Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)
Study ID: NCT02763761
Study Description
Brief 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
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles, Los Angeles, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
University of Louisville, Louisville, Kentucky, United States
University of Michigan, Ann Arbor, Michigan, United States
Atlantic Health System, Morristown, New Jersey, United States
Local Institution, Albuquerque, New Mexico, United States
NYU Langone Medical Center, New York, New York, United States
Huntsman Cancer Institute at The University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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