Clinical Trial TitleA randomized, double-blind, controlled phase 3 study of cabozantinib in combination with nivolumab and ipilimumab vs nivolumab and ipilimumab in subjects with previously untreated advanced or metastatic renal cell carcinoma of intermediate or poor risk.
Clinical Trial Protocol Description:
This is a clinical research study for kidney cancer (renal cell carcinoma or RCC) that has advanced or spread to other areas of your body. If you join this study, you will receive cabozantinib (XL184) in combination with nivolumab plus ipilimumab, or placebo in combination with nivolumab plus ipilimumab.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
- Have intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria.
- Have measurable disease per RECIST 1.1 as determined by the Investigator.
- Have a Karnofsky Performance Status (KPS) ≥ 70%.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior systemic therapy for unresectable locally advanced or metastatic RCC including investigational agents.
- Have uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesion invading major pulmonary blood vessels.
- Have had major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Prior laparoscopic nephrectomy within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from major surgery or minor surgery before randomization.
- Have any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
This is a partial list of inclusion and exclusion criteria.