NCT02498756Not yet recruitingPhase 2
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 · Last updated 15 Jul 2015 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 30 Jun 2015
- Start date
- 1 Aug 2015
- Primary completion date
- 31 Aug 2038
- Lead sponsor
- The First People's Hospital of Changzhou
- Diseases
- Melanoma
- NCT number
- NCT02498756
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 1 Aug 2015 to the primary completion date, 31 Aug 2038
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.