Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601335
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma RM HNSCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Multicenter Phase 3 Study of AK112 in Combination with AK117 Versus Pembrolizumab As First Line Treatment for a Programmed Cell Death-ligand 1 PD-L1 Positive Population with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma RM HNSCC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 3 study All subjects arerecurrent or metastatic head and neck squamous Cell Carcinoma RM HNSCC Eastern Cooperative Oncology Group ECOG performance status 0-1 The purpose of this study is to evaluate the efficacy and safety of AK112 combined with AK117 versus pembrolizumab combined with placebo in patients with RM HNSCC whose tumors have programmed cell death-ligand 1 PD-L1 positive Combined Positive Score CPS greater than or equal to 1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None