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

StatusActive, Not Recruiting
PhasePhase 3
SponsorAkeso
Started2021-08-16
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 13, 2025 (before its estimated February 23, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-04-10
Study Status, Arms and Interventions, Eligibility, IPDSharing v15
Eligibility criteria-31 characters
[...] are not suitable for local treatment or radical treatment; or nasopharyngeal carcinoma subjects who have a local-regional recurrence and/or distant metastasis more than 6 months after the endcompletion of previousprior radical treatment (radiotherapy with induction, concurrent, [...] mic treatment has been received for recurrent or metastatic nasopharyngeal carcinomadiseases, and local regional recurrence is not suitableamendable forto local treatment or hashave received local treatment. for the local-regional recurrent disease At least one measurable lesion according to RECIST v1.1; Ha [...]
2025-02-24
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v14
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-02-28→2026-02-23
Completion date2026-09-15→2026-12-23
Enrollment targetestimated 278→confirmed 296
Study sitesdetails revised at 56 of 56 sites
2024-10-12
Study Status, Study Design v13
Enrollment target298→278
2024-04-02
Study Status v12
Primary completion date2023-12-30→2025-02-28
2023-12-10
Study Status, Contacts/Locations v11
Study sitesdetails revised at 12 of 56 sites
Show 10 earlier versions
2023-07-18
Study Status, Contacts/Locations v10
Study sites45→56
2023-02-16
Study Status, Contacts/Locations v9
Study sites43→45
2023-01-03
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 43 sites
2022-11-10
Study Status, Contacts/Locations v7
Primary completion date2023-07→2023-12-30
Completion date2025-10→2026-09-15
Study sites41→43
2022-09-30
Study Status, Contacts/Locations v6
Study sites42→41
2022-08-11
Study Status, Arms and Interventions, Contacts/Locations v5
Study sites39→42
2022-07-05
Enrolling by Invitation→Recruiting Study Status, Contacts/Locations v4
Trial statusEnrolling by Invitation→Recruiting
Study sites39 entries, revised
Memorial Sloan Kettering Cancer Center
2022-06-12
Study Status, Arms and Interventions, Contacts/Locations v3
Study sites39 entries, revised
HospitalMemorial UmumSloan SarawakKettering
2022-03-28
Recruiting→Enrolling by Invitation Study Status, Study Design, Eligibility, Contacts/Locations v2
Trial statusRecruiting→Enrolling by Invitation
Start date2021-08-13→2021-08-16
Enrollment target278→298
Study sites29→39
Eligibility criteria+54 characters
Inclusion Criteria: Voluntarily signed written Informed Consent Form(ICF). Main study: Age of ≥ 18 years and ≤ 75 years at the time of enrollment, male or female. Substudy: Age of ≥ 12 years and < 18 years. Weight≥ 35KG. Eastern Cooperative Oncology Group (ECOG) performance status [...]
2021-08-25
Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Start dateestimated 2021-08-01→confirmed 2021-08-13
Study sites9→29
Eligibility criteria+23 characters
Inclusion Criteria: Voluntarily signed written Informed Consent Form(ICF). Age of ≥ 18 years and ≤ 75 years at the time of enrollment [...]
Secondary endpoints9 entries, revised
Overall survival(OS) Objective response rate (ORR) Duration of response (DoR) Disease control rate (DCR) Adverse event (AE)
2021-07-21
Original filing
Akeso
96 trials monitored
See 1 trial at risk
Head & Neck Cancer
2,051 trials monitored
See 116 trials at risk
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.
Trial Details
NCT Number NCT04974398
Lead Sponsor Akeso
Conditions Nasopharyngeal Carcinoma
Enrollment 296 participants
Start Date 2021-08-16
Primary Completion 2026-02-23 (estimated)
Study Completion 2026-12-23 (estimated)
Updated on ClinicalTrials.gov 2025-04-13