A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors

Sponsor
Bristol-Myers Squibb
Study ID
NCT03203876
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Lirilumab — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors

Key Dates

Start date
Jul 14, 2017
Status verified
Mar 2022
Primary completion
Aug 6, 2020
Completion
Aug 6, 2020

Study Design

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

Arms

  • Experimental: Part One Combination Therapy
    Lirilumab and Nivolumab
  • Experimental: Part 2 Combination Therapy
    Lirilumab, Nivolumab and Ipilimumab

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ]

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