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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

Official Title

A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

Keywords

Unresectable or Metastatic Melanoma Nivolumab Antibodies, Monoclonal

Eligibility

For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment na├»ve patients
  • Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI)per RECIST 1.1 criteria
  • Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Subjects with active, known or suspected autoimmune disease
  • Subjects with a condition requiring systemic treatment with either corticosteroids(>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
  • Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

Locations

  • California Pacific Medical Center Research Institute
    San Francisco, California, 94115, USA
  • Uc San Diego Moores Cancer Ctr
    La Jolla, California, 92093, USA
  • The Angeles Clinic And Research Institute.
    Los Angeles, California, 90025, USA
  • University Of California - Los Angeles
    Los Angeles, California, 90095, USA
  • Comprehensive Cancer Center At Desert Regional Medical Ctr
    Palm Springs, California, 92262, USA
  • Desert Hematology Oncology Medical Group
    Rancho Mirage, California, 92270, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS clinical trial educational resource
Investigator Inquiry form
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
ID
NCT01844505
Phase
Phase 3
Lead Scientist
Adil Daud
Study Type
Interventional
Last Updated
March 2017