Melanoma Patients Immunized With Natural DenDritic Cells (MIND-DC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02993315|
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: nDC vaccination Biological: placebo injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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.|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2021|
Experimental: nDC vaccination arm
Patients in the nDC vaccination arm will receive a maximum of 3 cycles each consisting of 3 nDC injections intranodally (3-8x10^6 nDC).
Biological: nDC vaccination
Placebo Comparator: placebo arm
Patients will receive a maximum of 3 cycles each consisting of 3 placebo injections intranodally.
Biological: placebo injection
- 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.
- Recurrence-free survival [ Time Frame: 2 years and 5 years ]Median RFS duration will be assessed by physical examination and CT of the chest and abdomen every 3-12 months, or on clinical indication, during 5 years.
- Overall survival [ Time Frame: 2-years and median ]
- Tumor specific T-cell response [ Time Frame: week 1, week 9, week 10, week 31, week 39, week 57, week 65, week 78, month 24, month 60 ]
- Quality of Life Questionnaires [ Time Frame: baseline, week 14, week 26, month 12, month 24, month 36, month 60 ]
- Costs (direct and indirect) of treatment [ Time Frame: 2 years ]
- QALY [ Time Frame: 2 years ]A cost-effectiveness acceptability curve will be derived that is able to evaluate efficiency by using different tresholds (willingness to pay) for a QALY.
- Adverse Events related to treatment [ Time Frame: 1,5 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993315
|Contact: Winald Gerritsen, Prof. MD.||+31243618800||MINDstudie.TIL@radboudumc.nl|
|Contact: Martine Bloemendal, MD||+31243618800||MINDstudie.TIL@radboudumc.nl|
|NKI-AvL||Not yet recruiting|
|Contact: John Haanen, Prof. MD.|
|VUmc||Not yet recruiting|
|Contact: Alfons van den Eertwegh, MD|
|Contact: Winald Gerritsen, Prof. MD. +31243618800 MINDstudie.TIL@radboudumc.nl|
|ErasmusMC||Not yet recruiting|
|Contact: Willem Kruit, MD|
|Contact: Jan Willem de Groot, MD.|
|Principal Investigator:||Jolanda de Vries, Prof. dr.||Radboud University|