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Brief Title: Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma of the Oral Cavity
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients With High-Risk Squamous Cell Carcinoma of the Oral Cavity
Study ID: NCT02873819
Brief Summary: This is a multi-center, randomized, double-blind clinical trial to assess the safety and efficacy of GL-0817 as a means to prevent disease recurrence in patients considered at high-risk following surgery and adjuvant chemoradiotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
National Institute of Oncology, Budapest, , Hungary
Semmelweis University, Budapest, , Hungary
University of Debrecen Clinical Center, Debrecen, , Hungary
Bacs-Kiskun County Teaching Hospital, Kecskemét, , Hungary
Medical Center of the University of Pecs, Pecs, , Hungary
Oncology Center of Prof. Franciszek Lukaszczyk in Bydgoszcz, Bydgoszcz, , Poland
Swietokrzyskie Oncology Center in Kielce, Kielce, , Poland
Clinical Oncology Center, Omsk, , Russian Federation
Rostov Oncology Research Institute, Rostov-on-Don, , Russian Federation
Leningrad Regional Oncology Center, Saint Petersburg, , Russian Federation
Oncology Center of Moskovskiy District, Saint Petersburg, , Russian Federation
Ogarev Mordovia State University, Saransk, , Russian Federation
Clinical Hospital #1, Sterlitamak, , Russian Federation
Republican Clinical Oncology Center, Ufa, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Institute of Oncology and Radiology of Serbia, Belgrade, , Serbia
Military Medical Academy, Clinic of Maxillofacial Surgery, Belgrade, , Serbia
Oncology Institute of Vojvodina (IOV), Clinic of Medical Oncology, Sremska Kamenica, , Serbia
University Hospital Vall d'Hebron (HUVH), Barcelona, , Spain
University Hospital La Paz, Madrid, , Spain
Parc Tauli Health Corporation, Sabadell, , Spain
Cherkasy Regional Oncology Center, Cherkasy, , Ukraine
Chernihiv Regional Oncology Center, Chernihiv, , Ukraine
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital, Dnipro, , Ukraine
Ivano-Frankivsk Regional Oncology Center, Ivano-Frankivsk, , Ukraine
Communal Non-profit enterprise "Regional Center of Oncology", Kharkiv, , Ukraine
Kyiv Regional Oncology Center, Kyiv, , Ukraine
Lviv Regional Clinical Hospital, Lviv, , Ukraine
Odesa Regional Oncology Center, Odesa, , Ukraine
Poltava Regional Clinical Oncology Center, Poltava, , Ukraine
Sumy Regional Clinical Oncology Center, Sumy, , Ukraine
Podillia Regional Oncology Center, Vinnytsia, , Ukraine