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MIND-DC: nDC Vaccination in Stage IIIB/IIIC Melanoma
NCT02993315Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2016
- Primary completion
- Jan 2024
- Countries
- 1
- Sponsor
- Radboud University Medical Center
- Conditions
- melanoma
01
Overview
Phase 3, randomised, double-blind trial in melanoma comparing nDC vaccination arm with placebo arm (2 arms). Primary endpoint: Recurrence-Free Survival at 2 years. Started Oct 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
nDC vaccination arm
Active immunization with autologous natural dendritic cells pulsed with synthetic peptides.
placebo arm
Matching placebo injections.
03
Who it enrols
Adults with resected Stage IIIB/IIIC cutaneous melanoma, WHO performance status 0-1, no distant metastases, and no history of autoimmune disease or recent second malignancies.
04
Endpoints
Primary
Recurrence-Free Survival
Secondary
Overall Survival
Tumor specific T-cell response
Quality of Life
Costs of treatment
Quality-Adjusted Life Year
Adverse Events related to treatment
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