Clinical trial of combined therapy with pembrolizumab and lenvatinib for patients with classic Kaposi sarcoma treated with at least one previous line of chemioterapy.

Phase 2

Not yet recruiting

• Conditions: Advanced unresectable classic Kaposi sarcoma relapsed and/or refractory to previous standard treatments.

• Registration Number: 2024-512834-14-00
• Lead Sponsor: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 25

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.		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 Outcome Measures

Name	Time	Method
To estimate the duration of response (DOR) in patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib		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 progression free survival (PFS);
to estimate the overall survival (OS);		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 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 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 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 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)		to analyze PD-L1 and VEGF expression, and tumor infiltrating lymphocytes in tumor specimens at baseline and at the time of disease progression (optional)

Trial Locations

Locations (1)

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

🇮🇹Milan, Italy

Ornella Garrone

Site contact

0255032666

ornella.garrone@policlinico.mi.it