
Official Title: An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
Study ID: NCT03257267
Study Description
Brief Summary: The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Arizona Oncology Associates, Phoenix, Arizona, United States
Arizona Oncology Associates, Tucson, Arizona, United States
University of California Irvine, Orange, California, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Cancer Research for the Ozarks, Springfield, Missouri, United States
New York Presbyterian Queens, Flushing, New York, United States
Northwell Health, Lake Success, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
First Health of the Carolinas Outpatient Cancer Center, Pinehurst, North Carolina, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Texas Oncology, P.A., Austin, Texas, United States
St. George Hospital, Kogarah, New South Wales, Australia
Northern NSW Health District, The Tweed Hospital, Tweed Heads, New South Wales, Australia
Royal Brisbane & Women's Hospital, Herston, Queensland, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
St. John of God Subiaco Hospital, Subiaco, Western Australia, Australia
OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie, Aalst, , Belgium
Institut Bordet, Brussels, , Belgium
Cliniques universitaires Saint-Luc, Bruxelles, , Belgium
UZLeuven Gynaelologic Oncology, Leuven, , Belgium
CHC Saint Joseph, Liège, , Belgium
CHU Liège, Liège, , Belgium
CHU UCL Namur site Sainte Elisabeth, Namur, , Belgium
Liga Norte Riograndense Contra o Câncer, Natal, Rio Grande Do Norte, Brazil
Hosptial Sao Lucas da PUC de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Novos Tratamentos Itajai, Itajai, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, São Paulo, Brazil
Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM, Caxias do Sul, , Brazil
Instituto Nacional de Cancer - INCA, Rio de Janeiro, , Brazil
Instituto COI de Pesquisa, Rio de Janeiro, , Brazil
Tom Baker Cancer Center, Calgary, Alberta, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
London Health Sciences Centre, London, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hospital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal, Montréal, Quebec, Canada
Jewish General Hospital, Montréal, Quebec, Canada
General Hospital of Athens Alexandra, Athens, , Greece
University Hospital of Ioannina, Ioannina, , Greece
General Hospital of Patras, Patras, , Greece
Euromedica General Clinic, B'Oncology Clinic, Thessaloniki, , Greece
Azienda Ospedaliero Universitaria di Bologna, Bologna, , Italy
U.O Oncologia Medica P.O Vito Fazzi, Lecce, , Italy
Asst Lecco, Lecco, , Italy
Irst Irccs, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
AUSL, IRCCS di Reggio Emilia, Reggio Emilia, , Italy
Fondazione Policlinico Agostino Gemelli IRCCS di Roma, Roma, , Italy
Regina Elena National Cancer Institute, Rome, , Italy
Shikoku Cancer Center, Matsuyama, Ehime, Japan
Ehime University Hospital, Toon, Ehime, Japan
Fukui University Hospital, Yoshida-gun, Fukui, Japan
Kurume University Hospital, Kurume, Fukuoka, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
St. Marianna University School of Medicine Hospital, Kawasaki, Kanagawa, Japan
University of the Ryukyus Hospital, Nakagami-gun, Okinawa, Japan
Saitama Medical University, Saitama, Saitama Prefecture, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan
Kyorin University Hospital, Mitaka, Tokyo, Japan
Saitama Cancer Center, Saitama, Tokyo, Japan
National Kyushu Cancer Center, Fukuoka, , Japan
Kagoshima City Hospital, Kagoshima, , Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Bialostockie Centrum Onkologii, Białystok, , Poland
Szpitale Pomorskie, Gdynia, , Poland
Center and Institute of Oncology Gliwice, Gliwice, , Poland
Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli, Lublin, , Poland
Greater Poland Cancer Center, Poznań, , Poland
Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary, Ivanovo, Ivanovo Region, Russian Federation
State Budgetary Healthcare Institution "Oncology Dispensary" of Ministry of Healthcare of the Kabardino-Balkarian Republic, Nal'chik, Kabardino-Balkarian, Russian Federation
A. Tsyb Medical Radiological Research Center, Obninsk, Kaluga, Russian Federation
State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region, Krasnodar, Krasnodar Territory, Russian Federation
State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI "LROD"), Vsevolozhsk, Leningrad Region, Russian Federation
State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic, Kazan, Tatarstan, Russian Federation
Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary, Omsk, , Russian Federation
State Budgetary Institution of Healthcare "Orenburg Regional Clinical Oncology Dispensary", Orenburg, , Russian Federation
Saint- Petersburg State Budgetary institution of Healthcare "City Clinical Oncological Dispensary", Saint Petersburg, , Russian Federation
Hospital Universitario Son Espases, Palma de Mallorca, Illes Balears, Spain
Vall d´Hebron University Hospital, Barcelona, , Spain
Hospital Reina Sofia, Cordoba, , Spain
Instituto Catalan de Oncologia de Gerona, Girona, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario HM Sanchinarro CIOCC, Madrid, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Taichung Veterans General Hospital, Taichung, , Taiwan
MacKay Memorial Hospital, Taipei City, , Taiwan
Koo-Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Velindre Cancer Centre, Cardiff, , United Kingdom
NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care, Glasgow, , United Kingdom
University College Hospital, London, , United Kingdom
Royal Marsden NHS Foundation Trust, Chelsea, London, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Royal Marsden NHS Foundation Trust, Sutton, Sutton, , United Kingdom
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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