Clinical Trial of the Week: New treatment trial for patients with advanced kidney cancer

By Donna Loyle, communications specialist, LIMR 

PDIGREE is new phase III clinical trial for patients with untreated metastatic kidney cancer. Researchers seek to determine if the addition of cabozantinib to the usual treatment — which is ipilimumab and nivolumab followed by nivolumab alone — is better at treating cancer than the usual treatment without it.

Inclusion criteria:

  • 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.

 All patients in this study receive nivolumab IV and ipilimumab IV on day 1. Treatment repeats every 21 days for up to 4 cycles.

  • Patients with PD receive cabozantinib PO daily on days 1-28.
  • Those with CR receive nivolumab IV on day 1; treatment repeats every 28 days.
  • Patients with non-CR/non-PD receive nivolumab IV 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.

This study is approved for all Main Line Health acute care hospitals. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more, email cancertrials@mlhs.org or visit www.mainlinehealth.org/research/clinical-trials/pdigree

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