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

October 5, 2018 updated by: Bristol-Myers Squibb

A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Winship Cancer Institute, Emory University
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Atlantic Health System
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Local Institution
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at the University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Infliximab + Prednisone
Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
Drug: Infliximab + Prednisone
Prednisone dose will be decreased every 3 days for 18 days
EXPERIMENTAL: Methylprednisolone + Prednisone
Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days
Drug: Methylprednisolone + Prednisone
Prednisone dose will be decreased every 4 days for 40 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to 78 hours
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
Time Frame: Up to 78 hours
Up to 78 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 16, 2016

Primary Completion (ANTICIPATED)

March 31, 2017

Study Completion (ANTICIPATED)

March 31, 2017

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (ESTIMATE)

May 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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