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Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC

NCT04659369 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

CMAB819

for injection only

DRUG

Nivolumab

for injection only

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Ye Guo, Ph.D · Shanghai East Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2023-10-16
Completion
2023-10-16

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04659369 on ClinicalTrials.gov