24
Participants
Start Date
November 30, 2020
Primary Completion Date
November 30, 2024
Study Completion Date
May 31, 2025
IMU-201 (administered as PD1-Vaxx) - Regimen 1
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study.
IMU-201 (administered as PD1-Vaxx) - Regimen 2
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study.
IMU-201 (administered as PD1-Vaxx) - Regimen 3
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study.
Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Standard of care chemotherapy
Chemotherapy to be administered according to the prescribing information.
Chris O'Brien Lifehouse, Camperdown
Macquarie University, Macquarie
Cabrini Malvern Hospital, Melbourne
Ohio State University Medical Center, Columbus
Mayo Clinic, Phoenix
Hackensack University Medical Center, Hackensack
Imugene Limited
INDUSTRY