Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

Official Title

A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

Keywords

Unresectable or Metastatic MelanomaMelanomaPaclitaxelAlbumin-Bound PaclitaxelCarboplatinNivolumabBMS-936558DacarbazineBMS-936558 3 mg/kg (IV)

Eligibility

For people ages 18 years and up

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

Inclusion Criteria:

  • Men & women ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Histologically confirmed Stage III (unresectable)/Stage IV melanoma
  • Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
  • Pre-treatment fresh core, excision or punch tumor biopsy
  • Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

Exclusion Criteria:

  • Any treatment in a BMS-936558 (Nivolumab) trial
  • Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
  • Active, known or suspected autoimmune disease
  • Unknown BRAF status
  • Active brain metastasis or leptomeningeal metastasis
  • Ocular melanoma
  • Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)

Locations

  • UCSD Moores Cancer Center
    La JollaCalifornia92093United States
  • The Angeles Clinic & Research Institute
    Los AngelesCalifornia90025United States
  • University Of California - Los Angeles
    Los AngelesCalifornia90095United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT01721746
Phase
Phase 3
Study Type
Interventional
Last Updated