NCT05169957

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma, Ocular
• Melanoma, Cutaneous
• Metastatic Melanoma
• Melanoma, Mucosal
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab administered IV over 85-100 minutes at 3 mg/kg (combined with nivolumab administered IV over 30-60 minutes at 1 mg/kg) every 3 weeks for a total of 4 doses or until progression or unacceptable toxicity.
DRUG	Nivolumab	Nivolumab administered IV over 30-60 minutes at 1 mg/kg (combined with ipilimumab administered IV over 85-100 minutes at 3 mg/kg) every 3 weeks for a total of 4 doses of the combination therapy or until progression or unacceptable toxicity. Subjects may receive maintenance dosing of nivolumab alone administered IV over 30-60 minutes at 240 mg every 2 weeks or 480 mg every 4 weeks for a maximum of 52 weeks or until progression or unacceptable toxicity.
PROCEDURE	Stereotactic Body Radiation Therapy	24-45 Gy delivered in three fractions to up to 4 liver metastases

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-06-13
• Completion: 2024-07-17
• First posted: 2021-12-27
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study