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

Uveal Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077280
• Other study ID #: 2021.072-2
• Status: Recruiting
• Phase: Phase 2
• Start date: September 20, 2021
• Est. completion date: March 2026

Study information

• Verified date: December 2022
• Source: California Pacific Medical Center Research Institute
• Contact: Madeline Decker
• Phone: 4156006000
• Email: KimKB[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2026
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Radiation:
• stereotactic body radiotherapy
Stereotactic Body radiotherapy will be given to 1-5 target metastases in 3 doses over 8 days or less. Each dose will be 15Gy for a total dose of 45GY

Drug:
• Immunotherapy
Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

Locations

Country	Name	City	State
United States	California Pacific Medical Center Research Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression-free survival	survival without progressive cancer	5 years
Other	Overall survival	survival	5 years
Primary	safety and tolerability of the therapy	toxicity measured by CTAE graded 3-5 toxicities	5 years
Secondary	Response rate	iRECIST defined response rates	5 years