PEMBROLIZUMAB for Kaposi's sarcoma

Inclusion criteria

• {"criterion_text":"- Classic or endemic histologically confirmed KS"}
• {"criterion_text":"- Progressive disease"}
• {"criterion_text":"- KS with more than 10 lesions or involving more than one limb segment or with involvement >3% body surface"}
• {"criterion_text":"- .KS with at least 4 lesions>ou = 5mm"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- At least 4 weeks washout for all KS specific therapies including chemotherapy and immunotherapy such as Interferon"}
• {"criterion_text":"- Be 18 years of age on day of signing informed consent"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- •\tHas a known history of organ transplantation"}
• {"criterion_text":"- •\tHas active autoimmune disease that has required systemic treatment in the past 2 years"}
• {"criterion_text":"- •\tIs receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment"}
• {"criterion_text":"- •\tHas KS with symptomatic visceral involvement unless no other therapeutic option is available"}
• {"criterion_text":"- •\tPreviously 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."}
• {"criterion_text":"- •\tUncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection."}
• {"criterion_text":"- •\tHas an active infection requiring systemic therapy"}
• {"criterion_text":"- •\tHas hypersensitivity to pembrolizumab/ KEYTRUDA® or any of its excipients"}
• {"criterion_text":"- •\tHas 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."}
• {"criterion_text":"- •\tHas 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"}

Primary endpoints

• {"endpoint_text":"- the Best Overall Response Rate (BORR) defined by the occurrence of complete response or partial response following 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.","definition_or_measurement_approach":"Measured per ACTG criteria; BORR = occurrence of complete or partial response recorded from start of treatment until 6 months or until start of any other systemic therapy if earlier."}
• {"endpoint_text":"- For Extension stage The primary endpoint of this stage will be the best overall response rate according to the ACTG criteria recorded from the start of treatment until 24 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months.","definition_or_measurement_approach":"Measured per ACTG criteria; BORR recorded from start of treatment until 24 months or until start of any other systemic therapy if earlier."}

France

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

560

Number Of Sites

10

Number Of Participants

37

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"MSD International","duties_or_roles":"Monetary support","organisation_type":""}