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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab + Prednisone | Experimental | Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days |
|
| Methylprednisolone + Prednisone | Experimental | Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab + Prednisone | Drug | Prednisone dose will be decreased every 3 days for 18 days |
|
| Measure | Description | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90024 | United States | ||
| University of Colorado Cancer Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Methylprednisolone + Prednisone | Drug | Prednisone dose will be decreased every 4 days for 40 days |
|
| 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 |
| Number of patients with AEs related to steroid use | Up to 12 weeks |
| Number of patients with Gastrointestinal (GI) specific AEs | Up to 12 weeks |
| 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 |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D008545 | Melanoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
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