RECRUITING

A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

Official Title

A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma

Quick Facts

Study Start:2021-09-20
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05077280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * measurable metastatic uveal melanoma.
  2. * No concomitant therapy.
  3. * Prior PD1 or tebendafesp allowed.
  4. * Performance status 0-1.
  5. * No active Hepatitis B.
  6. * No known HIV infection.
  7. * WBC\>2000, ANC\>1500, Hgb \>8.
  8. * Creatinine \< 3 x ULN.
  9. * AST \& ALT \< 2.5 x ULN Bilirubin \< 2 x ULN.
  10. * Albumin \>2.9
  1. * Liver tumor volume \> 50%.
  2. * Active CNS metastases.
  3. * Pregnancy.
  4. * Prior therapy with Opdualag or relatlimab
  5. * Certain autoimmune diseases.
  6. * Previous liver embolization or radiation.
  7. * Use of systemic steroids

Contacts and Locations

Study Contact

Madeline Decker
CONTACT
4156006000
KimKB@sutterhealth.org

Principal Investigator

David R Minor, MD
STUDY_CHAIR
California Pacific Med Center Research Inst.

Study Locations (Sites)

California Pacific Medical Center Research Institute
San Francisco, California, 94115
United States

Collaborators and Investigators

Sponsor: California Pacific Medical Center Research Institute

  • David R Minor, MD, STUDY_CHAIR, California Pacific Med Center Research Inst.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-20
Study Completion Date2026-03

Study Record Updates

Study Start Date2021-09-20
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • metastatic

Additional Relevant MeSH Terms

  • Uveal Melanoma