The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney, will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment.
People with metastatic kidney cancer are usually treated with medications to slow the growth of the cancer. In addition, people who still have the kidney where the cancer started may have the kidney removed during the course of treatment. This surgery is done in order to decrease the amount of tumor in the body. This surgery is referred to as a cytoreductive nephrectomy. In the current study, nivolumab, an immune checkpoint inhibitor, is being administered in combination with cabozantinib, a targeted therapy. The combination of nivolumab and cabozantinib is FDA approved for the treatment of metastatic kidney cancer. In this study, treatment consists of cabozantinib and nivolumab plus a cytoreductive nephrectomy. Eligible subjects, who have not received prior therapy for metastatic clear cell renal cell carcinoma, are treated with cabozantinib and nivolumab for approximately 3 months prior to undergoing cytoreductive nephrectomy. After nephrectomy, patients who are benefiting from treatment may resume cabozantinib and nivolumab. This study will help investigators to understand the immune effects of cabozantinib and nivoluamb in the kidney tumor and will provide information on the potential clinical benefit associated with cytoreductive nephrectomy in combination with cabozanitnib and nivolumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
2 x 20 mg capsules taken orally daily
480mg IV on first day of each 28-day cycle
Surgery removing as much tumor tissue as possible, possibly including surrounding tissues.
The Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGColumbia University Irving Medical Center
New York, New York, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGPercentage of Participants with a Complete Response
The percentage of participants with a complete response following treatment. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Time frame: Up to 5 years after completion of treatment
Median Size Reduction of the Primary Tumor
Median size reduction of the primary tumor after treatment for 12 weeks prior to nephrectomy will be determined using RECIST 1.1 criteria applied to the primary tumor.
Time frame: 12 weeks
Progression Free Survival (PFS)
PFS is defined as the time from the time of first treatment on study until disease's progression or death as a result of any cause.
Time frame: Up to 5 years after completion of treatment
Response Rate
Response rate will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST1.1.
Time frame: Up to 5 years after completion of treatment
Overall Survival
Overall survival will be measured from the time of first treatment on study until death or last follow-up.
Time frame: Up to 5 years after completion of treatment
Surgical Outcomes
Surgical outcomes will be assessed by the Clavien-Dindo classification system, which ranks the severity of surgical complications. The scale consists of several grades (Grade I, II, IIIa, IIIb, IVa, IVb and V) from Grade I being of low severity outcome to Grade V being highest and worst outcome.
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Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGTime frame: Up to 5 years after completion of treatment