Nivolumab plus ipilimumab (nivo/ipi) demonstrated promising antitumor efficacy in patients with advanced renal cell carcinoma (RCC) that had previously progressed with immune checkpoint inhibitor (ICI) therapy, according to results from the phase 2 FRACTION-RCC trial presented at the ASCO20 Virtual Scientific Program.

“FRACTION-RCC is an innovative, signal-seeking phase 2 trial with a rolling, adaptive platform design that allows for the rapid evaluation of I-O [immuno-oncology] combinations in patients with advanced RCC,” explained Tony K. Choueiri, MD, of the Dana-Farber Cancer Institute in Boston, and lead author and presenter of the study.

Although nivolumab plus ipilimumab is approved for first-line therapy in advanced RCC, “the role of immunotherapy following progression on first-line checkpoint inhibitor treatments has not yet been established,” Dr Choueiri said.

This analysis was of the cohort that included 46 patients with advanced RCC who had progressed on a previous ICI, except 1 patient who received 1 dose of ICI therapy prior to beginning the study but after enrollment. A second cohort included patients who were ICI treatment–naïve, and was not included in this analysis. Patients received nivolumab plus ipilimumab for up to 2 years. The primary endpoints included objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS) at 24 weeks.

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At baseline, the median age of patients was 61 and 80% were male. All patients received a prior anti–PD-1/PD-L1 antibody and 80% had received a prior tyrosine kinase inhibitor–based regimen. None of the patients had previously received an anti–CTLA-4 antibody.

The ORR was 15.2% (95% CI, 6.3%-28.9%) and the disease control rate was 52.2% (95% CI, 36.9%-67.1%) during a median follow-up of 21.6 months. The DOR was not yet mature.

The median PFS was 16.1 weeks (95% CI, 9.4-31.9 months).

Twenty-eight percent of patients developed grade 3-4 treatment-related adverse events (TRAEs); diarrhea or elevated amylase or lipase were the most commonly reported TRAEs. Immune-related TRAEs of any grade occurred in 47.8% of patients; the most common were rash, diarrhea, and elevated alanine aminotransferase levels. TRAEs resulted in 7% of patients discontinuing treatment.

Dr Choueiri said that “while the efficacy of nivo/ipi after checkpoint inhibitor-based therapy observed here was not as robust as seen in treatment-naive patients in the CheckMate 214 trial, these results help inform a data gap concerning the use of nivo/ipi after previous I-O treatment.”

Disclosure: Research funding for this study was provided by Bristol-Myers Squibb. For a complete list of author disclosures please refer to the reference.


Choueiri TK, Kluger HM, George S, et al. FRACTION-RCC: Innovative, high-throughput assessment of nivolumab + ipilimumab for treatment-refractory advanced renal cell carcinoma (aRCC). Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 5007.  

This article originally appeared on Cancer Therapy Advisor