15
Participants
Start Date
October 15, 2021
Primary Completion Date
September 18, 2024
Study Completion Date
March 6, 2029
ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp)
"Patients commence their SoC chemotherapy in combination with an immune checkpoint inhibitor in 3 weekly cycles. Patients are screened during the first 2 cycles of SoC treatment to confirm eligibility for the trial.~Patients who receive trial vaccines (safety run in stage, Arm A of the NSCLC randomisation cohort and Squamous Oesophageal Cancer Cohort) continue to receive their SoC treatment plus:~* First prime ChAdOx1-MAGEA3-NYESO vaccine on Cycle 3 Day 1 of SoC treatment.~* First boost MVA-MAGEA3 vaccine, and if applicable a first boost MVA-NYESO vaccine, 21 days later.~* For patients who have not progressed: second prime ChAdOx1-MAGAEA3-NYESO vaccine 15 weeks following first prime vaccine~* Second boost MVA-MAGAE3 vaccine, and if applicable a second boost MVA-NYESO vaccine, 21 days following second prime vaccine~Patients in Arm B of the NSCLC randomisation cohort will continue to receive their SoC treatment only throughout the trial (i.e. no trial vaccines)"
MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu)
"Patients commence their SoC chemotherapy in combination with an immune checkpoint inhibitor in 3 weekly cycles. Patients are screened during the first 2 cycles of SoC treatment to confirm eligibility for the trial.~Patients who receive trial vaccines (safety run in stage, Arm A of the NSCLC randomisation cohort and Squamous Oesophageal Cancer Cohort) continue to receive their SoC treatment plus:~* First prime ChAdOx1-MAGEA3-NYESO vaccine on Cycle 3 Day 1 of SoC treatment.~* First boost MVA-MAGEA3 vaccine, and if applicable a first boost MVA-NYESO vaccine, 21 days later.~* For patients who have not progressed: second prime ChAdOx1-MAGAEA3-NYESO vaccine 15 weeks following first prime vaccine~* Second boost MVA-MAGAE3 vaccine, and if applicable a second boost MVA-NYESO vaccine, 21 days following second prime vaccine~Patients in Arm B of the NSCLC randomisation cohort will continue to receive their SoC treatment only throughout the trial (i.e. no trial vaccines)"
Standard of care treatment
Patients will continue to receive SoC treatment (chemotherapy and checkpoint inhibitor).
MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu)
"Patients commence their SoC chemotherapy in combination with an immune checkpoint inhibitor in 3 weekly cycles. Patients are screened during the first 2 cycles of SoC treatment to confirm eligibility for the trial.~Patients who receive trial vaccines (safety run in stage, Arm A of the NSCLC randomisation cohort and Squamous Oesophageal Cancer Cohort) continue to receive their SoC treatment plus:~* First prime ChAdOx1-MAGEA3-NYESO vaccine on Cycle 3 Day 1 of SoC treatment.~* First boost MVA-MAGEA3 vaccine, and if applicable a first boost MVA-NYESO vaccine, 21 days later.~* For patients who have not progressed: second prime ChAdOx1-MAGAEA3-NYESO vaccine 15 weeks following first prime vaccine~* Second boost MVA-MAGAE3 vaccine, and if applicable a second boost MVA-NYESO vaccine, 21 days following second prime vaccine~Patients in Arm B of the NSCLC randomisation cohort will continue to receive their SoC treatment only throughout the trial (i.e. no trial vaccines)"
Blackpool Victoria Hospital, Blackpool
Beatson West of Scotland Cancer Centre, Glasgow
St James's University Hospital, Leeds
Leicester Royal Infirmary, Leicester
Guy's and St Thomas' NHS Foundation Trust, London
The Christie NHS Foundation Trust, Manchester
Churchill Hospital, Oxford
Royal Preston Hospital, Preston
Southampton General Hospital, Southampton
Lead Sponsor
Vaccitech Oncology Ltd (VOLT)
UNKNOWN
Cancer Research UK
OTHER