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

Sponsor
Bristol-Myers Squibb
Study ID
NCT02593786
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 7, 2016
Status verified
Sep 2022
Primary completion
Sep 27, 2021
Completion
Sep 27, 2021

Study Design

Enrollment
58 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab monotherapy
    Nivolumab specified dose on specified days
  • Experimental: Cohort Expansion
    Nivolumab specified dose on specified days

Primary Outcome Measure

The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs) [ Time Frame: From first dose to 100 days after last dose (up to approximately 28 months) ]

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