MIAMI – Patients with metastatic clear cell renal cell carcinoma (mccRCC) who experience RECIST-defined disease progression may be able to safely continue nivolumab treatment and have similar survival to those who discontinued treatment, a study presented at the 14th International Kidney Cancer Symposium 2015 (IKCS 2015) has shown.1

“As with other immunotherapies, in some patients, nivolumab has been associated with tumor flare before tumor reduction,” Saby George MD, FACP, of the Roswell Park Cancer Institute in Buffalo, NY, said during the poster presentation. “In patients on immunotherapy, tumor flare or the appearance of new lesions may precede antitumor effects.”

Therefore, researchers sought to evaluate the efficacy and safety of a subset of patients who received nivolumab treatment beyond RECIST-defined disease progression in order to determine the potential benefits of this treatment strategy.

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For the study, researchers analyzed data from 36 patients with mccRCC who were randomly assigned to receive varying doses of nivolumab intravenously every 3 weeks until disease progression or unacceptable toxicity and were treated beyond progression.

Results showed that median duration of therapy from first progression to last dose or death was 4.2 months (95% CI, 1.5 – 32.2) for patients who discontinued treatment, 13.8 months (95% CI, 1.7 – 32.9) for patients who discontinued treatment and died, and 37.4 months (95% CI, 33.2 – 37.8) for patients still on treatment.

Researchers found that median progression-free survival from randomization to first progression was 4.2 months (95% CI, 2.8 – 5.5) while median overall survival was 30.6 months (95% CI, 18.2 – 41.2).

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In regard to safety, 81% of patients experienced nivolumab-related adverse events. Grade 3 to 4 fatigue, deep vein thrombosis, and embolism each occurred in 1 patient.

“Further analysis of randomized phase 3 trials will help validate the clinical benefit for patients with mRCC treated with nivolumab beyond progression,” Dr. George concluded.


  1. George S, Motzer RJ, Hammers H, et al. Efficacy and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC) who were treated beyond progression in a randomized phase 2 dose-ranging trial [abstract]. BJU Int. 2015. doi: 10.1111/bju.13365.