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

Phase 2

Withdrawn

Interventions: Drug: Infliximab + Prednisone
Drug: Methylprednisolone + Prednisone

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Infliximab + Prednisone	Infliximab + Prednisone	Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
Methylprednisolone + Prednisone	Methylprednisolone + Prednisone	Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days

Primary Outcome Measures

Name	Time	Method
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	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	Up to 78 hours

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events (AEs)	Up to 12 weeks
Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)	Up to 12 weeks
Number of days to improvement to less than grade 1 diarrhea	Randomization up to 12 weeks
Number of patients with Gastrointestinal (GI) specific AEs	Up to 12 weeks
Number of hospitalizations	Up to 12 weeks
Duration of hospitalizations	Up to 12 weeks
Number of patients with AEs related to steroid use	Up to 12 weeks

Locations (10): Atlantic Health System
🇺🇸
Morristown, New Jersey, United States
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
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Huntsman Cancer Institute at The University of Utah
🇺🇸
Salt Lake City, Utah, United States
Winship Cancer Institute, Emory University
🇺🇸
Atlanta, Georgia, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Local Institution
🇺🇸
Albuquerque, New Mexico, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States