NCT03316274

Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma

Phase 1 Study to Evaluate the Safety, Feasibility and Immunologic Correlatives of Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 and 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. To the best of the investigator's knowledge, this is the first study to evaluate the safety of intra-lesional injections of nivolumab in patients with KS.

Detailed description

This is a single-center, phase I safety/expansion trial of nivolumab in HIV-infected (with stable, treated HIV on cART) and HIV-uninfected patients with limited cutaneous KS. PRIMARY OBJECTIVES: \- To determine the safety and tolerability of four intra-lesional injections of nivolumab given every two weeks to treat KS. They will be assessed by NCI Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v. 5). SECONDARY OBJECTIVES: * To determine the changes in cytotoxic T cells and regulatory T cells in the lesions as determined by immunohistochemistry and flow cytometry. * To determine the changes in cytotoxic T cells and regulatory T cells in the peripheral blood as determined by flow cytometry. * To determine the changes in PD-1/PD-L1 expression as determined by immunohistochemistry in lesions. OUTLINE: Participants with treatment-experienced KS will be enrolled into Cohort A (initial safety cohort). If there are no grade 3 or higher adverse events, enrollment into the expansion cohort (Cohort) B will be available to participants with either treatment-experienced or treatment-naïve KS, including those previously enrolled in the safety cohort. Patients will receive one intra-lesional injection of nivolumab into one cutaneous KS lesion every 2 weeks for up to a total of 4 doses until completed or intolerable toxicity, request to withdraw, or withdrawal per the Principal Investigator. Participants will be followed for an additional 5 months after completing the 4 treatment doses.

Conditions

• Kaposi Sarcoma
• HIV/AIDS
• Immunosuppression

Interventions

Type	Name	Description
DRUG	Nivolumab	Given via intralesional injection

Timeline

• Start date: 2018-05-07
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2017-10-20
• Last updated: 2024-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study