Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT04974398 · View on ClinicalTrials.gov ↗

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

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

31 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akeso, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04974398 reports 20 study locations spanning 11 distinct geographic areas — top geographies include REG1, New South Wales, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04974398?

The interventions under investigation include: placebo (DRUG), Penpulimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04974398?

This trial is sponsored by Akeso, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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