Salvage Nivolumab Plus Ipilimumab After Prior Immune Checkpoint Inhibitor Therapy in Patients With Metastatic Renal Cell Carcinoma

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In a study reported in the Journal of Clinical Oncology,1 Anita Gul, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues found that salvage therapy with nivolumab/ipilimumab was capable of producing a response after prior PD-1 pathway inhibitor therapy in some patients with metastatic renal cell carcinoma.

Study Details

The retrospective analysis included 45 patients from five U.S. centers who had not received prior anti–CTLA-4 antibody treatment. Overall, 76% had received an anti–PD-1 antibody, and 24% received an anti–PD-L1 antibody either alone or in combination with other therapies. Best overall response on anti–PD-1 therapy was partial response in 53% of patients, stable disease in 27%, and progressive disease in 20%.

Key Findings

Median follow-up was 12 months. Among 44 evaluable patients receiving salvage nivolumab/ipilimumab, a partial response was observed in 9 (20%), stable disease in 7 (16%), and progressive disease in 28 (62%). 

Among 24 patients with a partial response to prior therapy, a partial response was observed in 4, stable disease in 2, and progressive disease in 17 with salvage therapy. Among 12 patients with stable disease on prior therapy, 3 had a partial response, 5 had stable disease, and 4 had progressive disease. Among nine patients with progressive disease on prior therapy, two had a partial response and seven had progressive disease.

The median duration of response was 7 months (range = 2–17 months), and median progression-free survival was 4 months (range = 0.8–19 months). Among nine patients with a partial response, six had an ongoing response, and five were receiving maintenance nivolumab at the time of analysis.

Immune-related adverse events of any grade were observed in 64% of patients, with the most common being diarrhea (16%), rash (13%), hepatotoxicity (9%), and pneumonitis (7%). Grade 3 or 4 immune-related adverse events were observed in 13%, with the most common being hepatotoxicity (7%) as well as pneumonitis, rash, diarrhea, thrombocytopenia, and colitis (2% each). No treatment-related deaths were reported.

The investigators concluded: “Ipilimumab and nivolumab demonstrated antitumor activity with acceptable toxicity in patients with metastatic renal cell carcinoma who had prior treatment with checkpoint inhibition.”

Disclosure: Dr. Gul has served on a speakers bureau for Dava Oncology.


1. Gul A, Stewart TF, Mantia CM, et al: Salvage ipilimumab and nivolumab in patients with metastatic renal cell carcinoma after prior immune checkpoint inhibitors. J Clin Oncol. June 3, 2020 (early release online).