Advanced unresectable classic Kaposi sarcoma relapsed and/or refractory to previous standard treatments. MedDRA version: 20.0 Level: PT Classification code 10023284 Term: Kaposi's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10023284 Term: Kaposi's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Lenvatinib
Product Code: [E7080/MK7902]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenvatinib Mesilato
CAS Number: 857890-39-2
Current Sponsor code: Lenvatinib
Other descrip
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 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); has had an allogeneic tissue/solid organ transplant; 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; previous immunotherapy with ICI(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objective of the study include the evaluation of the duration of response; evaluation of the impact of combination therapy on survival; treatment tolerability in this patients’ subgroup (including evaluation of the incidence of treatment related adverse events, and the impact of treatment on the patients’ quality of life).;Primary end point(s): The primary endpoint of the study is to estimate the overall response rate (ORR) during treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory classic Kaposi sarcoma.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To estimate the duration of response (DOR) in patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib; to estimate the progression free survival (PFS); to estimate the overall survival (OS); to estimate the mean change from baseline in the global health status/quality of life (QoL), and physical functioning for the combinations of pembrolizumab and lenvatinib; to estimate the safety and tolerability for the combination of pembrolizumab and lenvatinib; to evaluate changes in plasma levels of HHV8 DNA at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity); to evaluate changes in plasma levels of circulating markers (i.e. PD-1/PD-L1, VEGF, VEGF-R) at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity); to analyze PD-L1 and VEGF expression, and tumor infiltrating lymphocytes in tumor specimens at baseline and at the time of disease progression (optional).;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Italy
Contacts
Public ContactUOC Oncologia Medica
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Outcome results
None listed