Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases

Part of paid clinical trials in San Francisco, California.

Sponsor
David Minor, MD
Study ID
NCT02913417
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Hepatic Metastases
  • Uveal Melanoma

Eligibility Criteria

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

Interventions

  • SIR-Spheres® Yttrium 90 — DEVICE
    Patient treatment will consist of three parts: first, selective internal radiation with SIR-Spheres Yttrium-90 microspheres with dosage per package insert , reduced to give 35cGymax to normal liver; second, concurrent ipilimumab 1mg/kg and nivolumab 1mg/kg every 3 weeks for 4 doses (immunotherapy part 1); then maintenance nivolumab at 480 every 2 weeks (immunotherapy part 2) until progression or 3 years
  • ipilimumab — DRUG
    ipilimumab 1mg/kg every 3 weeks x 4
  • nivolumab — DRUG
    nivolumab 3mg/kg every 3 weeks x 4 then 480mg q 4 weeks

Study Details

Reports to date show limited efficacy of immunotherapy for uveal melanoma. Recent experimental and clinical evidence suggests synergy between radiation therapy and immunotherapy. The investigators will explore this synergy with a feasibility study of 26 patients with uveal melanoma and hepatic metastases who will receive SirSpheres Yttrium-90 selective internal hepatic radiation followed by immunotherapy with the combination of ipilimumab and nivolumab.

Key Dates

Start date
Oct 10, 2016
Status verified
Apr 2021
Primary completion
Jan 31, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: hepatic radiation followed by immunotherapy
    SIR-Spheres Yttrium 90 will be given by injection into the hepatic artery in two treatments, one for each lobe. 3-5 weeks later patients receive concurrent ipilimumab 1mg/kg q 3 wk x 4 and nivolumab 3mg/kg q 3 weeks x 4, all followed by nivolumab 240mg/kg q 2 weeks or 480 mg q 4 weeks until progression or 3 years

Primary Outcome Measure

safety and tolerability of sequential selective internal radiation with Yttrium90 followed by immunotherapy with ipilimumab and nivolumab. [ Time Frame: 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
California Pacific Medical CenterSan FranciscoCalifornia94115-
University of ChicagoChicagoIllinois60637-
Jefferson Medical College of Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in San Francisco, CA

By research site
California Pacific Medical Center· San Francisco, CAUniversity of Chicago· Chicago, ILJefferson Medical College of Thomas Jefferson University· Philadelphia, PA

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