Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies. Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples have been recently reported. Our experience in classical and endemic KS supports the role of this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS lesions. In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and endemic KS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Route: intravenous infusion Dose regimen: 200 mg per infusion every 3 weeks Duration of treatment: 6 months (8 cycles)
Saint-Louis Hospital
Paris, France
RECRUITINGBest Overall Response Rate (BORR)
Best Overall Response Rate (BORR) defined by the occurrence of complete response or partial response following AIDS Clinical Trials Group (ACTG) criteria recorded from the start of treatment until 6 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months
Time frame: 6 months
Best overall response rate according to Physical Global Assessment (PGA)
Best overall response rate according to Physical Global Assessment (PGA) score until 6 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months
Time frame: 6 months
Response rate according to ACTG and PGA criteria
Time frame: 3 months
Response rate according to ACTG and PGA criteria
Time frame: 6 months
Response rate on number of lesions
Response rate on number of lesions and at best response as defined following ACTG criteria
Time frame: 3 months
Response rate on number of lesions
Response rate on number of lesions and at best response as defined following ACTG criteria
Time frame: 6 months
Response rate on the size of target lesions
Response rate on the size of target lesions and at best response as defined following ACTG criteria
Time frame: 3 months
Response rate on the size of target lesions
Response rate on the size of target lesions and at best response as defined following ACTG criteria
Time frame: 6 months
Response rate on tumor infiltration of target lesions
Response rate on tumor infiltration of target lesions and at best response as defined following ACTG criteria
Time frame: 3 months
Response rate on tumor infiltration of target lesions
Response rate on tumor infiltration of target lesions and at best response as defined following ACTG criteria
Time frame: 6 months
Response rate on lymphedema
Response rate on lymphedema (circumference, scale of 0 (absence) to 3 (painful or oozing)) at Month 3, Month 6 and at best response as defined following ACTG criteria
Time frame: 3 months
Response rate on lymphedema
Response rate on lymphedema (circumference, scale of 0 (absence) to 3 (painful or oozing)) at Month 3, Month 6 and at best response as defined following ACTG criteria
Time frame: 6 months
Time to response
Time to response defined as the time to first response recorded from the start of treatment
Time frame: 6 months
Time to progression
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.