Non-clear cell renal cell carcinoma (nccRCC) accounts for only 3-4% of all adult cancers, and that rarity has long hampered investigators’ ability to recruit significant numbers of patients for clinical trials. The path to more effective therapies has faced other challenges as well: nccRCC encompasses several types of tumors with varying histologic characteristics and molecular drivers, making it difficult to identify a treatment that will be equally effective across the board.
As a result, patients with this aggressive cancer face a poor prognosis, few treatment options and no established standard of care. That’s why the National Comprehensive Cancer Network recommends clinical trials as the preferred treatment.
In the search for a new and more effective treatment strategy, a phase 3 clinical trial is underway at Roswell Park Comprehensive Cancer Center. It will evaluate the potential of combining an investigational drug, the targeted therapy XL092 (brand name Zanzalintinib), with the FDA-approved immunotherapy nivolumab (brand name Opdivo).
Saby George, MD, FACP, Professor of Oncology in the Department of Medicine and Director of Network Clinical Trials at Roswell Park, serves as site Principal Investigator of “Study of XL092 + Nivolumab vs. Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (STELLAR-304” (NCT05678673). Sponsored by Exelixis, this randomized (2:1), open-label study is open to patients with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic therapy.
Patients in one group will receive sunitinib (brand name Sutent), a tyrosine kinase inhibitor that is FDA-approved for localized kidney cancer and currently the mainstay treatment. The second group will receive the investigational combination. XL092, a tyrosine kinase inhibitor, was designed to target multiple types of advanced tumors and in previous clinical trials has shown promising activity against advanced nccRCC. Nivolumab, an immune checkpoint inhibitor, is FDA-approved for advanced renal cell carcinoma.
The study is available at only 11 locations in the United States.
BROADCASTMED