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NOT YET RECRUITING
NCT07609901
PHASE3

Preventive Dendritic Cell Vaccination for Lynch Syndrome Carriers

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Prevention of Tumour Occurrence by Targeting Emergent Cancer Neoantigens Through Therapeutic Vaccination in Lynch Syndrome Carriers: a Phase III Clinical Trial.

Key Details

Gender

All

Age Range

35 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2026-10-01

Completion Date

2032-10-01

Last Updated

2026-05-27

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Arm A: DC vaccination

Subjects in the DC vaccination arm will receive a maximum of 2 cycles each consisting of 3 DC injections intranodally (3-7x10\^6 DC)

BIOLOGICAL

Arm B: Placebo vaccination

Subjects in the placeb vaccination arm will receive a maximum of 2 cycles each consisting of 3 placebo injections intranodally (3-7x10\^6 DC)

Locations (1)

Radboudumc

Nijmegen, Gelderland, Netherlands