Pembrolizumab Phase 3 Trial Reaches Primary Completion in Melanoma

ClinicalTrials.gov recorded primary completion on 2024-03-06 for a phase 3 trial of pembrolizumab in resected high-risk melanoma. The terminated study enrolled 1,594 participants and compared adjuvant pembrolizumab/vibostolimab with pembrolizumab alone, using recurrence-free survival as its primary focus. The posted hazard ratio was 1.25, with a 95% confidence interval of 0.87 to 1.8.

Background

The study evaluated pembrolizumab, also identified as Keytruda, in participants with high-risk resected melanoma. The trial covered Stage IIB, IIC, III, and IV disease. Its stated purpose was to compare pembrolizumab/vibostolimab, also called MK-7684A, with pembrolizumab alone as adjuvant treatment after melanoma resection.

Trial design

This was a phase 3 study listed under the condition melanoma. It enrolled 1,594 participants and included two intervention groups: pembrolizumab/vibostolimab and pembrolizumab. The primary objective was to compare the groups for recurrence-free survival, assessed by investigators. The study’s primary hypothesis stated that pembrolizumab/vibostolimab would be superior to pembrolizumab for recurrence-free survival in participants with high-risk resected Stage IIB, IIC, III, and IV melanoma. The record listed the overall status as terminated.

Key results

The posted recurrence-free survival measurements listed the median as NA months for both the pembrolizumab/vibostolimab group and the pembrolizumab group. No confidence-interval values were provided for those median measurements.

A comparative analysis reported a hazard ratio of 1.25 with a 95% confidence interval of 0.87 to 1.8. The supplied record did not provide a p-value, specify the analysis method, or identify an outcome title for that hazard-ratio entry. No adverse-event summary was included in the supplied data.

What this means

The record documents primary completion of a large phase 3 comparison, but the supplied results do not include median recurrence-free survival values or their confidence intervals. The reported hazard ratio was above 1, while its confidence interval extended from below 1 to above 1. Without a p-value, additional analysis details, or complete outcome reporting, these data alone do not establish whether the combination improved recurrence-free survival over pembrolizumab alone.

Source

This article is based on the ClinicalTrials.gov study record for NCT05665595, with the event dated 2024-03-06. The source document is the ClinicalTrials.gov trial record, available at clinicaltrials.gov.