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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

Primary Purpose

Renal Cell Carcinoma, Melanoma, Lung Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Infliximab + Prednisone
Methylprednisolone + Prednisone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Los Angeles
  • University of Colorado Cancer Center
  • H Lee Moffitt Cancer Center and Research Institute
  • Winship Cancer Institute, Emory University
  • University of Louisville
  • University of Michigan
  • Atlantic Health System
  • Local Institution
  • NYU Langone Medical Center
  • Huntsman Cancer Institute at The University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Infliximab + Prednisone

Methylprednisolone + Prednisone

Arm Description

Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days

Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days

Outcomes

Primary Outcome Measures

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
Improvement in management of persistent grade 2 diarrhea as measured by proportion of responders to less than or equal to grade 1

Secondary Outcome Measures

Number of days to improvement to less than grade 1 diarrhea
Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Number of hospitalizations
Duration of hospitalizations
Number of patients with adverse events (AEs)
Number of patients with AEs related to steroid use
Number of patients with Gastrointestinal (GI) specific AEs

Full Information

First Posted
May 4, 2016
Last Updated
October 5, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02763761
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient enrollment
Study Start Date
August 16, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Anticipated)
Study Completion Date
March 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Melanoma, Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infliximab + Prednisone
Arm Type
Experimental
Arm Description
Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
Arm Title
Methylprednisolone + Prednisone
Arm Type
Experimental
Arm Description
Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days
Intervention Type
Drug
Intervention Name(s)
Infliximab + Prednisone
Intervention Description
Prednisone dose will be decreased every 3 days for 18 days
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone + Prednisone
Intervention Description
Prednisone dose will be decreased every 4 days for 40 days
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Number of days to improvement to less than grade 1 diarrhea
Time Frame
Randomization up to 12 weeks
Title
Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Time Frame
Up to 12 weeks
Title
Number of hospitalizations
Time Frame
Up to 12 weeks
Title
Duration of hospitalizations
Time Frame
Up to 12 weeks
Title
Number of patients with adverse events (AEs)
Time Frame
Up to 12 weeks
Title
Number of patients with AEs related to steroid use
Time Frame
Up to 12 weeks
Title
Number of patients with Gastrointestinal (GI) specific AEs
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
H Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Local Institution
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Huntsman Cancer Institute at The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this 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

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