This study is in progress, not accepting new patients

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

a study on Melanoma Skin Cancer/Melanoma Immunotherapy

Summary

Eligibility
for people ages 15 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
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)

Keywords

Melanoma Recurrence Nivolumab Ipilimumab

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

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • UC San Diego Moores Cancer Ctr
    La Jolla California 92093-0698 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 Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT02388906
Phase
Phase 3 Research Study
Study Type
Interventional
Participants
At least 906 people participating
Last Updated