A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)
A prospective, single arm, interventional study. All patients will receive IV nivolumab 3mg/kg every two weeks and ipilimumab 1mg/kg every 6 weeks. Patients will be treated until disease progression or intolerable toxicity for a maximal period of two years, with an option to re-initiate therapy upon progression in patients with prior documented response to investigational therapy (unless treatment was held for progression of disease).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
nivolumab 240mg every 2 weeks
ipilimumab 1 mg/kg every 6 weeks
Rabin Medical Center
Petah Tikva, Israel
RECRUITINGORR
overall response rate (ORR)
Time frame: 6-months
PFS rate
6-months PFS rate
Time frame: 6-months
Safety - Incidence of Treatment-Emergent Adverse Events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE v4)
Patients will be evaluated for treatment related adverse events (AEs) on each visit during study participation and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE v4).
Time frame: during the study, through study completion, an average of 1 year
Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation
Patients will be evaluated for treatment related adverse events (AEs) that caused study drug interrupption and discontinuation.
Time frame: during the study, through study completion, an average of 1 year
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