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
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Bristol-Myers Squibb
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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
Research Team
BS
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
Inclusion Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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
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Treatment Details
Interventions
- Infliximab (Monoclonal Antibodies)
- Methylprednisolone (Corticosteroid)
- Prednisone (Corticosteroid)
- Yervoy, Opdivo (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Methylprednisolone + PrednisoneExperimental Treatment1 Intervention
Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days
Group II: Infliximab + PrednisoneExperimental Treatment1 Intervention
Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Local InstitutionAlbuquerque, NM
University of MichiganAnn Arbor, MI
Atlantic Health SystemMorristown, NJ
Huntsman Cancer Institute at The University of UtahSalt Lake City, UT
More Trial Locations
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Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Trials
2731
Patients Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia