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Summary

for people ages 15 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

Official Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

Details

Italy, Greece, and Argentina: ≥ 18 years of age

Keywords

Melanoma Nivolumab Antibodies, Monoclonal

Eligibility

For people ages 15 years and up

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

Inclusion Criteria:

  • At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
  • Completely removed melanoma by surgery performed within 12 weeks of randomization
  • Stage IIIb/C or Stage IV before complete resection
  • No previous anti-cancer treatment

Exclusion Criteria:

  • Ocular or uveal melanoma
  • History of carcinomatosis meningitis
  • History of auto-immune disease
  • Treatment directed against the resected melanoma that is administrated after the surgery

Locations

  • San Francisco Oncology Associates
    San Francisco, California, 94115, United States
  • The Angeles Clinic & Research Institute
    Los Angeles, California, 90025, United States

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
ID
NCT02388906
Phase
Phase 3
Lead Scientist
Adil Daud
Study Type
Interventional
Last Updated
August 2016