Phase II trial of pembrolizumab, ipilimumab, and aspirin in melanoma: clinical outcomes and translational predictors of response.

ABSTRACT:

Objective

Many patients with melanoma treated with immune checkpoint inhibitors (ICIs) do not derive response. Preclinical and retrospective studies identified that inhibition of the cyclooxygenase (COX) pathway may improve response to ICI treatment.

Methods

This prospective single site phase II trial accrued patients with advanced/metastatic melanoma. Participants underwent high-dose aspirin daily combined with pembrolizumab and ipilimumab every 3 weeks for 4 cycles followed by high-dose aspirin and pembrolizumab monotherapy. The primary endpoint was objective response rate (ORR). Longitudinal sampling of blood was performed to assess peripheral immune correlates.

Results

Twenty-seven subjects were enrolled with median follow-up of 32 months. An ORR of 62.9% was reac

SUBMITTER: Quandt Z 

PROVIDER: S-EPMC11524064 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature