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 Skin Cancer/Melanoma Immunotherapy

Summary

Eligibility
for people ages 15 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Adil Daud (ucsf)
Headshot of Adil Daud
Adil Daud

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

You can join if…

Open to people ages 15 years and up

  • 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

You CAN'T join if...

  • 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

  • Local Institution - 0006
    San Francisco California 94143 United States
  • Local Institution - 0189
    Los Angeles California 90025 United States
  • Local Institution - 0021
    San Francisco California 94109 United States
  • Local Institution - 0117
    La Jolla California 92093-0698 United States

Lead Scientist at University of California Health

  • Adil Daud (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 201 research publications

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
About 906 people participating
Last Updated