A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk (Protocol number: XL184-313)
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
To assess whether the investigational combination of cabozantinib, nivolumab, and ipilimumab compared with nivolumab and ipilimumab alone is safe and effective in slowing down the growth of renal cell carcinoma (RCC). Nivolumab and ipilimumab are FDA Approved for the treatment of RCC. Cabozantinib alone is FDA approved for treatment of RCC. The combination of the three drugs are considered experimental. This is a double-blind study; you or your doctor/study team will not know which medication -cabozantinib or placebo - received in combination with nivolumab and ipilimumab until the study is completed or earlier, as determined by the Sponsor. In case of an emergency, where knowledge of the medication is necessary for emergency medical care, your study doctor can find out whether you were taking cabozantinib, and you will be discontinued from the study.
Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma with a clear-cell component, including subjects who also have a sarcomatoid feature.Intermediate- or poor-risk RCC Biopsy (if archived tumor tissue is greater than 2 years old)Screening Evaluation results meet the study parametersNo Prior PD-1 or PDL-1 therapyPrednisone or Prednisone Equivalent total is less than 10 mg in 24 hoursNo Anti-coagulation products (exception Aspirin 81 mg or low dose low molecular Heparin)Controlled Hypertension (Blood Pressure has to be lower than 150/90)No Active Infection or Auto-immune DisordersNo other Cancers within 3 years (exception: basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)Bone Scan Required at screening
The first four doses of nivolumab IV will be administered once every 3 weeks followed by ipilimumab Then nivolumab IV will be administered every 4 weeks. In this study, treatment with nivolumab will be given for a maximum of 2 years from the start of studytreatment.Oral study medication will be once daily. Must fasted (with the exception of water) for at least 2 hours before taking the oral study medication. Must take the study medication with a minimum of 8 oz of water and then continue to fast for 1 hour after taking the study medication
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