MedPath

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Withdrawn
Conditions
Renal Cell Carcinoma
Melanoma
Lung Cancer
Interventions
Registration Number
NCT02763761
Lead Sponsor
Bristol-Myers Squibb
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

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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
Read More
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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Infliximab + PrednisoneInfliximab + PrednisoneInfliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
Methylprednisolone + PrednisoneMethylprednisolone + PrednisoneMethylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days
Primary Outcome Measures
NameTimeMethod
Improvement in management of immune related grade 3 and 4 diarrhea as measured by proportion of responders to less than or equal to grade 1Up to 78 hours
Improvement in management of persistent grade 2 diarrhea as measured by proportion of responders to less than or equal to grade 1Up to 78 hours
Secondary Outcome Measures
NameTimeMethod
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 diarrheaRandomization up to 12 weeks
Number of patients with Gastrointestinal (GI) specific AEsUp to 12 weeks
Number of hospitalizationsUp to 12 weeks
Duration of hospitalizationsUp to 12 weeks
Number of patients with AEs related to steroid useUp to 12 weeks

Trial Locations

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

© Copyright 2025. All Rights Reserved by MedPath