Non-small Cell Lung Cancer (NSCLC)Phase 1/2NCT04908111
A Trial of ChAdOx1 and MVA Vaccines Against MAGE-A3 and NY-ESO-1
A Phase 1/2 study testing ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp), MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu) and MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu) in people with Non-small Cell Lung Cancer (NSCLC) and Squamous Oesophageal Cancer, run by Cancer Research UK at 9 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Squamous Oesophageal Cancer
- What is being tested?
- ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp), MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu) and MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 15 Oct 2021to 16 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written (signed and dated) informed consent for both pre-screening and the main trial and capable of co-operating with any investigational medicinal product (IMP) administration and follow-up.
- Histologically or cytologically proven Stage IIIB, IIIC or IV squamous NSCLC or Stage IIIB or IV non-squamous NSCLC scheduled to receive pembrolizumab and chemotherapy as SoC at the time of enrolment or randomisation. Patients can receive up to two cycles of SoC pembrolizumab in combination with chemotherapy prior to enrolment or randomisation to the trial.
- Or histologically proven inoperable Stage III or IV squamous cell carcinomas of the oesophagus or gastro-oesophageal junction (referred to as squamous oesophageal cancer) scheduled to receive or continue to receive chemotherapy and pembrolizumab as SoC at the time of enrolment.
- NSCLC patients with no prior immune checkpoint inhibitor therapy prior to the pembrolizumab they are receiving in combination with chemotherapy at time of enrolment or randomisation.
- For non-squamous NSCLC patients, the patient has not received previous systemic therapy for advanced/metastatic disease. Completion of treatment for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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.
- For squamous NSCLC patients, the patient has not received previous cytotoxic chemotherapy for advanced/metastatic disease. Completion of treatment for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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.
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- Or patients with squamous oesophageal cancer with no prior systemic therapy for advanced disease and with no prior immune checkpoint inhibitor therapy prior to the chemotherapy and immune checkpoint inhibitor they are receiving at time of enrolment to the trial. Completion of treatment for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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.
- Have at least one measurable lesion according to RECIST v1.1. Note: A measurable lesion may be biopsied at screening and on trial, however that lesion cannot be selected as a target lesion for disease assessment according to RECIST v1.1.
- Confirmed PD-L1 status (tumour proportion score) for NSCLC patients. Or a confirmed PD-L1 combined positive score for patients with squamous oesophageal cancer.
- Archival tumour tissue or new biopsy expressing MAGE-A3 as demonstrated by quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR).
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.
- Haemoglobin ≥90 g/L
- Absolute neutrophil count ≥1.5×10^9/L (growth factor support Granulocyte-Colony Stimulating Factor is allowed when used as part of routine supportive therapy for SoC)
- Platelet count ≥100×10^9/L
- International normalized ratio (INR) ≤1.5 AND prothrombin time (PT) OR Activated partial thromboplastin time (aPTT) ≤1.5 × Upper Limit of Normal (ULN) unless participant is receiving anticoagulant therapy as long as INR or PT/aPTT is within therapeutic range of intended use of anticoagulants.
- Bilirubin ≤1.5 × ULN OR <3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia)
- Alanine aminotransferase or aspartate aminotransferase ≤3.0 × ULN OR ≤5.0 × ULN in presence of liver metastases
- Calculated creatinine clearance (using the Cockcroft \& Gault [C\&G] formula) ≥50 mL/min or serum creatinine ≤1.5 × ULN
- Aged 18 years or over at the time pre-screening consent is given.
Who cannot join
- 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 for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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. Palliative radiotherapy is allowed. Irradiated lesions will not be evaluable for response.
- 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/radical/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. Palliative radiotherapy is allowed. Irradiated lesions will not be evaluable for response.
- Or for patients with squamous oesophageal cancer - patients who have previously received systemic therapy for advanced disease and with no prior immune checkpoint inhibitor therapy prior to the SoC treatment outlined in this clinical trial. Completion of treatment for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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. Palliative radiotherapy is allowed. Irradiated lesions will not be evaluable for response.
- 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.
- 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.
- 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.
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- Women of child-bearing potential (or are already pregnant or lactating). However, those patients who meet the following points are considered eligible:
- Have a negative serum or urine pregnancy test before enrolment or randomisation and;
- Agree to use two forms of contraception (one effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence, effective from the first administration of ChAdOx1-MAGEA3-NYESO, throughout the treatment phase of the trial and for 6 months afterwards.
- Male patients with partners of child-bearing potential. However, those patients who meet the following points are considered eligible:
- They agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence effective from the Cycle 3 Day 1 of SoC treatment, throughout the treatment phase of the trial and for six months afterwards.
- Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intra-uterine device, diaphragm with spermicidal gel or sexual abstinence.
- Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
- 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 and Sponsor agree would not compromise patient safety on trial are eligible.
- Electrocardiogram (ECG) with clinically significant abnormalities or with QTcF interval (QT corrected using Fridericia's formula) >480 msec.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- 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.
- 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.
- Has received COVID-19 Vaccine AstraZeneca (previously named AZD1222 or ChAdOx1-nCoV-19) vaccine within six weeks of commencing chemotherapy and an immune checkpoint inhibitor.
- Has received any other live vaccination within four weeks before enrolment or randomisation to the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- 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. Use of short (<7 day) courses of steroids as part of the SoC treatment management is allowed.
- 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.
- Has previously experienced severe hypersensitivity (greater than or equal to Grade 3) to an immune checkpoint inhibitor, ChAdOx1 or MVA vaccines and/or any of their excipients.
- History of a severe allergy to eggs or history of severe allergic reaction to any previous vaccination.
- History of heparin-induced thrombocytopenia and thrombosis.
- History of Capillary Leak Syndrome.
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I/IIa trial. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable.
- Any other condition, which in the Investigator's opinion, would not make the patient a good candidate for the clinical trial.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
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
About this study
Official title: A Cancer Research UK Phase I/IIa Trial of Chimpanzee Adenovirus Oxford 1 (ChAdOx1) and Modified Vaccinia Ankara (MVA) Vaccines Against MAGE-A3 and NY-ESO-1 With Standard of Care Treatment (Chemotherapy and an Immune Checkpoint Inhibitor)
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).
Read the detailed description
Patients with non-small cell lung cancer (NSCLC) or squamous oesophageal cancer will be entered into the trial as these tumour types are 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. It is expected the immune system will 'learn' that these proteins are foreign to the body. The immune system should then attack the proteins on the cancer cells, killing them. It is expected 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 consisting of two cohorts:
- NSCLC Randomisation Cohort of approximately 80 patients with NSCLC 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.
- Squamous Oesophageal Cancer Cohort: Approximately 17 patients with squamous oesophageal cancer will be recruited to receive trial vaccines with their standard of care treatment.
The main aims of the trial are to find out:
- More about potential side effect of the vaccine and how they can be managed.
- Whether the vaccines with standard of care treatment are better at shrinking NSCLC than just the standard of care treatment alone.
- What happens to the vaccines inside the body.
- Being tested
- ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp), MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu), Standard of care treatment, MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu), Biological/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp)
- Keywords
- Immunotherapy, Vaccine, Cancer, Oncology, Lung Cancer, NSCLC Non-small cell lung cancer, Esophageal neoplasms, Neoplasms, Squamous Cell
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp)Biological
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.
MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu)Biological
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.
Standard of care treatmentCombination product
Patients will continue to receive SoC treatment (chemotherapy and checkpoint inhibitor).
MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu)Biological
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/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp)Biological
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/Vaccine: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu)Biological
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/Vaccine: MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu)Biological
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/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = intramuscular (IM) injection, Dose = 5×10^10 vp)Biological
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/Vaccine: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Safety Run-In (Cohort 1) | Experimental | Three evaluable patients will receive the trial vaccines with Standard of Care (SoC) treatment to confirm they are safe before opening the next stage of the trial. These patients will not be randomised. Receives: Biological: Biological/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = intramuscular (IM) injection, Dose = 5×10^10 vp); Biological: Biological/Vaccine: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu) |
| Safety Run-In (Cohort 2) | Experimental | Three evaluable patients will receive the trial vaccines with SoC treatment to confirm they are safe before opening the next stage of the trial. These patients will not be randomised. Receives: Biological: Biological/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp); Biological: Biological/Vaccine: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu); Biological: Biological/Vaccine: MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu) |
| NSCLC Arm A: Trial vaccines with SoC treatment | Experimental | Approximately 40 patients will be randomised to receive the trial vaccines with SoC treatment in this arm. Receives: Biological: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp); Biological: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu); Biological: MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu) |
| NSCLC Arm B: SoC treatment | Other | Approximately 40 patients will be randomised to receive SoC treatment alone in this arm. Receives: Combination Product: Standard of care treatment |
| Squamous Oesophageal Cancer Cohort | Experimental | Approximately 17 patients with squamous oesophageal cancer will received the trial vaccines with SoC treatment. Receives: Biological: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp); Biological: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu); Biological: MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of the trial vaccines with SoC treatment (chemotherapy and an immune checkpoint inhibitor).
Incidence of adverse events (including injection site reactions and toxicity), including relatedness, seriousness and severity (graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 5.0).
Measured: From time of written consent to participate in the trial until the End of Treatment visit for each patient. Any trial vaccine-related serious adverse events that become known after this period will be reported up to the end of trial (Max 5 years).
Secondary outcomes (4)
To determine the efficacy (Progression Free Survival [PFS], in months) of the trial vaccines when given with SoC treatment (chemotherapy and immune checkpoint inhibitor).
PFS will be assessed as time from Cycle 3 Day 1 of SoC treatment to the date of disease progression using Response Evaluation Criteria in Solid Tumours (RECIST) and immune RECIST (iRECIST).
Measured: Until end of efficacy and survival follow-up (Max 5 years).
To determine the efficacy (Overall Response Rate [ORR], in months) of the trial vaccines when given with SoC treatment (chemotherapy and immune checkpoint inhibitor).
ORR will be reported as the number of randomised patients who have achieved a complete response or partial response.
Measured: Until end of efficacy and survival follow-up (Max 5 years).
To determine the efficacy (Overall Survival [OS], in months) of the trial vaccines when given with SoC treatment (chemotherapy and immune checkpoint inhibitor).
OS will be assessed as time from Cycle 3 Day 1 of SoC treatment to the date of death from any cause.
Measured: Until end of efficacy and survival follow-up (Max 5 years).
To determine the immunogenicity (antigen-specific peripheral response) of the trial vaccines given with SoC treatment (chemotherapy and an immune checkpoint inhibitor).
Percentage of patients showing peripheral immune response. Immunological response will be measured in patient blood by antigen-specific T cells by ex vivo ELISpot assay.
Measured: Screening (prior to commencing SoC treatment, Cycle 3 Day 1 (each cycle is 21 days), Cycle 3 Day 15/2 weeks after ChAdOx1-MAGEA3-NYESO vaccination, Cycle 4 Day 1, Cycle 4 Day 7/1 week after MVA vaccination and at End of Treatment visit (Max 40 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start15 Oct 2021
- Primary completion18 Sep 2024
- Study completion16 Oct 2026 (estimated)
Why it stopped: Sponsor has decided to permanently close recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Collaborators
- Vaccitech Oncology Ltd (VOLT)
- Responsible party
- Sponsor
- Investigators
- Fiona Blackhall, Prof, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908111
- Sponsor's protocol ID
- CRUKD/20/001
- Other IDs
- 2019-003015-64, 2019
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data that underlie the results reported on a publicly accessible database (text, figures, tables and supplementary information) will be shared with Cancer Research UK funded/ employed researchers whose proposed use of the data is approved by a review committee of the sponsor. All requests made within 5 years from the end of trial will be considered; requests made subsequently will be considered where possible. Data sharing requests should be sent to: drugdev@cancer.org.uk.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cancer Research UK Phase I/IIa Trial of Chimpanzee Adenovirus Oxford 1 (ChAdOx1) and Modified Vaccinia Ankara (MVA) Vaccines Against MAGE-A3 and NY-ESO-1 With Standard of Care Treatment (Chemotherapy and an Immune Checkpoint Inhibitor)
- ClinicalTrials.gov ID
- NCT04908111
- Acronym / sponsor ID
- CRUKD/20/001
- Keywords
- Immunotherapy, Vaccine, Cancer, Oncology, Lung Cancer, NSCLC Non-small cell lung cancer, Esophageal neoplasms, Neoplasms, Squamous Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor has decided to permanently close recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Collaborators
- Vaccitech Oncology Ltd (VOLT)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients with non-small cell lung cancer (NSCLC) or squamous oesophageal cancer will be entered into the trial as these tumour types are 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. It is expected the immune system will 'learn' that these proteins are foreign to the body. The immune system should then attack the proteins on the cancer cells, killing them. It is expected 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 consisting of two cohorts:
- NSCLC Randomisation Cohort of approximately 80 patients with NSCLC 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.
- Squamous Oesophageal Cancer Cohort: Approximately 17 patients with squamous oesophageal cancer will be recruited to receive trial vaccines with their standard of care treatment.
The main aims of the trial are to find out:
- More about potential side effect of the vaccine and how they can be managed.
- Whether the vaccines with standard of care treatment are better at shrinking NSCLC than just the standard of care treatment alone.
- What happens to the vaccines inside the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Safety Run-In (Cohort 1) | Experimental | Biological: Biological/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = intramuscular (IM) injection, Dose = 5×10^10 vp), Biological: Biological/Vaccine: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu)Three evaluable patients will receive the trial vaccines with Standard of Care (SoC) treatment to confirm they are safe before opening the next stage of the trial. These patients will not be randomised. |
| Safety Run-In (Cohort 2) | Experimental | Biological: Biological/Vaccine: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp), Biological: Biological/Vaccine: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu), Biological: Biological/Vaccine: MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu)Three evaluable patients will receive the trial vaccines with SoC treatment to confirm they are safe before opening the next stage of the trial. These patients will not be randomised. |
| NSCLC Arm A: Trial vaccines with SoC treatment | Experimental | Biological: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp), Biological: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu), Biological: MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu)Approximately 40 patients will be randomised to receive the trial vaccines with SoC treatment in this arm. |
| NSCLC Arm B: SoC treatment | Other | Combination Product: Standard of care treatmentApproximately 40 patients will be randomised to receive SoC treatment alone in this arm. |
| Squamous Oesophageal Cancer Cohort | Experimental | Biological: ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp), Biological: MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu), Biological: MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu)Approximately 17 patients with squamous oesophageal cancer will received the trial vaccines with SoC treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Written (signed and dated) informed consent for both pre-screening and the main trial and capable of co-operating with any investigational medicinal product (IMP) administration and follow-up.
- Histologically or cytologically proven Stage IIIB, IIIC or IV squamous NSCLC or Stage IIIB or IV non-squamous NSCLC scheduled to receive pembrolizumab and chemotherapy as SoC at the time of enrolment or randomisation. Patients can receive up to two cycles of SoC pembrolizumab in combination with chemotherapy prior to enrolment or randomisation to the trial.
- Or histologically proven inoperable Stage III or IV squamous cell carcinomas of the oesophagus or gastro-oesophageal junction (referred to as squamous oesophageal cancer) scheduled to receive or continue to receive chemotherapy and pembrolizumab as SoC at the time of enrolment.
- NSCLC patients with no prior immune checkpoint inhibitor therapy prior to the pembrolizumab they are receiving in combination with chemotherapy at time of enrolment or randomisation.
- Or patients with squamous oesophageal cancer with no prior systemic therapy for advanced disease and with no prior immune checkpoint inhibitor therapy prior to the chemotherapy and immune checkpoint inhibitor they are receiving at time of enrolment to the trial. Completion of treatment for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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.
Key exclusion criteria (28 listed)
- 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 for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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. Palliative radiotherapy is allowed. Irradiated lesions will not be evaluable for response.
- 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/radical/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. Palliative radiotherapy is allowed. Irradiated lesions will not be evaluable for response.
- Or for patients with squamous oesophageal cancer - patients who have previously received systemic therapy for advanced disease and with no prior immune checkpoint inhibitor therapy prior to the SoC treatment outlined in this clinical trial. Completion of treatment for earlier stage disease with chemotherapy with or without radiotherapy as part of neoadjuvant/radical/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. Palliative radiotherapy is allowed. Irradiated lesions will not be evaluable for response.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | NSCLC Arm A: Trial vaccines with SoC treatment, Squamous Oesophageal Cancer Cohort |
| 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. | Biological | NSCLC Arm A: Trial vaccines with SoC treatment, Squamous Oesophageal Cancer Cohort |
| Standard of care treatmentPatients will continue to receive SoC treatment (chemotherapy and checkpoint inhibitor). | Combination product | NSCLC Arm B: SoC treatment |
| 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 | NSCLC Arm A: Trial vaccines with SoC treatment, Squamous Oesophageal Cancer Cohort |
| 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 | Safety Run-In (Cohort 2) |
| 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 | Safety Run-In (Cohort 2) |
| 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 | Safety Run-In (Cohort 2) |
| 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 | Safety Run-In (Cohort 1) |
| 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. | Biological | Safety Run-In (Cohort 1) |
Primary outcome
To assess the safety and tolerability of the trial vaccines with SoC treatment (chemotherapy and an immune checkpoint inhibitor).
Time frame: From time of written consent to participate in the trial until the End of Treatment visit for each patient. Any trial vaccine-related serious adverse events that become known after this period will be reported up to the end of trial (Max 5 years).
Incidence of adverse events (including injection site reactions and toxicity), including relatedness, seriousness and severity (graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 5.0).
4 secondary outcomes
To determine the efficacy (Progression Free Survival [PFS], in months) of the trial vaccines when given with SoC treatment (chemotherapy and immune checkpoint inhibitor).
Time frame: Until end of efficacy and survival follow-up (Max 5 years).
To determine the efficacy (Overall Response Rate [ORR], in months) of the trial vaccines when given with SoC treatment (chemotherapy and immune checkpoint inhibitor).
Time frame: Until end of efficacy and survival follow-up (Max 5 years).
To determine the efficacy (Overall Survival [OS], in months) of the trial vaccines when given with SoC treatment (chemotherapy and immune checkpoint inhibitor).
Time frame: Until end of efficacy and survival follow-up (Max 5 years).
To determine the immunogenicity (antigen-specific peripheral response) of the trial vaccines given with SoC treatment (chemotherapy and an immune checkpoint inhibitor).
Time frame: Screening (prior to commencing SoC treatment, Cycle 3 Day 1 (each cycle is 21 days), Cycle 3 Day 15/2 weeks after ChAdOx1-MAGEA3-NYESO vaccination, Cycle 4 Day 1, Cycle 4 Day 7/1 week after MVA vaccination and at End of Treatment visit (Max 40 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- MAGE Abstract, ESMO Immuno-Oncology Congress 2025 MAGELink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data that underlie the results reported on a publicly accessible database (text, figures, tables and supplementary information) will be shared with Cancer Research UK funded/ employed researchers whose proposed use of the data is approved by a review committee of the sponsor. All requests made within 5 years from the end of trial will be considered; requests made subsequently will be considered where possible. Data sharing requests should be sent to: drugdev@cancer.org.uk.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Blackhall, Prof principal investigator
The Christie NHS Foundation Trust
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ChAdOx1-MAGEA3-NYESO (Route = IM injection, Dose = 5×10^10 vp), MVA-MAGEA3 (Route = IM injection, Dose = 1.3×10^8 pfu) and MVA-NYESO (Route = IM injection, Dose = 1.5×10^8 pfu) in people with Non-small Cell Lung Cancer (NSCLC) and Squamous Oesophageal Cancer, run by Cancer Research UK at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of the trial vaccines with SoC treatment (chemotherapy and an immune checkpoint inhibitor). (time frame: From time of written consent to participate in the trial until the End of Treatment visit for each patient. Any trial vaccine-related serious adverse events that become known after this period will be reported up to the end of trial (Max 5 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.