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A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

Study acronym: AK104-305
StatusActive, Not Recruiting
PhasePhase 3
SponsorAkeso
Started2022-06-21
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 13, 2024 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-08-12
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Study sites10→9
2022-08-22
notable
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-03→confirmed 2022-06-21
Study sites9→10
Secondary endpoints2 entries, revised
Overall Survival(OS)
Primary endpoints1 entry, revised
Progression-Free Survival(PFS) by investigator(INV)
2022-02-10
minor
Original filing
96 trials monitored
See 1 trial at risk
853 trials monitored
See 46 trials at risk
This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer
Trial Details
NCT Number NCT05235516
Lead Sponsor Akeso
Conditions Locally Advanced Cervical Carcinoma
Enrollment 636 participants
Start Date 2022-06-21
Primary Completion 2026-05 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2024-08-13