Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer

July 07, 2021
PDIGREE (A031704)
Renal Cancer
Brian Myre, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

 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.

Sponsor: Alliance for Clinical Trials in Oncology

  • Renal cell carcinoma with clear cell component, including patients who have sarcomatoid features.
  • Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment. 
  • No prior treatment with nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, ipilimumab, or certain other drugs or antibodies
  • No active autoimmune disease requiring ongoing therapy.
  • No concurrent use of immunosuppressive medication including prednisone above 10 mg daily.
  • No uncontrolled adrenal insufficiency or uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP > 90 mmHg)
  • No unstable cardiac arrhythmia within 6 months prior to registration.
  • No gastrointestinal (GI) bleeding =< 180 days, hemoptysis, or other signs of pulmonary hemorrhage =< 90 days prior to registration.
  • No history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration.
  • No active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome within 28 days prior to registration.
  • No untreated hypothyroidism, evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome
  • No significant cardiac ischemia events within 6 months or class 3-4 heart failure symptoms
Up to 5 years
Accepting Participants
Jessica Schnase, Mgr Cancer Research