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Withdrawn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

Arm | Intervention/treatment |
---|---|
Experimental: Infliximab + Prednisone
Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
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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 |
- 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 ]
- 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 ]
- Number of days to improvement to less than grade 1 diarrhea [ Time Frame: Randomization up to 12 weeks ]
- Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D) [ Time Frame: Up to 12 weeks ]
- Number of hospitalizations [ Time Frame: Up to 12 weeks ]
- Duration of hospitalizations [ Time Frame: Up to 12 weeks ]
- Number of patients with adverse events (AEs) [ Time Frame: Up to 12 weeks ]
- Number of patients with AEs related to steroid use [ Time Frame: Up to 12 weeks ]
- Number of patients with Gastrointestinal (GI) specific AEs [ Time Frame: Up to 12 weeks ]

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

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
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |