Preventive Dendritic Cell Vaccination for Lynch Syndrome Carriers
ConditionLynch Syndrome
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age35-75
SponsorRadboud University Medical Center
About this trial
The primary objective is to assess the effect of vaccination with neopeptide-loaded dendritic cells on disease-free survival (DFS) compared to placebo in LS subjects who are known to be carrier of a germline MMR-gene mutation with no signs of disease.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Arm A: DC vaccination
- Arm B: Placebo vaccination
Treatment groups
372 Participants
are divided into 2 treatment groupsSponsors and collaborators
Radboud University Medical Center
Lead sponsor
Dutch National Health Care Institute
Collaborator
Source ClinicalTrials.gov