Cyto-KIK; TRIAL (CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy (Nivolumab) and Targeted Kinase Inhibition (Cabozantinib)

Who is this study for? Patients with kidney cancer
What treatments are being studied? Cabozantinib+Nivolumab+Cytoreductive nephrectomy
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent and HIPAA authorization for release of personal health information.

• Age ≥ 18years at the time of consent.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 28 days prior to registration.

• Radiographically consistent with metastatic renal cell carcinoma (with subsequent pathologic confirmation of renal cell carcinoma with a clear cell component) OR histological/ cytological evidence of metastatic renal cell carcinoma with a clear cell component

• Measurable tumor in the kidney according to RECIST 1.1

• No prior therapy for metastatic renal cell carcinoma

• Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 14 days prior to registration.

• Females of childbearing potential must have a negative serum pregnancy test during screening, within 14 days of Cycle 1 Day 1. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months

• Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.

⁃ As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

Locations
United States
New Jersey
The Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Columbia University Irving Medical Center
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Ohio State University Wexner Medical Center
RECRUITING
Columbus
Contact Information
Primary
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162
Time Frame
Start Date: 2020-06-22
Estimated Completion Date: 2028-02
Participants
Target number of participants: 48
Treatments
Experimental: Treatment with cabozantinib and nivolumab with nephrectomy
All study participants will receive the same study medications, cabozantinib and nivolumab. The study drug, nivolumab, will be administered through an IV infusion every 4 weeks and cabozantinib will be administered orally daily. Initially participants will receive study treatment for 12 weeks. The cabozantinib will then be stopped prior to the nephrectomy. Initially patients enrolled on the study will be assigned to cohort 1.~Patients who are assigned to cohort 1 will be treated with cabozantinib until 21 days prior to surgery. A patient in cohort 1 will be evaluable for assessment of the cabozantinib washout interval (evaluable patients) if they~1. complete at least 10 of the 14 scheduled cabozantinib doses in the two week period prior to stopping cabozantinib AND~2. have surgical resection of the primary tumor.~In cohort 2, subjects will receive cabozantinib until 14 days prior to nephrectomy.
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb, Exelixis
Leads: Mark Stein

This content was sourced from clinicaltrials.gov