A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors (CheckMate 077)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02593786

CA209-077

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese subjects with advanced or recurrent solid tumors

Exclusion criteria

• Subjects with brain metastases are excluded unless clinically stable for more than 2 weeks at the time of enrollment as determined by the investigator
• Subjects with carcinomatous meningitis are excluded

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Nivolumab monotherapy

Experimental group

Description:

Nivolumab specified dose on specified days

Treatment:

Drug: Nivolumab

Cohort Expansion

Experimental group

Description:

Nivolumab specified dose on specified days

Treatment:

Drug: Nivolumab