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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
David
Gear
david.gear@cancer.org.uk
Georgia
Gillan
Georgia.Gillan@cancer.org.uk
David
Gear
david.gear@cancer.org.uk
Dr
Fiona
Blackhall
fiona.blackhall@christie.nhs.uk
Ms
Olivia
Frank
olivia.frank@cancer.org.uk
Malignant neoplasms of respiratory and intrathoracic organs
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This clinical trial is looking at two new vaccines called ChAdOx1-MAGEA3-NYESO and MVA-MAGEA3 given with patients’ standard of care treatment (chemotherapy and an immune checkpoint inhibitor).
Patients with non-small cell lung cancer (NSCLC) will be entered into the trial as this tumour type is commonly known to have MAGE-A3 and NY-ESO-1 proteins on their cancer cells. The vaccines contain harmless parts of these proteins allowing them to show these proteins to the immune system. We expect the immune system to ‘learn’ that these proteins are foreign to the body. The immune system should then attack the proteins on the cancer cells, killing them. We expect the vaccines will help the chemotherapy and immune checkpoint inhibitor to work better.
This is a first-in-human clinical trial which has two stages:
A ‘safety run in’ stage where six evaluable patients will receive the trial vaccines with standard of care treatment to confirm they are safe before opening the next stage.
A ‘rolling recruitment’ stage where approximately 80 patients will be randomly allocated by computer (randomised) to one of two groups (arms). Patients in Arm A will receive the vaccines with their standard of care treatment and patients in Arm B will continue with their standard of care treatment alone. There is a 1 in 2 chance patients will receive the vaccines.
The main aims of this trial are to find out:
- More about potential side effects of the vaccines and how they can be managed
- Whether the vaccines with standard treatment are better at shrinking cancer than just the standard of care treatment patients receive
- What happens to the vaccines inside the body
This trial will be conducted at approximately 10 sites across the UK.
This trial is sponsored by Cancer Research UK (CRUK). The vaccines are developed by Vaccitech Ltd.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Vaccine;
You can take part if:
You may not be able to take part if:
1. For non-squamous NSCLC patients, patients who have received previous systemic therapy for advanced/metastatic disease prior to the pembrolizumab they are receiving in combination with chemotherapy at time of enrolment or randomisation. Completion of treatment with chemotherapy and/or radiotherapy as part of neoadjuvant therapy is allowed as long as the therapy was completed at least 6 months prior to the diagnosis of recurrent locally advanced or metastatic disease. For squamous NSCLC patients, patients who have received previous cytotoxic chemotherapy for advanced/metastatic disease prior to the pembrolizumab they are receiving in combination with chemotherapy at time of enrolment or randomisation. Completion of treatment for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/concurrent/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of recurrent locally advanced or metastatic disease. Or (when included in the trial) For patients with GO cancer - patients who have previously received treatment for their current GO cancer apart from the SoC treatment outlined in this clinical trial. 2. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., anti-CTLA-4, OX 40, anti-CD137). This does not include the immune checkpoint inhibitor patients receive in combination with chemotherapy commencing during screening prior to enrolment or randomisation to the trial. 3. Current or prior malignancy which could affect safety or efficacy assessment of the IMP or compliance with the protocol or interpretation of results. Patients with curatively-treated non-melanoma skin cancer, non-muscle-invasive bladder cancer, or carcinomas-in-situ are eligible. 4. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with symptomatically active brain metastases or leptomeningeal metastases. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during trial screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 5. Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who meet the points described in the protocol are considered eligible. 6. Male patients with partners of child-bearing potential. However, those patients who meet the points described in the protocol are considered eligible. 7. Major thoracic or abdominal surgery from which the patient has not yet recovered. Patients who have undergone other types of surgery which the Chief Investigator (CI) and Sponsor agree would not compromise patient safety on trial are eligible. 8. Electrocardiogram (ECG) with clinically significant abnormalities or with QTcF interval (QT corrected using Fridericia’s formula) > 480 msec. 9. At high medical risk because of non-malignant systemic disease including active uncontrolled infection. 10. Historically known to be serologically positive for hepatitis B or human immunodeficiency virus (HIV). Patients with previous Hepatitis C exposure but no current infection are eligible to participate. 11. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. 12. Has received AZD1222 (previously named ChAdOx1-nCoV-19) vaccine within six weeks of commencing chemotherapy and an immune checkpoint inhibitor. 13. Has received any other live vaccination within four weeks before enrolment or randomisation to the trial. 14. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. 15. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease (GVHD). 16. Has previously experienced severe hypersensitivity (> = Grade 3) to an immune checkpoint inhibitor, ChAdOx1 or MVA vaccines and/or any of their excipients. 17. History of a severe allergy to eggs or history of severe allergic reaction to any previous vaccination.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Georgia
Gillan
Georgia.Gillan@cancer.org.uk
David
Gear
david.gear@cancer.org.uk
David
Gear
david.gear@cancer.org.uk
Ms
Olivia
Frank
olivia.frank@cancer.org.uk
Dr
Fiona
Blackhall
fiona.blackhall@christie.nhs.uk
The study is sponsored by CANCER RESEARCH UK and funded by CANCER RESEARCH UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 48242
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