Actively Recruiting
CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition
Led by Mark Stein · Updated on 2025-04-25
48
Participants Needed
4
Research Sites
397 weeks
Total Duration
On this page
Sponsors
M
Mark Stein
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and authorization for release of personal health information
- Be 18 years of age or older at the time of consent
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days before registration
- Have radiographic or histological evidence of metastatic renal cell carcinoma with a clear cell component
- Have measurable tumor in the kidney according to RECIST 1.1 criteria
- Have not received prior therapy for metastatic renal cell carcinoma
- Demonstrate adequate organ function as defined in the study protocol with labs obtained within 14 days before registration
- Females of childbearing potential must have a negative pregnancy test within 14 days before treatment
- Females of childbearing potential and males must agree to use two forms of effective contraception or abstain from heterosexual activity from consent until 6 months after treatment ends
- Be able to understand and comply with study procedures for the entire study duration as determined by the physician
You will not qualify if you...
- Have had prior nephrectomy for renal cancer
- Have uncontrolled bleeding, high blood pressure, or cardiovascular disease
- Have been treated previously with PD-1/PD-L1 or anti-CTLA-4 therapies
- Have active brain metastases or epidural disease
- Have received radiation therapy for bone metastases within 2 weeks or other radiation within 4 weeks before first treatment dose
- Have abnormal blood clotting tests exceeding 1.3 times the upper normal limit
- Require therapeutic doses of anticoagulants like warfarin, thrombin, or Factor Xa inhibitors (aspirin and low-dose warfarin allowed)
- Have had significant gastrointestinal bleeding within 6 months before treatment
- Have coughed up blood (hemoptysis) of 0.5 teaspoon or more within 3 months before treatment
- Have cavitating lung lesions or known airway tumors
- Have tumor invading the gastrointestinal tract or airway within 28 days before treatment
- Have active or history of autoimmune disease affecting vital organs or requiring immunosuppressive treatment
- Require systemic corticosteroids above 10 mg prednisone equivalents or other immunosuppressants within 14 days before study
- Have severe heart failure or uncontrolled hypertension
- Have a corrected QT interval over 500 ms within 28 days before registration
- Have active severe infection requiring systemic treatment within 28 days before treatment
- Have serious non-healing wounds, ulcers, or bone fractures within 28 days before treatment
- Have had major surgery within 8 weeks before treatment and not fully healed
- Have history of organ transplant
- Have uncontrolled hypothyroidism
- Be unable to swallow tablets
- Have active infection requiring systemic therapy
- Be pregnant or breastfeeding
- Have another active or progressive cancer requiring treatment except certain skin, cervical, bladder, or treated cancers disease-free for 2 years
- Have active central nervous system metastases
- Have received investigational drugs within 28 days before registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
The Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44012
Actively Recruiting
4
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43221
Actively Recruiting
Research Team
R
Research Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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