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

Prior treatment

• has had an allogeneic tissue/solid organ transplant;
• previous immunotherapy with ICI(s).

Other illness

• 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;

• 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.