NCT03855384

Study of TQB2450 in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck（R/M SCCHN）

Multicenter, Randomized, Double-blind, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of TQB2450 Plus Chemotherapy（Cisplatin or Carboplatin+ 5-Fluorouracil (5-FU) ） Versus Placebo Plus Chemotherapy as First-Line Treatment in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma（R/M SCCHN）

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)	TQB2450 1200mg IV ，cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).
DRUG	placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)	placebo 1200mg IV ，cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).

Timeline

• Start date: 2019-06-11
• Primary completion: 2020-12-31
• Completion: 2021-05-30
• First posted: 2019-02-26
• Last updated: 2019-10-30

Locations

1 site across 1 country: China