WithdrawnPhase 2NCT02763761

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

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

Checked against the public recordLast updated Oct 9, 2018 · Source: ClinicalTrials.gov

StatusWithdrawn
PhasePhase 2
U.S. locations10
SponsorBristol-Myers Squibb
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Bristol-Myers Squibb
Interventions being studied
Drug: Infliximab + Prednisone; Drug: Methylprednisolone + Prednisone
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California Los AngelesLos Angeles, California
  • University of Colorado Cancer CenterAurora, Colorado
  • H Lee Moffitt Cancer Center and Research InstituteTampa, Florida
  • Winship Cancer Institute, Emory UniversityAtlanta, Georgia
  • University of LouisvilleLouisville, Kentucky
  • University of MichiganAnn Arbor, Michigan
  • Atlantic Health SystemMorristown, New Jersey
  • Local InstitutionAlbuquerque, New Mexico
  • NYU Langone Medical CenterNew York, New York
  • Huntsman Cancer Institute at The University of UtahSalt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2018. Always confirm current availability with the study team.

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