Clinical trial of combined therapy with pembrolizumab and lenvatinib for patients with classic Kaposi sarcoma treated with at least one previous line of chemioterapy.
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Trial code
- EU 2024-512834-14-00
- Record updated
- 2024. december 2.
- Original description
The main objective of the study is to evaluate the response rate to the treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory Kaposi sarcoma.Read full original descriptionShow less
A Phase II single-arm study of pembrolizumab plus lenvatinib in previously treated classic Kaposi sarcoma (CKS)
The main objective of the study is to evaluate the response rate to the treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory Kaposi sarcoma.
Inclusion: Histologic diagnosis of classic Kaposi sarcoma; progression, relapse or inadequate response to at least one prior systemic chemotherapy; presence of measurable disease by Positron Emission Tomography-Computed Tomography (PET-CT) scan and/or dermatological examination; at least 1 superficial lesion willing to provide tissue from cutaneous and/or mucosal biopsy at baseline; be = 18 years of age at the time of signing informed consent; have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days before the first dose of study intervention; have adequate bone marrow, liver and renal function; have adequately controlled blood pressure.
Exclusion: has had an allogeneic tissue/solid organ transplant; previous immunotherapy with ICI(s); Has a known history of human immunodeficiency virus (HIV) infection, of active infectious hepatitis type B (hepatitis B surface antigen [HBsAg] detected) or C (hepatitis C virus [HCV] ribonucleic acid [RNA] detected) or active Tuberculosis Bacillus (TB); presence of known additional malignancy that is progressing or requires active treatment; has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); significant cardiovascular impairment within 12 months of the first dose of study intervention; history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.