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
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
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.
safety and tolerability of the therapy
stereotactic body radiotherapy
Study Arms / Comparison Groups
Description: see below
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
September 20, 2021
Primary Completion Date
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
18 Years - N/A
Accepts Healthy Volunteers
David R Minor, MD, 4156006000, [email protected]
California Pacific Medical Center Research Institute
David R Minor, MD, Study Chair, California Pacific Med Center Research Inst.