64
Participants
Start Date
August 30, 2017
Primary Completion Date
March 20, 2024
Study Completion Date
March 20, 2024
IMU-131
IMU-131 vaccine is a P467-CRM197 peptide antigen in PBS buffer and Montanide ISA 51 Sterile adjuvant
Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.
Chemotherapy will consist of: cisplatin by intravenous administration at 80 mg/m2 on the first day of each cycle and either 5-FU, 4000 mg/m2 CIV (administered as 1000 mg/m2/day as continuous infusion for 96 hours on days 1 to 4 of each cycle) or capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle), or (in Phase 2 only) oxaliplatin, by intravenous administration at 130 mg/m2 on Day 1 of each cycle and capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle).
ARENSIA Exploratory Medicine IMSP Institutul Oncologic, Chisinau
ARENSIA Exploratory Medicine LLC, Kapitanivka
National Cancer Institute of Thailand, Bangkok
Institute for Oncology and Radiology of Serbia - PPDS, Belgrade
Military Medical Academy, Belgrade
Clinical Hospital Center Bezanijska Kosa, Belgrade
Taipei Veterans General Hospital, Taipei
Oncology Institute of Vojvodina, Kamenitz
Division of Oncology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai
National Cheng-Kung University Hospital, Tainan City
Division of Medical Oncology, Department of Medicine, Prince of Songkla University, Songklanagarind Hospital, Hat Yai
Deenanath Mangeshkar Hospital and Research Centre, Pune
Curie Manavata Cancer Centre, Nashik
HCG NCHRI Cancer Centre, Nagpur
MNJ Institute of Oncology and Regional Cancer Centre, Hyderabad
City Cancer Center, Vijayawada
Victoria Hospital, Bangalore
Shetty's Hospital, Bengaluru
Tata Medical Centre, Kolkata
North East Cancer Hospital and Research Institute, Guwahati
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences, Patna
ARENSIA Exploratory Medicine LLC, Tbilisi
Imugene Limited
INDUSTRY