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ASCO 2025 | Phase II trial of sarilumab and checkpoint inhibition in stage III/IV melanoma

Janice Mehnert, MD, Perlmutter Cancer Center of NYU Langone Health, New York, NY, discusses a Phase II trial (NCT05428007) evaluating sarilumab with nivolumab, relatlimab, and ipilimumab in patients with unresectable stage III/IV melanoma. The regimen showed promising antitumor activity alongside a reduced rate of high-grade immune-related adverse events compared to historical data. These findings support further exploration of interleukin-6 receptor inhibition to improve the safety of checkpoint inhibitor-based therapies. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

I am going to be on Monday presenting part one of our trial, which looks at the first 33 patients that we treated with a quadruplet regimen of ipilimumab, nivolumab, relatlimab, and sarilumab . And what we found is a response rate that was 63, almost 64%, which is among the higher responses we’ve seen in combination regimens that include CTLA-4 blockade with ipilimumab...

I am going to be on Monday presenting part one of our trial, which looks at the first 33 patients that we treated with a quadruplet regimen of ipilimumab, nivolumab, relatlimab, and sarilumab . And what we found is a response rate that was 63, almost 64%, which is among the higher responses we’ve seen in combination regimens that include CTLA-4 blockade with ipilimumab. And we found a toxicity rate, a grade 3-4 toxicity rate that we measured at 24 weeks, which was the amount of time that we gave all four of these drugs. And that toxicity rate was 12%, which is definitely improved from what we’ve seen in prior trials where we combined ipilimumab, nivolumab, relatlimab, or even just ipilimumab and nivolumab together. So we’re excited because we are seeing that signal of potentially even improved response and definitely decreased toxicity. And what we’re going to do now is going on to part two of the trial where we’re actually going to have a randomized portion of 30 patients per arm of the quadruplet regimen versus the regimen without the sarilumab to see if there’s truly a definite effect there.

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