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

NCT02913417 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-04-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

SIR-Spheres® Yttrium 90

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

DRUG

ipilimumab

ipilimumab 1mg/kg every 3 weeks x 4

DRUG

nivolumab

nivolumab 3mg/kg every 3 weeks x 4 then 480mg q 4 weeks

Sponsors & Collaborators

  • California Pacific Medical Center

    collaborator OTHER

  • Jefferson Medical College of Thomas Jefferson University

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • David Minor, MD

    lead OTHER

Principal Investigators

  • David R. Minor, M.D. · California Pacific Medical Center Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2022-01-31
Completion
2023-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02913417 on ClinicalTrials.gov