Clinical Trial 19124

Cancer Type: Cutaneous
Interventions:BMS-936558 (Nivolumab); Ipilimumab; Nivolumab; Not Applicable; Placebo; Yervoy (Ipilimumab)

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Nikhil Khushalani

Overview

Study Title

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

Summary

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.

Objective

To compare the efficacy, as measured by recurrence free survival (RFS), provided by Nivolumab plus Ipilimumab versus Ipilimumab alone and Nivolumab alone in participants with completely resected stage IIIb/c/d or stage IV no evidence of disease (NED) melanoma

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)
  • Other protocol defined inclusion criteria could apply

  • Exclusion Criteria

  • History of uveal melanoma
  • Weight less than or equal to 40 kg
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with interferon (if complete less than 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 exclusion criteria could apply