The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

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.

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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.

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).

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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.

Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.


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.