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Melanoma Patients Immunized With Natural DenDritic Cells (MIND-DC)

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ClinicalTrials.gov Identifier: NCT02993315
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
Zorginstituut Nederland
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE November 23, 2016
First Posted Date  ICMJE December 15, 2016
Last Update Posted Date July 25, 2018
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Recurrence-free survival rate [ Time Frame: 2 years ]
The primary objective of this study is to determine whether adjuvant nDC vaccination improves 2-year RFS rate as compared to placebo in patients with completely resected stage IIIB or IIIC melanoma, defined as the percentage of patients who are alive and without recurrence of melanoma 2 years after randomization.
Change History Complete list of historical versions of study NCT02993315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melanoma Patients Immunized With Natural DenDritic Cells
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description This is a phase 3, randomized, double-blind, interventional study of nDC vaccination versus placebo. Dendritic cell-based immunotherapy consists of antigen-loaded autologous DC that are administered to patients with the intention of inducing antigen-specific T and B cell responses and proved safe with minimal side effects. Natural DC (nDC) consist of plasmacytoid DC and myeloid DC. Subjects will be randomized 2:1 and stratified by stage of disease, adjuvant radiotherapy, BRAF mutation status, HLA-type and nDC production centre. The treatment will be continued for a maximum of 1.5 years or until recurrence of disease, unacceptable toxicity or withdrawal from the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Biological: nDC vaccination
  • Biological: placebo injection
Study Arms  ICMJE
  • 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).
    Intervention: Biological: nDC vaccination
  • Placebo Comparator: placebo arm
    Patients will receive a maximum of 3 cycles each consisting of 3 placebo injections intranodally.
    Intervention: Biological: placebo injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
210
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Winald Gerritsen, Prof. MD. +31243618800 MINDstudie.TIL@radboudumc.nl
Contact: Martine Bloemendal, MD +31243618800 MINDstudie.TIL@radboudumc.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02993315
Other Study ID Numbers  ICMJE NL55823.000.15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • Zorginstituut Nederland
  • ZonMw: The Netherlands Organisation for Health Research and Development
Investigators  ICMJE
Principal Investigator: Jolanda de Vries, Prof. dr. Radboud University
PRS Account Radboud University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP