study of pembrolizumab in classic or endemic Kaposi’s sarcoma
- Conditions
- Kaposi's sarcoma
- Registration Number
- 2024-514241-10-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
to assess whether pembrolizumab is clinically inactive (partial+complete response probability π0<5%) or truly active (partial+complete response probability π1>30%) in classic and endemic Kaposi’s sarcoma (KS), using the Simon’s 2 stage Optimal Design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 37
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.
• Has a known history of organ transplantation
• Has active autoimmune disease that has required systemic treatment in the past 2 years
• Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Has KS with symptomatic visceral involvement unless no other therapeutic option is available
• 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.
• 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
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 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.
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. 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.
- Secondary Outcome Measures
Name Time Method Response rate according to ACTG and PGA criteria 6 months Best overall response rate according to Physical Global Assessment (PGA) 6 months 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 to progression 6 months Response rate on number of lesions 6 months Response rate on number of lesions and at best response as defined following ACTG criteria
Response rate on the size of target lesions 6 months Response rate on the size of target lesions and at best response as defined following ACTG criteria
Response rate on tumor infiltration of target lesions 6 months Response rate on tumor infiltration of target lesions and at best response as defined following ACTG criteria
Response rate on lymphedema 6 months 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 to response 6 months Time to response defined as the time to first response recorded from the start of treatment
Trial Locations
- Locations (7)
Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷Toulouse Cedex 9, France
Centre Hospitalier Universitaire De Nice
🇫🇷Nice, France
Hospices Civils De Lyon
🇫🇷Pierre Benite, France
Centre Hospitalier Universitaire De Lille
🇫🇷Lille Cedex, France
Centre Hospitalier Universitaire De Montpellier
🇫🇷Montpellier Cedex 5, France
Centre Hospitalier Regional De Marseille
🇫🇷Marseille, France
Assistance Publique Hopitaux De Paris🇫🇷Paris, FranceCeleste LEBBESite contact0142494679celeste.lebbe@aphp.frFlorence Brunet- PossentiSite contact0140258429florence.brunet-possenti@aphp.frEve MaubecSite contact0148957090eve.maubec@aphp.frNicolas DUPINSite contact0156560053nicolas.dupin@aphp.fr