Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Medical University of South Carolina

Current Primary Outcome: Number of patients with a partial or complete response [ Time Frame: 12 weeks ]

The response rate of combined ipilimumab and nivolumab plus STR will be determined using irRECIST criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome: Progression free survival (PFS) [ Time Frame: 2 years ]

PFS will be determined from the onset of treatment to the time of documented disease progression.


Original Secondary Outcome: Same as current

Information By: Medical University of South Carolina

Dates:
Date Received: May 4, 2017
Date Started: July 1, 2017
Date Completion: December 1, 2020
Last Updated: May 9, 2017
Last Verified: March 2017