NCT02993315: MIND-DC

A Randomized, Double--blind, Placebo-controlled Phase III Study to Evaluate Active Immunization in Adjuvant Therapy of Patients with Stage IIIB and IIIC Melanoma with Natural Dendritic Cells Pulsed with Synthetic Peptides.

Completed Phase 3 Last updated 30 January 2025

What this trial tests

Phase 3 trial testing nDC vaccination in Melanoma (Skin) in 148 participants. Completed in 1 May 2024.

Timeline

1 October 2016

Primary endpoint
1 January 2024

1 May 2024

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	148
Start date	1 October 2016
Primary completion	1 January 2024
Estimated completion	1 May 2024
Sites	5 locations across Netherlands

Drugs / interventions tested

• nDC vaccination — full drug profile →
• placebo injection

Conditions studied

• Melanoma (Skin) — all drugs for Melanoma (Skin) →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Recurrence-free survival rate
  Time frame: 2 years
  The primary objective of this study is to determine whether adjuvant nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves 2-year RFS rate as compared to treatment with matching placebo. Defined as the percentage of patients who are alive and without recurrence of melanoma 2 years after randomization.
• Treatment of melanoma patients
  Time frame: The primary endpoint, 2-year RFS. At data cutoff, the median duration of follow-up was 56.3 months.
  Adjuvant treatment with nDC vaccination or placebo, after standard treatment

Sponsor's own description

The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves recurrence-free survival (RFS) as compared to treatment with matching placebo.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vaccine Therapies for Cancer: Then and Now.
   Morse MA, Gwin WR, Mitchell DA. · · 2021 · cited 156× · PMID 33512679 · DOI 10.1007/s11523-020-00788-w
2. Personalized Dendritic Cell Vaccines-Recent Breakthroughs and Encouraging Clinical Results.
   Mastelic-Gavillet B, Balint K, Boudousquie C, Gannon PO, et al · · 2019 · cited 145× · PMID 31031762 · DOI 10.3389/fimmu.2019.00766
3. The clinical application of cancer immunotherapy based on naturally circulating dendritic cells.
   Bol KF, Schreibelt G, Rabold K, Wculek SK, et al · · 2019 · cited 135× · PMID 30999964 · DOI 10.1186/s40425-019-0580-6
4. Research progress on dendritic cell vaccines in cancer immunotherapy.
   Yu J, Sun H, Cao W, Song Y, et al · · 2022 · cited 130× · PMID 35074008 · DOI 10.1186/s40164-022-00257-2
5. Induction of Tolerance and Immunity by Dendritic Cells: Mechanisms and Clinical Applications.
   Fucikova J, Palova-Jelinkova L, Bartunkova J, Spisek R. · · 2019 · cited 120× · PMID 31736936 · DOI 10.3389/fimmu.2019.02393
6. Effective cancer immunotherapy by natural mouse conventional type-1 dendritic cells bearing dead tumor antigen.
   Wculek SK, Amores-Iniesta J, Conde-Garrosa R, Khouili SC, et al · · 2019 · cited 108× · PMID 30961656 · DOI 10.1186/s40425-019-0565-5
7. Trial watch: dendritic cell vaccination for cancer immunotherapy.
   Sprooten J, Ceusters J, Coosemans A, Agostinis P, et al · · 2019 · cited 107× · PMID 31646087 · DOI 10.1080/2162402x.2019.1638212
8. Dendritic Cell Cancer Therapy: Vaccinating the Right Patient at the Right Time.
   van Willigen WW, Bloemendal M, Gerritsen WR, Schreibelt G, et al · · 2018 · cited 102× · PMID 30327656 · DOI 10.3389/fimmu.2018.02265