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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03680521|
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma||Drug: Sitravatinib Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 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|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||April 2020|
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
|Contact: Mirati Therapeuticsemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jose A Karam, MD 713-792-3250 firstname.lastname@example.org|