Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1 (CTLA4 NY-ESO-1)
This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous preexisting immune response to NY-ESO-1.
Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in patients with melanoma. Thus patients with immunological response to NY-ESO-1 might benefit from an anti CTLA-4 treatment.
Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit (partial response, complete response or stable disease according to the immune-related response criteria) will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression,toxicities requiring discontinuation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1|
- Disease Control Rate according to immune-related response criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]To determine the efficacy of ipilimumab in patients with stage III and stage IV malignant melanoma and spontaneous preexisting immune response to NY-ESO-1.
- Progression-free survival according to the immune-related response criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]To document progression-free survival (PFS) in patients with evaluable or measurable disease after receiving ipilimumab according to the immune-related response criteria (irRC),
- Overall Survival at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]To document overall-survival (OS) rate at 12 months after the first study treatment in patients receiving ipilimumab.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]To assess the safety profile of ipilimumab in patients with malignant melanoma stage III and IV and spontaneous preexisting immune response to NY-ESO-1.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216696
|Contact: Dirk Jaeger, MD||+49-6221-56-5924||Dirk.Jaeger@nct-heidelberg.de|
|NCT, Dep. of Medical Oncology||Recruiting|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Dirk Jäger, MD||NCT Heidelberg, Dep. of Medical Oncology|