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

Summary

This clinical trial is looking at two new vaccines called ChAdOx1-MAGEA3-NYESO, MVA-MAGEA3 and MVA-NYESO given with patients' standard of care treatment (chemotherapy and an immune checkpoint inhibitor).

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 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.

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 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.

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 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.

BIOLOGICAL

Biological/Vaccine: 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 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 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 a second boost MVA-NYESO vaccine, 21 days following second prime vaccine.

BIOLOGICAL

Biological/Vaccine: 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 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 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 a second boost MVA-NYESO vaccine, 21 days following second prime vaccine.

BIOLOGICAL

Biological/Vaccine: 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 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 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 a second boost MVA-NYESO vaccine, 21 days following second prime vaccine.

BIOLOGICAL

Biological/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = intramuscular (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 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 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.

BIOLOGICAL

Biological/Vaccine: 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 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 21 days later. •For patients who have not progressed: second prime ChAdOx1-MAGAEA3-NYESO vaccine 15 weeks following first prime vaccine and a second MVA-MAGEA3 boost vaccine 21 days after the second prime vaccine.

Sponsors & Collaborators

• Vaccitech Oncology Ltd (VOLT)

  collaborator UNKNOWN

• Cancer Research UK

  lead OTHER

Principal Investigators

• Fiona Blackhall, Prof · The Christie NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-15

Primary Completion

2024-09-18

Completion

2026-10-16

Countries

• United Kingdom

Study Locations