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)
Withdrawn prior to enrolment
Phase of Trial: Phase II
Latest Information Update: 31 Aug 2017
At a glance
- Drugs Infliximab (Primary) ; Methylprednisolone (Primary) ; Prednisone (Primary)
- Indications Diarrhoea
- Focus Therapeutic Use
- Sponsors Bristol-Myers Squibb
- 25 Aug 2017 Planned End Date changed from 17 Sep 2019 to 31 Mar 2017.
- 25 Aug 2017 Planned primary completion date changed from 16 Dec 2018 to 21 Mar 2017.
- 25 Aug 2017 Planned initiation date changed from 1 Dec 2016 to 16 Aug 2016.