Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma

Status Completed

Clinical Trial Summary

There is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS). Radiation and injection of vinblastine both have side effects that may not be acceptable. Nivolumab has been used to treat more extensive KS when given intravenously. This is, to the investigators' knowledge, the first trial to see if nivolumab can be used as treatment in the form of an injection into KS lesion.

Clinical Trial Description

Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably plays a permissive role in the development, progression and recurrence of these virus-associated cancers and pre-cancers. Currently, available treatment options for these lesions are imperfect. The goal of this study is to determine whether intra-lesional injections of nivolumab can enhance specific T cell responses in vitro and enhance activity against these virus-associated lesions. Chronic viral infections generate "exhausted" CD8+ T cells with a diminished capacity to produce cytokines and to lyse infected cells. The PD-1 (program death-1)/PD-L1 (program death ligand-1) pathway implicated in the balance between immune eradication and immune escape. This study will evaluate the safety, tolerability, and potential benefits of injecting nivolumab into KS in HIV-infected and HIV-uninfected individuals every 2 weeks for total of 4 doses. The investigators believe this mode of treatment is feasible and tolerable by avoiding the systemic autoimmune adverse events caused by systemic injection of nivolumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03316274
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Completed
Phase	Early Phase 1
Start date	May 7, 2018
Completion date	June 30, 2021

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