Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03680521|
Recruitment Status : Active, not recruiting
First Posted : September 21, 2018
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma||Drug: Sitravatinib Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients Undergoing Nephrectomy for Locally-Advanced Clear Cell Renal Cell Carcinoma|
|Actual Study Start Date :||September 24, 2018|
|Actual Primary Completion Date :||April 27, 2020|
|Estimated Study Completion Date :||April 27, 2025|
Experimental: Sitravatinib and nivolumab
Sitravatinib oral capsule administered daily 2 weeks alone then in combination with nivolumab administered as 240 mg IV every 2 weeks. Total treatment duration: 6-8 weeks.
Sitravatinib oral capsule administered daily for 6-8 weeks.
Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks.
- Percentage of patients achieving a point in time objective response (either complete or partial response [CR or PR]) prior to surgery. [ Time Frame: 6-8 weeks ]
- Number of patients experiencing adverse events (number and percent of patients reporting AEs) [ Time Frame: 12 weeks ]
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): NCT03680521
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|