An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

  • Interventional
  • Not Recruiting
  • NCT03068455
Eligibility Details Visit Clinicaltrials.gov

A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

Gender
All

Age Group
12 Years and up

Accepting Healthy Volunteers?
No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

        Inclusion Criteria:

         - Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.

         - Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work

         - No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)

        Exclusion Criteria:

         - History of uveal melanoma

         - Patients with active, known or suspected autoimmune disease

         - Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT03068455

IRB#IRB17-0235

Lead SponsorBristol-Myers Squibb

Lead PhysicianThomas F. Gajewski

Collaborator(s)N/A

EligibilityAll
12 Years and up
Not Recruiting