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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedInfliximab + Prednisone and Methylprednisolone + Prednisone

The study team can explain what participation involves.

Who it may be forRenal Cell Carcinoma · Melanoma

These are broad labels—not an eligibility decision.

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

Is enrollment open?Withdrawn

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What kind of study?Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

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

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How this study is categorized

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

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion 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/

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

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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