Abstract 1555TiP
Background
Classic Kaposi’s sarcoma (CKS) is a cutaneous neoplasm of endothelial origin, caused by chronic human herpes virus-8 (HHV-8) infection combined with an impaired immune function status. Systemic treatment of CKS is based on chemotherapy (CT), resulting in 30%–50% of transient responses. There is a strong clinical need to assess the efficacy of new drugs for treatment of CKS. Pilot studies of anti-programmed cell death protein 1 (PD1) antibodies in CKS have shown promising results. Beside immunodeficiency status, HHV8 viral genes contribute to tumorigenesis through the VEGF signaling pathways. Positive results of the combination of the anti-PD1 antibody, pembrolizumab, with the anti-angiogenic drug, lenvatinib, are supported by a strong biologic rationale and have been demonstrated in several ongoing clinical trials in different types of solid tumors.
Trial design
This is a single-arm phase II trial evaluating the role of pembrolizumab and lenvatinib in recurrent CKS. Main inclusion criteria include: histologically confirmed diagnosis of CKS, and progression or inadequate response to ≥1 prior CT. Exclusion criteria include known human immunodeficiency virus (HIV) infection. The primary endpoint of the trial is objective response rate (ORR). Secondary endpoints include duration of response (DOR), progression-free (PFS), overall survival (OS), tolerability and safety. Exploratory endpoints include evaluation of HHV8 DNA plasma levels, PD-L1 and tumor infiltrating lymphocytes in tumor specimens at baseline and at the time of treatment discontinuation. The estimated sample size of the trial is 25 patients, over a 24-month enrollment period. The trial is currently ongoing, and is the first clinical trial assessing the role of pembrolizumab in combination with lenvatinib for treatment of recurrent CKS.
Clinical trial identification
EudraCT 2020-004426-36; Protocol number MK 3475-B60.
Editorial acknowledgement
Legal entity responsible for the study
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan.
Funding
MSD.
Disclosure
All authors have declared no conflicts of interest.