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

PHASE1CompletedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

August 9, 2022

Primary Completion Date

June 13, 2023

Study Completion Date

July 17, 2024

Conditions
Melanoma, OcularMelanoma, CutaneousMetastatic MelanomaMelanoma, MucosalLiver Metastases
Interventions
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

Trial Locations (1)

48109

University of Michigan Rogel Cancer Center, Ann Arbor

All Listed Sponsors
lead

University of Michigan Rogel Cancer Center

OTHER