MedTrace Logo

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

NCT04974398 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2025-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Chaosu Hu, MD · Fudan University

  • Xiaozhong Chen, MD · Cancer Hospital of The University of Chinese Academy of Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2026-02-23
Completion
2026-12-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04974398 on ClinicalTrials.gov