A Trial of ChAdOx1 and MVA Vaccines Against MAGE-A3 and NY-ESO-1

PHASE1/PHASE2SuspendedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 15, 2021

Primary Completion Date

September 18, 2024

Study Completion Date

March 6, 2029

Conditions
Non-small Cell Lung Cancer (NSCLC)Squamous Oesophageal Cancer
Interventions
BIOLOGICAL

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)"

BIOLOGICAL

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)"

COMBINATION_PRODUCT

Standard of care treatment

Patients will continue to receive SoC treatment (chemotherapy and checkpoint inhibitor).

BIOLOGICAL

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)"

Trial Locations (9)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Vaccitech Oncology Ltd (VOLT)

UNKNOWN

lead

Cancer Research UK

OTHER