80
Participants
Start Date
March 30, 2017
Primary Completion Date
May 17, 2021
Study Completion Date
May 25, 2021
GL-0817
GL-0817, IV at the dose 1.5 mg will be administered 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
Hiltonol
Hiltonol will be administered intramuscularly at the dose of 1.4 mg as adjuvant to GL0817, 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
Sargramostim
Sargramostim will be administered intramuscularly at the dose of 100 μg/m2, as adjuvant to GL0817, 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
cyclophosphamide
cyclophosphamide will be administered IV at a dose of 200 mg/m2 (maximum dose 400 mg) one day prior to first three vaccinations of GL0817 with adjuvants
Placebo
Placebo (normal saline) will be administered as per the schedule of cyclophosphamide and GL0817/adjuvants administration
University of Maryland Greenebaum Cancer Center, Baltimore
National Institute of Oncology, Budapest
Semmelweis University, Budapest
University of Debrecen Clinical Center, Debrecen
Bacs-Kiskun County Teaching Hospital, Kecskemét
Medical Center of the University of Pecs, Pécs
Oncology Center of Prof. Franciszek Lukaszczyk in Bydgoszcz, Bydgoszcz
Swietokrzyskie Oncology Center in Kielce, Kielce
Clinical Oncology Center, Omsk
Rostov Oncology Research Institute, Rostov-on-Don
Leningrad Regional Oncology Center, Saint Petersburg
Oncology Center of Moskovskiy District, Saint Petersburg
Ogarev Mordovia State University, Saransk
Clinical Hospital #1, Sterlitamak
Republican Clinical Oncology Center, Ufa
Regional Clinical Oncology Hospital, Yaroslavl
Institute of Oncology and Radiology of Serbia, Belgrade
Military Medical Academy, Clinic of Maxillofacial Surgery, Belgrade
Oncology Institute of Vojvodina (IOV), Clinic of Medical Oncology, Kamenitz
University Hospital Vall d'Hebron (HUVH), Barcelona
University Hospital La Paz, Madrid
Parc Tauli Health Corporation, Sabadell
Cherkasy Regional Oncology Center, Cherkasy
Chernihiv Regional Oncology Center, Chernihiv
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital, Dnipro
Ivano-Frankivsk Regional Oncology Center, Ivano-Frankivsk
"Communal Non-profit enterprise Regional Center of Oncology", Kharkiv
Kyiv Regional Oncology Center, Kyiv
Lviv Regional Clinical Hospital, Lviv
Odesa Regional Oncology Center, Odesa
Poltava Regional Clinical Oncology Center, Poltava
Sumy Regional Clinical Oncology Center, Sumy
Podillia Regional Oncology Center, Vinnytsia
Lead Sponsor
Gliknik Inc.
INDUSTRY