Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 10:25 PM
Study NCT ID:
NCT04659369
Status:
TERMINATED
Last Update Posted:
2024-04-09
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
Sponsor:
Taizhou Mabtech Pharmaceutical Co.,Ltd
Organization:
Study Overview
Official Title:
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficult to recruit subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the pharmacokinetic, safety, immunogenicity and efficacy of CMAB819 and Nivolumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma., after failure of prior platinum-based chemotherapy.
Detailed Description:
Patients were randomized to receive CMAB819 or Nivolumab 480 mg by intravenous infusion every 4 weeks until documented disease progression, discontinuation, withdrawal of consent, or up to 4 doses in subjects without disease progression, whichever occurs earlier. After completing 4 doses of therapy, administer of CMAB819 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status ECOG (0 versus 1), sex (male versus female), weight （≤60 kg versus \>60kg）and clinical trial institution (up to 20 centers) .
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: