Combining radiation therapy with immunotherapy for metastatic uveal melanoma
A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
This study is testing if combining radiation therapy with a new immunotherapy can help people with metastatic uveal melanoma feel better and respond to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | California Pacific Medical Center Research Institute Academic / other |
| Drugs / interventions | relatlimab, radiation, nivolumab, immunotherapy |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05077280 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial investigates the combination of stereotactic body radiotherapy (SBRT) and immunotherapy using Opdualag (nivolumab and relatlimab) for patients with metastatic uveal melanoma. Patients will receive SBRT in three doses of 15Gy each to target 1-5 metastases, while Opdualag will be administered every four weeks for up to two years. The study aims to evaluate the safety, tolerability, and response rates using iRECIST criteria, enrolling up to 50 patients. This approach seeks to explore the potential synergistic effects of combining radiation and immunotherapy in a condition with limited standard treatment options.
Who should consider this trial
Good fit: Ideal candidates include individuals with measurable metastatic uveal melanoma who meet specific health criteria and have not received certain prior therapies.
Not a fit: Patients with extensive liver tumor volume, active CNS metastases, or those who have previously received Opdualag or relatlimab may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic uveal melanoma.
How similar studies have performed: While there is limited data on this specific combination, previous studies have shown promise in using radiation and immunotherapy for various cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- California Pacific Medical Center Research Institute — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Madeline Decker
- Email: KimKB@sutterhealth.org
- Phone: 4156006000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.