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
| Status: | Withdrawn |
|---|---|
| Conditions: | Lung Cancer, Skin Cancer, Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/10/2018 |
| Start Date: | August 16, 2016 |
| End Date: | March 31, 2017 |
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
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
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
We found this trial at
10
sites
1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Los Angeles, California 90095
310-825-4321
Phone: 310-794-3881
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-4027
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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University of Louisville The University of Louisville is a state supported research university located in...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Phone: 801-213-4299
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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