Clinical Trial

A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated April 13, 2025 (before its estimated February 23, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study is a randomized, double-blind, multi-center phase III clinical study to compare the efficacy and safety of penpulimab combined with chemotherapy and placebo combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2021-07-21; most recent amendment 2025-04-10.
Status change: Recruiting → Active, Not Recruiting 2025-02-24
Status change: Enrolling by Invitation → Recruiting 2022-07-05
Status change: Recruiting → Enrolling by Invitation 2022-03-28
Trial Details
NCT Number NCT04974398
Lead Sponsor Akeso
Conditions Nasopharyngeal Carcinoma
Enrollment 296 participants
Start Date 2021-08-16
Primary Completion 2026-02-23 (estimated)
Study Completion 2026-12-23 (estimated)
Updated on ClinicalTrials.gov 2025-04-13