Cytokine-induced Killer Study for Patients With Stage II Melanoma

Sponsor
The First People's Hospital of Changzhou
Study ID
NCT02498756
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Cytokine-induced killer cells — BIOLOGICAL
    CIK cells are transferred every 3 months for 1 year.
  • Ipilimumab — DRUG
    Ipilimumab are delivered every 3 weeks for one year

Study Details

For investigators' current experimental clinical trial, patients are given 4 injections of ipilimumab, given 3 weeks apart x 4 injections with or without cytokine-induced killer therapy. Investigators propose to test this dual therapy in patients with melanoma who have known stage I, metastatic melanoma. Investigators hypothesize that this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage, significant prolongation of progression-free, disease-free or overall survival compared to the use of ipilimumab alone

Key Dates

Start date
Aug 31, 2015
Status verified
Jul 2015
Primary completion
Aug 31, 2038
Completion
Aug 31, 2040

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IP plus CIK
    Patients receive ipilimumab and CIK.
  • Active Comparator: IP alone
    Patients receive ipilimumab alone.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 5 years ]

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