drugset
drugset / Trial / NCT05169957

Hepatic Ablation of Melanoma Metastases to Enhance Immunotherapy Response, a Phase I Clinical Trial (HAMMER I)

NCT05169957 ↗

Phase 1 Completed 2 enrolled University of Michigan Rogel Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (ipilimumab and nivolumab) in adults with metastatic melanoma with liver metastases who are at significant risk of not benefiting from systemic therapy alone.

Timeline

Start
2022-08-09
Primary completion
2023-06-13
Completion
2024-07-17

Drugs

EvaluationDrugModalityDoseRoute
Background Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Background Nivolumab Monoclonal antibody 1 mg/kg Intravenous
Background Nivolumab Monoclonal antibody 240 mg Intravenous
Background Nivolumab Monoclonal antibody 480 mg Intravenous

Indications

cutaneous melanoma metastatic melanoma mucosal melanoma ocular melanoma