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# FDA Partial Hold on Alpine Immune Cancer Trial
- URL: https://www.fdaweb.com/fda-partial-hold-on-alpine-immune-cancer-trial/
- Published: 2022-03-07T12:00:00.000Z
- Updated: 2026-09-14T17:35:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151303

FDA has placed a partial clinical hold on Alpine Immune Sciences’ NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab (Merck’s Keytruda) in adults with advanced malignancies. The regulatory hold was the result of Alpine’s report of a Grade 5 serious adverse event (patient death) in the trial. “The participant had choroidal melanoma previously treated with nivolumab and ipilimumab, and had received a single dose each of davoceticept and pembrolizumab,” the company says. “The participant’s death was attributed to cardiogenic shock, considered by the treating physicians as likely related to immune-mediated myocarditis, or possibly infection.”

“We appreciate the dialogue with FDA and look forward to working diligently with FDA, Merck, the study safety monitoring committee, and the study investigators to further understand this unfortunate event,” Alpine says. “Patients currently enrolled in the NEON-2 trial may continue to receive davoceticept and pembrolizumab, although no additional patients may be enrolled until the partial clinical hold is resolved.” The hold does not apply to the ongoing NEON-1 clinical trial of davoceticept as monotherapy.

Davoceticept is described as a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor for treating cancer. The company says preclinical studies have demonstrated “superior efficacy” in tumor models compared to checkpoint inhibition alone.