A Phase II single-arm study of pembrolizumab plus lenvatinib in previously treated classic Kaposi sarcoma (CKS)

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico1 site in 1 country25 target enrollmentDecember 2, 2024

DrugsBAT3306 FYB206 Pabolizumab SCH-900475 Lenvatinib KEYTRUDA 25 mg/mL concentrate for solution for infusion ABP 234 Lambrolizumab MK-3475

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Enrollment: 25
Locations: 1
Primary Endpoint: 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.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

euclinicaltrials.eu

Start Date

December 2, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Responsible Party

Principal Investigator

Ornella Garrone

Scientific

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Eligibility 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.

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)