KAPKEY - Phase II multicentric study of pembrolizumab in classic or endemic Kaposi’s sarcoma
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 37
- Locations
- 7
- Primary Endpoint
- 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.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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 Outcomes
- Response rate according to ACTG and PGA criteria(6 months)
- Time to progression(6 months)
- Best overall response rate according to Physical Global Assessment (PGA)(6 months)
- Response rate on number of lesions(6 months)
- Response rate on the size of target lesions(6 months)
- Response rate on tumor infiltration of target lesions(6 months)
- Response rate on lymphedema(6 months)
- Time to response(6 months)
Investigators
Coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris