Study Name: A031704

Recruiting

Renal

PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]

NCT#NCT03793166

clinicaltrials.gov/show/NCTNCT03793166

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. 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. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 renal cell cancer that has spread to other parts of the body.

Male and Female – 18 years and older

• Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features. Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.

• Active autoimmune disease requiring ongoing therapy. Ongoing acute toxicity > grade 2 from previous treatment. History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies.