NCT03469804

Phase II Multicentric Study of Pembrolizumab in Classic or Endemic Kaposi's Sarcoma

Essai de Phase II Multicentrique évaluant le Pembrolizumab Dans le Traitement de la Maladie de Kaposi Classique ou endémique

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kaposi Sarcoma
• Progression, Disease

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Route: intravenous infusion Dose regimen: 200 mg per infusion every 3 weeks Duration of treatment: 6 months (8 cycles)

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-03-20
• Completion: 2020-09-20
• First posted: 2018-03-19
• Last updated: 2019-10-21

Locations

1 site across 1 country: France