Personalized vaccine aims to stop lynch syndrome cancers before they start
NCT ID NCT07609901
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase III trial tests whether a vaccine made from a person's own immune cells can prevent cancer in 372 adults with Lynch syndrome, a genetic condition that raises cancer risk. Participants receive either the vaccine or a placebo and are monitored for tumor development. The goal is to see if the vaccine can keep cancer from forming.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 372 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * a confirmed gPV in MLH1 or MSH2 and without a prior history of MMR-D cancer. * a confirmed gPV in MSH6, whether or not they have a history of MMR-D cancer. MSH6 subjects with a history of MMR-D cancer have to be cancer-free for more than 1 year. * previous surgical treatment may include any resection up to and including hemicolectomy; subjects who have undergone (sub)total colectomy are excluded due to the substantially reduced risk of cancer occurrence. * aged between 35 and 75 for subjects with gPV in MLH1 and MSH2; and aged between 40 and 75 for subjects with gPV in MSH6. * Lynch syndrome subjects without clinical signs of disease. * Lynch syndrome subjects without prior treatment for LS-associated cancer, except for MSH6 subjects who are \>1 year disease-free and whose prior surgical treatment did not include subtotal colectomy. * Routine surveillance colonoscopy must be performed within 16 weeks prior to start of study, to exclude (pre)malignancy. * HLA-A02.01 genotype * Adequate hematologic, renal, and liver function as defined by laboratory values: WBC \>3.0\^109/l, lymphocytes \>0.8\^109/l, platelets \>100\^109/l, haemoglobin \>7,0 mmol/l (9.0 g/dl), estimated glomerular filtration rate \> 45 ml/min/1.73m2, AST/ALT \<3 x ULN, serum crea¬tinine \<150 µmol/l, serum bilirubin \<1.5 x ULN (exception: Gilbert's syndrome is permitted). * WHO performance status of 0 or 1 * No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted. * No uncontrolled infectious disease, i.e., negative testing for HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and syphilis (Treponema Pallidum Hemagglutination Assay (TPHA)). * No autoimmune disease such as, but not limited to, inflammatory bowel disease, multiple sclerosis, and lupus. Subjects with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded. * No serious (bleeding and clotting) condition that may interfere with safe leukapheresis. * No pregnant or lactating women. hCG tests will be performed regularly during the trial to confirm absence of pregnancy. * No Women Of Child-Bearing Potential (WOCBP) or male partners of WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 8 weeks after the last administration of the treatment. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea \> 12 consecutive months\]. * Subjects must have absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions must be discussed with the subject before registration in the trial. * Expected adequacy of follow-up. * Written informed consent. Exclusion Criteria: * Individuals with a history of malignancy in the past. Allowed malignancies are adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ (e.g., DCIS/LCIS/cervical CIS), papillary thyroid carcinoma, and low-risk prostate carcinoma; all locally resected with negative surgical margins and not treated with systemic therapy. * Organ allografts. * Known allergy to shellfish. * Inability to understand and communicate in Dutch.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
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Other studies related to the condition(s) this trial covers.
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- Digital assistant aims to close gaps in hereditary cancer care
- Lynch syndrome patients share colonoscopy struggles in new survey
- Swiss study aims to find hidden cancer genes in families
- Could lynch syndrome raise your risk of gum disease?