NCT01216696

Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1

Phase II Trial of Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: National Center for Tumor Diseases, Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	ipilimumab	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 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 , withdrawal of consent,pregnancy, death or lost to follow up whichever occurs first.

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2010-10-07
• Last updated: 2016-08-12

Locations

1 site across 1 country: Germany