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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

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ClinicalTrials.gov Identifier: NCT02763761
Recruitment Status : Withdrawn (Insufficient enrollment)
First Posted : May 5, 2016
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Melanoma Lung Cancer Drug: Infliximab + Prednisone Drug: Methylprednisolone + Prednisone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 16, 2016
Estimated Primary Completion Date : March 31, 2017
Estimated Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Steroids

Arms and Interventions
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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


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

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763761


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90024
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322-1013
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07962
United States, New Mexico
Local Institution
Albuquerque, New Mexico, United States, 87131
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
United States, Utah
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02763761    
Other Study ID Numbers: CA209-601
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Diarrhea
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Signs and Symptoms, Digestive
Prednisone
 Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Infliximab
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents