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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.
Prof
David
Church
None
OCTO INTERCEPT-Lynch
Trial Team
octo-intercept-lynch@oncology.ox.ac.uk
Lynch syndrome (LS)
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 is a study testing a treatment called mRNA-4194 for people with Lynch syndrome (LS). People with LS have a change in one of their genes, meaning their bodies find it harder to stop cells becoming abnormal. This increases the risk of many types of cancer, most commonly in the bowel and, in women, the womb. Bowel cancer in LS is often preceded by a small growth of abnormal cells called a polyp, which can be identified/removed by colonoscopy.
The mRNA-4194 treatment aims to help the immune system recognise and remove these early abnormal cells before they cause cancer. It works by giving the body short-term instructions to make harmless pieces of protein found in these abnormal cells. This may help the immune system train itself to spot and destroy similar cells in future.
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:
You can take part if:
You may not be able to take part if:
1. Active cancer or pre-malignant condition, other than superficial non-melanoma skin cancers (e.g., basal cell carcinoma and squamous cell carcinoma), at time of enrolment. 2. Received treatment, including surgical resection, for cancer within the preceding 3 years for LS-related cancers or within the preceding 5 years for non-LS-related cancer. 3. Toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline with the exceptions of alopecia, vitiligo, and, if approved by the Chief Investigator or designated clinician , other toxicities not reasonably expected to recover.4. For Part 2 only: A diagnosis of active inflammatory bowel disease which would compromise identification of polyps at baseline or week 28 colonoscopy5. For Part 2 only: Prior total or subtotal resection of the colon or another prior surgical procedure preventing colonoscopy.6. Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors (eg, ibuprofen, naproxen, celecoxib), defined as ≥3 doses per week for a duration of ≥4 weeks within the past 6 months, unless discontinued at least 4 weeks prior to Screening. Use of aspirin is permitted but must be documented (note that for subjects in Part 2 on anti-platelet and anticoagulant therapy, Exclusion Criterion #15 must be followed. 7. Immunosuppressive doses of systemic steroids or absorbed topical steroids (doses >10 mg prednisolone (prednisone) daily equivalent) within 2 weeks before study intervention administration or currently requiring maintenance doses of >10 mg prednisolone (prednisone) or equivalent per day.8. History of primary immunodeficiency or solid organ transplantation.9. Any history of live or live attenuated vaccinations within 28 days prior to cycle 1 day 1 (C1D1), i.e., the first dose of study treatment. Recent non-live vaccines (including mRNA vaccines) are permitted but should not be administered within 14 days prior to study dose. 10. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.11. Major surgical procedures ≤28 days or non‑study‑related minor procedures ≤7 days prior to C1D1. In all cases, the participant must be sufficiently recovered and stable before treatment administration.12. Any of the following cardiac abnormalities:12.1. Medically uncontrolled hypertension12.2. New York Heart Association Class III or IV cardiac disease12.3. Myocardial infarction within prior 6 months12.4. Unstable angina pectoris12.5. Unstable arrhythmias or prolonged corrected QT interval (QTc) >450 ms in males or >470 ms in females (unless a pacemaker is in place)13. Has an active bacterial infection requiring use of systemic antibiotics or an active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBsAg result), or hepatitis C. Participants with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Human immunodeficiency virus (HIV)-positive participants with CD4 count ≥350 cells/mm3 and an undetectable HIV viral load within the past year (low level variations from 50-500 viral copies which do not lead to changes in antiretroviral therapy) are eligible.14. Active gastrointestinal bleeding or haemoptysis15. For Part 2 only: Use of antiplatelet or anticoagulation therapy that cannot be safely stopped peri-colonoscopy for the durations specified in the BSG/ESG16. Any unstable or clinically significant concurrent medical condition, psychiatric illness, substance abuse, or social situation that would limit compliance with study requirements or compromise the ability of the participant to provide written informed consent, per the discretion of the Investigator.17. Previous exposure to an investigational preventative cancer vaccine.18. Has concurrent enrolment in another clinical study (unless it is an observational/noninterventional clinical study).
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Oxford and funded by Moderna.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
