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
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | — | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | — | Intravenous |
| Subject | Prednisone | Other / unclassified | — | Oral |