study of pembrolizumab in classic or endemic Kaposi’s sarcoma

Korábbi kezelés

• Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Previously received treatments with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
• Has had a prior anti-cancer monoclonal antibody (mAb) within last 4 weeks or who has not recovered (i.e., > Grade 1 at selection) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks (or 5 half lives) prior to study Day 1 or who has not recovered (i.e., > Grade 1 at selection) from adverse events due to a previously administered agent

Más betegség

• Has a known history of organ transplantation
• Has active autoimmune disease that has required systemic treatment in the past 2 years
• Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
• Has an active infection requiring systemic therapy
• Has hypersensitivity to pembrolizumab/ KEYTRUDA® or any of its excipients

Egyéb

• Has KS with symptomatic visceral involvement unless no other therapeutic option is available

• Classic or endemic histologically confirmed KS
• Progressive disease
• KS with more than 10 lesions or involving more than one limb segment or with involvement >3% body surface
• .KS with at least 4 lesions>ou = 5mm
• KS with at least 1 other cutaneous tumor available for repeated pharmacodynamics evaluation and be willing to provide tissue from cutaneous biopsy of a tumor lesion
• At least 4 weeks washout for all KS specific therapies including chemotherapy and immunotherapy such as Interferon
• Be 18 years of age on day of signing informed consent
• Female subject of childbearing potential should have a negative serum XML File Identifier: IeulZ03EWkX0or3jxMs6iTJnYtU= Page 10/22 pregnancy within 72 hours prior to receiving the first dose of study medication, and a negative urine pregnancy test prior to receiving each other dose.