NCT03149159

Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab

An Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab

• Status: Withdrawn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

Summary

The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.

Conditions

• Clear Cell Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab will be given every 21 days for the first 12 weeks at a dose of 3mg/kg. After 12 weeks, the dose will be 240mg and will be given every 14 days.
DRUG	Ipilimumab	Ipilimumab will be given at a dose of 1mg/kg every 21 days for up to 12 weeks.
RADIATION	Steriotactic radiation therapy	The dose of radiation will be 6 Gy daily x 5 days. Radiation will be given between the first and second doses of ipilimumab plus nivolumab.

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2017-05-11
• Last updated: 2018-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study