A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors

Phase 1/2 Completed 58 enrolled Bristol-Myers Squibb

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.

Timeline

Start: 2016-01-07
Primary completion: 2021-09-27
Completion: 2021-09-27

Publications

Ma Y, Fang W, Zhang Y, Yang Y, Hong S, Zhao Y, Tendolkar A, Chen L, Xu D, Sheng J, Zhao H, Zhang L. A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors. Oncologist. 2019 Jul;24(7):891-e431. doi: 10.1634/theoncologist.2019-0284. Epub 2019 May 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	—
Subject	Nivolumab	Monoclonal antibody	240 mg	—
Subject	Nivolumab	Monoclonal antibody	360 mg	—

A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors

Summary

Timeline

Publications

Drugs

Indications