Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459687
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-03
Brief Title:
Phase III Study of Socazolimab as First-Line Treatment in Persistent Recurrent or Metastatic Cervical Cancer
Sponsor:
Lees Pharmaceutical Limited
Organization:
Lees Pharmaceutical Limited
Study Overview
Official Title:
Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent Recurrent or Metastatic Cervical Cancer A Randomized Double-blind Placebo-controlled Phase III Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent recurrent or metastatic cervical cancer The main question it aims to answer is
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent recurrent or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab
Participants will be treated with Socazolimabplacebo chemotherapy bevacizumab for 68 cycles Q3w following maintenance treatment of Socazolimabplacebo Q3w
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent recurrent or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab
Participants will be treated with Socazolimabplacebo chemotherapy bevacizumab for 68 cycles Q3w following maintenance treatment of Socazolimabplacebo Q3w
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None