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

Withdrawn before enrolling · Phase 2

Conditions studied: Renal Cell Carcinoma, Melanoma, Lung Cancer

In brief

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

Key facts

Study ID

NCT02763761

Run by

Bristol-Myers Squibb

People needed

0

Starts

2016-08-16

Expected to finish

2017-03-31

Last updated by the study team

2018-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.