NCT04974398

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

A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Penpulimab	Arm A: Penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) +cisplatin (80 mg/m2) or carboplatin (AUC 5) (administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/ m2, administered on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), 3 weeks (21 days) per cycle; followed by penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) as maintenance treatment.
DRUG	placebo	Arm B: Placebo (200 mg, administered on Day 1 of each cycle, Q3W) + cisplatin (80 mg/m2) or carboplatin (AUC 5) (administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/m2, administered on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), every 3 weeks (21 days) per cycle; followed by placebo(200 mg, administered on Day 1 of each cycle, Q3W) as maintenance treatment. Subjects in Arm B will have the opportunity to crossover to openlabel treatment with penpulimab monotherapy after radiographic disease progression.

Timeline

• Start date: 2021-08-16
• Primary completion: 2026-02-23
• Completion: 2026-12-23
• First posted: 2021-07-23
• Last updated: 2025-04-13

Locations

56 sites across 5 countries: United States, Australia, Brazil, Canada, China

Regulatory

• FDA-regulated drug study