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

Phase 2

Recruiting

• Conditions: Uveal Melanoma
• Interventions: Radiation: stereotactic body radiotherapy; Drug: Immunotherapy

• Registration Number: NCT05077280
• Lead Sponsor: California Pacific Medical Center Research Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-09-20
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-06
• Primary Completion: 2024-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one arm	stereotactic body radiotherapy	see below
one arm	Immunotherapy	see below

Primary Outcome Measures

Name	Time	Method
safety and tolerability of the therapy	5 years	toxicity measured by CTAE graded 3-5 toxicities

Secondary Outcome Measures

Name	Time	Method
Response rate	5 years	iRECIST defined response rates

Trial Locations

Locations (1)

California Pacific Medical Center Research Institute; 🇺🇸 San Francisco, California, United States