Study Stopped
Insufficient enrollment
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
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)
1 other identifier
interventional
N/A
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2016
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedStudy Start
First participant enrolled
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedOctober 9, 2018
October 1, 2018
8 months
May 4, 2016
October 5, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Up to 78 hours
Secondary Outcomes (7)
Number of days to improvement to less than grade 1 diarrhea
Randomization up to 12 weeks
Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Up to 12 weeks
Number of hospitalizations
Up to 12 weeks
Duration of hospitalizations
Up to 12 weeks
Number of patients with adverse events (AEs)
Up to 12 weeks
- +2 more secondary outcomes
Study Arms (2)
Infliximab + Prednisone
EXPERIMENTALInfliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
Methylprednisolone + Prednisone
EXPERIMENTALMethylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days
Interventions
Prednisone dose will be decreased every 3 days for 18 days
Prednisone dose will be decreased every 4 days for 40 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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, 30322-1013, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 5, 2016
Study Start
August 16, 2016
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
October 9, 2018
Record last verified: 2018-10