Melanoma Patients Immunized With Natural DenDritic Cells (MIND-DC)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02993315 |
Recruitment Status :
Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : March 15, 2021
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Condition or disease | Intervention/treatment | Phase |
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Melanoma (Skin) | Biological: nDC vaccination Biological: placebo injection | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | October 2016 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
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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).
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Biological: nDC vaccination |
Placebo Comparator: placebo arm
Patients will receive a maximum of 3 cycles each consisting of 3 placebo injections intranodally.
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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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
- at least 18 years of age.
- Histologically confirmed stage III cutaneous melanoma, classified as IIIB or IIIC disease (AJCC 2009). Patients with completely resected in-transit and/or satellite metastases and patients with unknown primary melanoma are allowed in this trial.
- Radical lymph node dissection involved site with complete resection or sentinel node procedure (in case of patients without RLND because of limited sentinel-node positive disease) of melanoma as documented on the operating report and pathology report with at least the minimal levels excised as stated in national guidelines.
- Radical lymph node dissection involved site with complete resection or sentinel node procedure (in case of patients without RLND because of limited sentinel-node positive disease) must be performed within 12 weeks prior to start of study.
- Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
- Absence of distant metastases must be documented by a CT scan of the chest and abdomen (including pelvis) or a Positron Emission Tomography (PET) scan, the scan should have been performed within 6 weeks before surgery or after surgery prior to inclusion. In addition, a physical exam after surgery must be performed also excluding distant metastases.
- No clinical evidence for brain metastasis. If brain metastases are clinically suspected, a CT or Magnetic Resonance Imaging (MRI) scan of the brain must exclude brain metastases.
- World Health Organization (WHO) performance status of 0 or 1 at time of randomization.
- Adequate hematologic, renal and liver function as defined by laboratory values performed within 4 weeks of randomization.
- No second malignancy in the previous 5 years, with the exception of adequately treated carcinoma in-situ and basal or squamous cell carcinoma of the skin.
- No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted.
- No uncontrolled infectious disease, i.e. negative testing for HIV, HBV, HCV and syphilis.
- No autoimmune disease such as, but not limited to, inflammatory bowel disease, multiple sclerosis, and lupus. Patients with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded.
- No serious (bleeding and clotting) condition that may interfere with safe leukapheresis.
- No pregnant or lactating women.
- No Women Of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 8 weeks after the last administration of the treatment. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea > 12 consecutive months].
- Patients must have absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions must be discussed with the patient before registration in the trial.
- Expected adequacy of follow-up.
- Written informed consent.

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
Netherlands | |
NKI-AvL | |
Amsterdam, Netherlands | |
VUmc | |
Amsterdam, Netherlands | |
Radboudumc | |
Nijmegen, Netherlands | |
ErasmusMC | |
Rotterdam, Netherlands | |
Isala klinieken | |
Zwolle, Netherlands |
Principal Investigator: | Jolanda de Vries, Prof. dr. | Radboud University Medical Center |
Responsible Party: | Radboud University Medical Center |
ClinicalTrials.gov Identifier: | NCT02993315 |
Other Study ID Numbers: |
NL55823.000.15 |
First Posted: | December 15, 2016 Key Record Dates |
Last Update Posted: | March 15, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |