Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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