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NCT04974398 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Nasopharyngeal Carcinoma, sponsored by Akeso.

Active
Registry status
Phase 3
Development phase
296
Enrollment target
20
Study locations

NCT04974398 is a Phase 3 study of Nasopharyngeal Carcinoma that is active but no longer recruiting, run by Akeso. The registered enrollment target is 296 participants, above the 58-participant average among 7 other Nasopharyngeal Carcinoma trials with a reported enrollment target (410% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT04974398, a Phase 3 study of Nasopharyngeal Carcinoma, is active but no longer recruiting, sponsored by Akeso.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
296 participants
Enrollment target
20
Study locations

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 Studied

Nasopharyngeal Carcinoma

Interventions

  • DRUG placebo
  • DRUG Penpulimab

Study Locations (20)

REG1

  • Hospital de Câncer de Barretos - Fundação Pio XII - Barretos
  • Grupo Oncoclínicas - Botafogo
  • Hospital Bruno Born - Lajeado
  • Hospital Nossa Senhora da Conceicao - Porto Alegre
  • Centro de Estudos e Pesquisa de Hematologia - Santo André
  • Instituto do Câncer do Estado de São Paulo (ICESP) - São Paulo
  • Centro de Câncer A. C. Camargo - São Paulo

New South Wales

  • Chris O'Brien Lifehouse - Camperdown
  • St Vincent's Public Hospital Sydney - Darlinghurst
  • Genesis Care North Shore - St Leonards

New York

  • Icahn School of Medicine at Mount Sinai - New York
  • Memorial Sloan Kettering Cancer Center - New York

California

  • City of Hope - Duarte

Georgia

  • Winship Cancer Institute/Emory University - Atlanta

Michigan

  • University of Michigan - Ann Arbor

Victoria

  • Sir Charles Gardner - Heidelberg

Western Australia

  • Austin Health - Nedlands

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2021-08-16
Est. Completion 2026-12-23
Phase Phase 3

Sponsor

Akeso

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04974398

The ClinicalTrials.gov registry entry for NCT04974398 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 58-participant average among 7 other Nasopharyngeal Carcinoma trials with a reported enrollment target (410% higher). The listed sponsor is Akeso, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Nasopharyngeal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT04974398 reports 20 study locations spanning 11 distinct geographic areas - top geographies include REG1, New South Wales, New York.

Frequently Asked Questions

What is clinical trial NCT04974398 about?

NCT04974398 is a clinical study titled "A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma". 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.

What is the current status of trial NCT04974398?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2021-08-16. Estimated completion is 2026-12-23.

What conditions does trial NCT04974398 study?

This clinical trial studies the following conditions: Nasopharyngeal Carcinoma.

What interventions are being tested in trial NCT04974398?

The interventions under investigation include: placebo (DRUG), Penpulimab (DRUG).

Who is sponsoring clinical trial NCT04974398?

This trial is sponsored by Akeso, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04974398 being conducted?

This trial has 20 study locations across California, Georgia, Michigan, New York, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.