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

Sponsor: California Pacific Medical Center Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05077280

Patient View

This phase 2 trial evaluates the safety and tolerability of combining SBRT and Opdualag for metastatic uveal melanoma. SBRT targets 1-5 metastases with 45Gy total, while Opdualag is administered every 4 weeks for two years. Eligible patients have measurable disease, no active CNS metastases, and meet specific lab criteria. Exclusions include liver tumor volume >50% and prior Opdualag therapy.

Patient Parameters

Program 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

Description

Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with Opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to <15Gy. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.

Eligibility Criteria

Inclusion 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

Exclusion Criteria

  • 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

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