Clinical trial · Interventional
A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma
A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
NCT05077280CI-TRIAL-00062514unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
| stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- one arm
- description
- see below
- interventionNames
- Radiation: stereotactic body radiotherapy
- Drug: Immunotherapy
Primary outcomes (1)
- measure
- safety and tolerability of the therapy
- timeFrame
- 5 years
- description
- toxicity measured by CTAE graded 3-5 toxicities
Secondary outcomes (1)
- measure
- Response rate
- timeFrame
- 5 years
- description
- iRECIST defined response rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.