Status:
Recruiting
Disease Site:
Metastatic
Diagnosis:
- Renal Cell Carcinoma
Phase:
Official Title:
PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer
NCT ID:
NCT#03793166
Link to Full Details:
Investigators:
- Dr. Mark Olsen
Description:
This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Histologically documented RCC with clear cell component including sarcomatoid features
- No prior treatment
- Any MEASURABLE metastatic disease
Exclusion Criteria:
- Active autoimmune disease
- History of HIV, active hep b/C, or tuberculosis
- Active treatment with warfarin or any oral factor Xa inhibitors