Adding ipilimumab to treatment with nivolumab does not provide a clinically meaningful benefit in patients with certain cancers, according to a meta-analysis published in JAMA Oncology.

The meta-analysis included data from 8 studies that enrolled patients with several cancers — esophagogastric carcinoma, glioblastoma multiforme, non-small cell lung cancer with a PD-L1 level of 1% or higher, pleural mesothelioma, sarcoma, small cell lung cancer, squamous cell lung cancer, and urothelial carcinoma.

In a pooled analysis, the overall survival was similar between patients who received ipilimumab plus nivolumab and those who received nivolumab alone (hazard ratio [HR], 0.95; 95% CI, 0.85-1.06; P =.36). In fact, in 4 studies, the median overall survival was numerically lower with ipilimumab plus nivolumab.

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Overall, progression-free survival was significantly longer with nivolumab plus ipilimumab than with nivolumab alone (HR, 0.88; 95% CI, 0.79-0.98; P =.02), but this difference was not considered clinically meaningful.

The researchers noted that there was only 1 study in which nivolumab plus ipilimumab provided a significant benefit in progression-free survival (HR, 0.84; 95% CI, 0.72-0.99). It was the largest study evaluated and accounted for more than 40% of the weight in the meta-analysis.

The researchers also found that the risk of grade 3-4 adverse events was significantly higher with nivolumab plus ipilimumab than with nivolumab alone (odds ratio [OR], 1.84; 95% CI, 1.47-2.31; P <.001).

Treatment-related discontinuations were more likely among patients who received nivolumab plus ipilimumab than among patients who received nivolumab alone as well (OR, 1.96; 95% CI, 1.45-2.66; P <.001).

“[T]he addition of ipilimumab to standard-dose nivolumab was not associated with a clinically meaningful improvement in overall survival or progression-free survival over standard-dose nivolumab alone,” the researchers wrote. “The combination was associated with substantially higher treatment-related high-grade toxicities without commensurate clinical benefit.”


Serritella AV, Shenoy N. Nivolumab plus ipilimumab vs nivolumab alone in advanced cancers other than melanoma. A meta-analysis. JAMA Oncol. Published online August 31, 2023. doi:10.1001/jamaoncol.2023.3295