A Phase 1 Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Subjects With Select Advanced Solid Tumors

Sponsor
Bristol-Myers Squibb
Study ID
NCT02516527
Phase
PHASE1
Status
Completed

Conditions

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 ipilimumab is effective in the treatment of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.

Key Dates

Start date
Oct 16, 2015
Status verified
Apr 2020
Primary completion
Sep 20, 2018
Completion
Sep 20, 2018

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Induction Phase:Ipilimumab
    Ipilimumab dose as specified
  • Experimental: Maintenance Phase:Ipilimumab
    Ipilimumab dose as specified

Primary Outcome Measure

The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths [ Time Frame: Up to 90 days post discontinuation of dosing ]

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