Clinical trial · Interventional
Cytokine-induced Killer Study for Patients With Stage II Melanoma
A Study of Ipilimumab Plus Cytokine-induced Killer Immunotherapy for Stage II Melanoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytokine-induced killer cells | Biological | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IP plus CIK
- description
- Patients receive ipilimumab and CIK.
- interventionNames
- Biological: Cytokine-induced killer cells
- Drug: Ipilimumab
- type
- ACTIVE_COMPARATOR
- label
- IP alone
- description
- Patients receive ipilimumab alone.
- interventionNames
- Drug: Ipilimumab
Primary outcomes (2)
- measure
- Overall survival (OS)
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of melanoma. AJCC Stage IV (any T, any N, M1), metastatic, progressive, refractory, melanoma. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. Serum albumin ≥3.0 gm/dL. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available