NCT03126461

SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients

Phase 2 Trial of SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients

Detailed description

SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity

Conditions

• Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
RADIATION	SAbR	For patients treated on the "GRID A" regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions). For patients treated on the "GRID B" regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose.
DRUG	Ipilimumab	ipilimumab 3mg/kg IV q3wk x 4
DRUG	Nivolumab	nivolumab 1 mg/kg IV q3wk x 4

Timeline

• Start date: 2018-03-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-04-24
• Last updated: 2020-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study