Lung Cancer Clinical Trial
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
Summary
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
Eligibility Criteria
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
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There are 10 Locations for this study
Los Angeles California, 90024, United States
Aurora Colorado, 80045, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Louisville Kentucky, 40202, United States
Ann Arbor Michigan, 48109, United States
Morristown New Jersey, 07962, United States
Albuquerque New Mexico, 87131, United States
New York New York, 10016, United States
Salt Lake City Utah, 84112, United States
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