Lung Cancer Clinical Trial

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

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

View Eligibility Criteria

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT02763761

Recruitment Status:

Withdrawn

Sponsor:

Bristol-Myers Squibb

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There are 10 Locations for this study

See Locations Near You

University of California Los Angeles
Los Angeles California, 90024, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
University of Louisville
Louisville Kentucky, 40202, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Atlantic Health System
Morristown New Jersey, 07962, United States
Local Institution
Albuquerque New Mexico, 87131, United States
NYU Langone Medical Center
New York New York, 10016, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT02763761

Recruitment Status:

Withdrawn

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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