An Investigational Study of Infliximab With Prednisone or Methylprednisolone Versus Prednisone Combination Treatment in Immune Related or Severe Diarrhea in Patients Treated With Yervoy and/or Opdivo
An Investigational Study of Infliximab With Prednisone or Methylprednisolone Versus Prednisone Combination Treatment in Immune Related or Severe Diarrhea in Patients Treated With Yervoy and/or Opdivo
The purpose of this study is to compare the effects of Infliximab and oral prednisone versus
 methylprednisolone and oral prednisone in patients with melanoma, lung cancer, or renal cell
 carcinoma who have immune related Grade 3-4 diarrhea for up to 3 days or persistent Grade 2
 diarrhea for more than 5 days after treatment with Yervoy and/or Opdivo
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
 visit www.BMSStudyConnect.com

 Inclusion Criteria:

 -  Subjects must have melanoma or lung cancer or renal cell carcinoma and received
 ipilimumab or nivolumab as a single treatment or in combination

 -  Subject must have NCI common toxicity Grade 3-4 immune-related diarrhea for up to 3
 days or persistent Grade 2 diarrhea for more than 5 days

 -  Subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the
 combination regimen

 Exclusion Criteria:

 -  Subjects who received other anti Cytotoxic T-lymphocytic antigen (CTLA-4)
 (non-ipilimumab) or other anti-Programmed death-1 (PD-1) (non-nivolumab) treatment

 -  Subjects treated with systemic Corticosteroid (CST) within 1 week before randomization
 and subjects treated with infliximab within 7 weeks before randomization

 -  Subjects with known history of tuberculosis

 -  Subjects with immunosuppressive disease that require use of systemic steroids or
 immunosuppressive treatment

 -  Subjects allergic to infliximab, inactive components of infliximab, murine proteins
 and methylprednisolone

 Other protocol defined inclusion/exclusion criteria could apply