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

NCT03855384 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2019-10-30

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2020-12-31
Completion
2021-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03855384 on ClinicalTrials.gov