drugset
drugset / Trial / NCT02763761

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

NCT02763761 ↗

Phase 2 Withdrawn Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2016-08-16
Primary completion
2017-03-31
Completion
2017-03-31

Outcome

Outcome not reported

Stopped (Enrollment): “Insufficient enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody — Intravenous
Subject Methylprednisolone Other / unclassified — Intravenous
Subject Prednisone Other / unclassified — Oral

Indications

lung cancer melanoma renal cell carcinoma