Study ID: PDIGREE
Immunotherapy with nivolumab and ipilimumab followed by nivolumab or nivolumab with cabozantinib for patients with advanced kidney cancer
This phase III clinical trial is for patients with untreated kidney cancer that has spread to other parts of the body. It is comparing the usual treatment—which is Yervoy® (ipilimumab) and Opdivo® (nivolumab) followed by nivolumab alone—to treatment with ipilimumab and nivolumab, followed by nivolumab with Cabometyx® (cabozantinib). Researchers seek to determine if the addition of cabozantinib to the usual treatment is better at treating cancer than the usual treatment without it.
Nivolumab and ipilimumab are types of medications called monoclonal antibodies and are commonly referred to as immunotherapies. These types of drugs help the body’s immune system attack the cancer and may prevent the cancer cells from growing and spreading.
Cabozantinib is a chemotherapy medication and works differently from immunotherapies but can also prevent cancer from growing and spreading.
It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with kidney cancer that has spread to other parts of the body.
All patients in this study receive nivolumab IV over 30 or 60 minutes and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to four cycles.
- Patients with PD receive cabozantinib PO daily on days 1–28.
- Those with CR receive nivolumab IV over 30 or 60 minutes on day 1; treatment repeats every 28 days.
- Patients with non-CR/non-PD receive nivolumab IV over 30 or 60 minutes on day 1, and one group (the experimental arm) also receives cabozantinib PO daily on days 1–28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- Must have histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features
- Must have metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1
- No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents, or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways
- Must have no active autoimmune disease requiring ongoing therapy
Other inclusion criteria apply.