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

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

Conditions

Uveal Melanoma

Study Overview

Study Details

Study overview

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

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

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

Condition
Uveal Melanoma
Intervention / Treatment

-

Contacts and Locations

San Francisco

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * measurable metastatic uveal melanoma.
  • * No concomitant therapy.
  • * Prior PD1 or tebendafesp allowed.
  • * Performance status 0-1.
  • * No active Hepatitis B.
  • * No known HIV infection.
  • * WBC\>2000, ANC\>1500, Hgb \>8.
  • * Creatinine \< 3 x ULN.
  • * AST \& ALT \< 2.5 x ULN Bilirubin \< 2 x ULN.
  • * Albumin \>2.9
  • * Liver tumor volume \> 50%.
  • * Active CNS metastases.
  • * Pregnancy.
  • * Prior therapy with Opdualag or relatlimab
  • * Certain autoimmune diseases.
  • * Previous liver embolization or radiation.
  • * Use of systemic steroids

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

California Pacific Medical Center Research Institute,

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

Study Record Dates

2026-03