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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Prednisone dose will be decreased every 3 days for 18 days
Prednisone dose will be decreased every 4 days for 40 days
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
Improvement in management of immune related grade 3 and 4 diarrhea as measured by proportion of responders to less than or equal to grade 1
Time frame: Up to 78 hours
Improvement in management of persistent grade 2 diarrhea as measured by proportion of responders to less than or equal to grade 1
Time frame: Up to 78 hours
Number of days to improvement to less than grade 1 diarrhea
Time frame: Randomization up to 12 weeks
Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Time frame: Up to 12 weeks
Number of hospitalizations
Time frame: Up to 12 weeks
Duration of hospitalizations
Time frame: Up to 12 weeks
Number of patients with adverse events (AEs)
Time frame: Up to 12 weeks
Number of patients with AEs related to steroid use
Time frame: Up to 12 weeks
Number of patients with Gastrointestinal (GI) specific AEs
Time frame: Up to 12 weeks
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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