Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)

  • Interventional
  • Not Recruiting
  • NCT02388906
Eligibility Details Visit Clinicaltrials.gov

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)

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

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

Gender
All

Age Group
15 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02388906

IRB#IRB15-0014

Lead SponsorBristol-Myers Squibb

Lead PhysicianThomas F. Gajewski

Collaborator(s)N/A

EligibilityAll
15 Years and up
Not Recruiting