Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03316274
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Given via intralesional injection

Study Details

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.

Key Dates

Start date
May 7, 2018
Status verified
Jun 2024
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab (Cohort A-Safety)
    Participants will receive a 10mg (or 1 mL) injection into a single KS lesion in the skin, every 2 weeks for 4 doses.
  • Experimental: Nivolumab (Cohort B-Expansion)
    Participants from Cohort A with at least 1 lesion that is left untreated and additional participants receive injections in into up to 2 KS lesions in the skin, every 2 weeks for 4 doses. The injected volume will not exceed 10 mg (or 1 mL) each time. Lesions will be evaluated at week 26, and participants with lesion improvement may enroll in Cohort B-PLUS to receive additional injections.
  • Experimental: Nivolumab (Cohort B-PLUS)
    Participants in Cohort B whose injected lesions achieved partial response or complete response by week 26 and who did not experience any serious adverse events, are permitted to receive additional injections up to 4 residual KS lesions (total volume 10 mg in 1 mL) every 2 weeks for up to 4 additional doses. Lesions will be assessed again after 26 weeks.

Primary Outcome Measure

Number participants with Dose Limiting Toxicities (DLT) (Cohort A) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110-

Find similar trials in San Francisco, CA

By condition
HIV
By specialty
Infectious disease
By research site
Zuckerberg San Francisco General Hospital· San Francisco, CA

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