STARKAP Protocol: preliminary assessment of safety and tolerability of dostarlimab in combination antiretroviral therapy (cART)-refractory HIV associated Kaposi’s Sarcoma

The trial will enrol 20 patients in total. After completion of the screening procedures, participants will receive the first dose of dostarlimab within 28 days. Dostarlimab will be administered at the dose of 500 mg evry 3 weeks for the first 5 cycles, and at 1000 mg every 6 weeks thereafter. Treatment will continue until disease progression, unacceptable toxicity, or completion of 1 year of treatment. The first 6 patients will be enrolled in a safety-lead-in phase, if no dose-limiting toxicities (DLTs) will occur within the 21 days in the first 6 participants, trial will continue. Patients will be monitored for the emergence of adverse events until 90 days after the last dose of treatment. Tumour response will be assessed as objective response rate (ORR) at cycle 4, cycle 8 and end of treatment. Tissue, bloods, and stool samples will be collected at baseline, on treatment and at end of treatment to satisfy the related translation plan.