Recruiting
Phase 2

Opdualag

Sponsor:

California Pacific Medical Center Research Institute

Code:

NCT05077280

Conditions

Uveal Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

stereotactic body radiotherapy

Immunotherapy

Study Details

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

Conditions

Uveal Melanoma

Study ID

NCT05077280

Start date

Sep 20, 2021

Status verified date

Dec, 2022

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: one arm

see below

Interventions

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

Immunotherapy

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

Primary outcome measure

  • safety and tolerability of the therapy [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Madeline Decker

4156006000KimKB@sutterhealth.org

Locations

California Pacific Medical Center Research Institute

Recruiting

San Francisco, California, United States, 94115

Contacts

Madeline Decker

415-600-3613KimB@sutterhealth.org

Principal Investigator:

Kevin B Kim, M.D.

More Information

Sponsor

California Pacific Medical Center Research Institute

Last update posted

Dec 6, 2022

Last verified

Dec, 2022

Keywords

  • metastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by California Pacific Medical Center Research Institute on 2022-12-06.