Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Nasopharyngeal Carcinoma, sponsored by Akeso.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS assessed by BIRC based on RECIST v1.1 .
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
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2026-12-23 |
| Phase | Phase 3 |
What the registry record for NCT04974398 still lists
NCT04974398 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 58-participant average among 7 other Nasopharyngeal Carcinoma trials with a reported enrollment target (410% higher).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Nasopharyngeal Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Gemcitabine + Docetaxel + Toripalimab Induction in Epstein-Barr Virus (EBV) Associated Nasopharyngeal Carcinoma(NPC)
RECRUITING · Phase 2
-
Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
RECRUITING · NA
-
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
ACTIVE NOT RECRUITING · Phase 1
-
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
ACTIVE NOT RECRUITING · Phase 1
-
Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)
ACTIVE NOT RECRUITING · Phase 1
-
Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05563792 · 296 participants · NA
Options for Pain Management Using Nonpharmacological Strategies
- NCT06828445 · 296 participants · Phase 1
Increasing Affordable Fruits and Vegetables for Families With Food Insecurity
- NCT06920563 · 296 participants · NA
Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education
- NCT06309160 · 297 participants · NA
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI