Cytokine-induced Killer Study for Patients With Stage II Melanoma

ConditionMelanoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First People's Hospital of Changzhou

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Histological diagnosis of melanoma. AJCC Stage IV (any T, any N, M1), metastatic, progressive, refractory, melanoma.

Disqualifiers

Age <18-years-old. Active CNS metastases or carcinomatous meningitis. Patients with CNS lesions that have been treated and who have no evidence of progression in the brain on CT/MRI for ≥1 month are eligible. Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cytokine-induced killer cells

    Biological/Vaccine

    CIK cells are transferred every 3 months for 1 year.

  • Ipilimumab

    Drug

    Ipilimumab are delivered every 3 weeks for one year

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: IP plus CIKExperimental treatment 2 interventions
Group B: IP aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time frame
5 years
2

Progression Free Survival (PFS)

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: