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Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma: OMNIVORE Trial

By: Vanessa A. Carter, BS
Posted: Friday, January 1, 2021

Immune checkpoint inhibitors have greatly reformed the treatment landscape for patients with advanced renal cell carcinoma. Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, Boston, and colleagues conducted the phase II OMNIVORE study to determine the efficacy of the immunotherapy combination of nivolumab and ipilimumab in patients with metastatic renal cell cancer. Their findings, which were published in the Journal of Clinical Oncology, reported no complete responses.

In addition, “nivolumab followed by two doses of ipilimumab resulted in…a low partial response/complete response conversion,” the study authors concluded. “Currently, our data do not support a response-adaptive strategy for checkpoint blockade in advanced renal cell carcinoma.”

In this phase II study, 83 patients with metastatic renal cell carcinoma who had no prior checkpoint inhibitor exposure were enrolled. All patients were administered nivolumab alone, and they were placed in respective arms based on their response. Arm A contained individuals with a confirmed partial or complete response after 6 months of completing treatment. Participants with stable or progressive disease after 6 months of completing treatment received two doses of ipilimumab and were placed into arm B.

Of the patients, 95% had clear cell histology, 67% had intermediate- or poor-risk disease, and 51% never received prior treatment. Induction nivolumab produced a confirmed partial response in 12% of participants within 6 months. A total of 14 patients could not be assigned to a study arm due to either toxicity or progressive disease. Arm A contained 12 patients who discontinued nivolumab, 5 of whom stayed off treatment for at least a year. Confirmed partial response occurred in 2 of the 57 patients in arm B, and no complete responses were observed.

“The number of patients evaluated for nivolumab discontinuation was too small to assess the value of this approach,” commented the investigators.

Disclosure: For full disclosures of the study authors, visit ascopubs.org.



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