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
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | California Pacific Medical Center Research Institute | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
California Pacific Medical Center Research Institute |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04364230 -
Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)
|
Phase 1/Phase 2 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT05542342 -
Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.
|
Phase 2 | |
Completed |
NCT02849145 -
Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
|
N/A | |
Recruiting |
NCT01438658 -
Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma
|
N/A | |
Not yet recruiting |
NCT00811200 -
Treatment Of Radiation Retinopathy Trial
|
Phase 2/Phase 3 | |
Completed |
NCT00121225 -
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
|
Phase 2 | |
Completed |
NCT03297424 -
A Study of PLX2853 in Advanced Malignancies.
|
Phase 1 | |
Withdrawn |
NCT05482074 -
Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2
|
Phase 2 | |
Completed |
NCT04551352 -
A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas
|
Phase 1 | |
Not yet recruiting |
NCT06246149 -
Adjuvant Tebentafusp in High Risk Ocular Melanoma
|
Phase 3 | |
Completed |
NCT01955941 -
Vascular Response to Brachytherapy Using Functional OCT
|
||
Completed |
NCT00661622 -
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
|
Phase 2 | |
Recruiting |
NCT05502900 -
Adjuvant Melatonin for Uveal Melanoma
|
Phase 3 | |
Active, not recruiting |
NCT03070392 -
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
|
Phase 2 | |
Recruiting |
NCT06284512 -
Uveal Melanoma - Comparative Study
|
||
Recruiting |
NCT05524935 -
Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT02913417 -
Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06073548 -
Patient Experience and Quality of Life During the Surveillance Phase of Uveal Melanoma: A Prospective Multi-method Study
|
||
Recruiting |
NCT06075589 -
Psychoeducation for Uveal Melanoma
|