A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread

Sponsor
Bristol-Myers Squibb
Study ID
NCT03158272
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignancies

Eligibility Criteria

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

Interventions

  • Cabiralizumab — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.

Key Dates

Start date
May 25, 2017
Status verified
Nov 2020
Primary completion
Oct 23, 2019
Completion
Oct 23, 2019

Study Design

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

Arms

  • Experimental: Monotherapy
    Cabiralizumab administered as a single agent intravenous formulation
  • Experimental: Combination Therapy
    Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy [ Time Frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months ]

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