Advanced unresectable classic Kaposi sarcoma relapsed and/or refractory to previous standard treatments.
Conditions
Brief summary
The primary endpoint of the study is to estimate the overall response rate (ORR) during treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory classic Kaposi sarcoma.
Detailed description
To estimate the duration of response (DOR) in patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib, to estimate the progression free survival (PFS);, to estimate the overall survival (OS);, to estimate the mean change from baseline in the global health status/quality of life (QoL), and physical functioning for the combinations of pembrolizumab and lenvatinib;, to estimate the safety and tolerability for the combination of pembrolizumab and lenvatinib, to evaluate changes in plasma levels of HHV8 DNA at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity), to evaluate changes in plasma levels of circulating markers (i.e. PD-1/PD-L1, VEGF, VEGF-R) at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity), to analyze PD-L1 and VEGF expression, and tumor infiltrating lymphocytes in tumor specimens at baseline and at the time of disease progression (optional)
Interventions
DRUGLenvatinib
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to estimate the overall response rate (ORR) during treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory classic Kaposi sarcoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the duration of response (DOR) in patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib, to estimate the progression free survival (PFS);, to estimate the overall survival (OS);, to estimate the mean change from baseline in the global health status/quality of life (QoL), and physical functioning for the combinations of pembrolizumab and lenvatinib;, to estimate the safety and tolerability for the combination of pembrolizumab and lenvatinib, to evaluate changes in plasma levels of HHV8 DNA at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity), to evaluate changes in plasma levels of circulating markers (i.e. PD-1/PD-L1, VEGF, VEGF-R) at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity), to analyze PD-L1 and VEGF expression, and tumor in | — |
Countries
Italy
Outcome results
None listed