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
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|ClinicalTrials.gov Identifier: NCT03149159|
Recruitment Status : Withdrawn (This study is withdrawn due to feasibility issues.)
First Posted : May 11, 2017
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Metastatic Renal Cell Carcinoma||Drug: Nivolumab Drug: Ipilimumab Radiation: Steriotactic radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 With Single-Agent Nivolumab|
|Actual Study Start Date :||April 1, 2018|
|Actual Primary Completion Date :||April 1, 2018|
|Actual Study Completion Date :||April 1, 2018|
|Experimental: Nivolumab + Ipilimumab + SRT||
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.
Other Name: opdivo
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.
- 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.
- Progression free survival (PFS) [ Time Frame: 2 years ]PFS will be determined from the onset of treatment to the time of documented disease progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149159
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Michael Lilly, MD||Medical University of South Carolina|