A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 02 Feb 2018
At a glance
- Drugs Nivolumab (Primary) ; Ipilimumab
- Indications Malignant melanoma
- Focus Registrational; Therapeutic Use
- Acronyms CheckMate 238
- Sponsors Bristol-Myers Squibb
- 22 Dec 2017 According to an Ono Pharmaceutical media release, supplemental application is aiming to change the current dosage and administration of infuse 3 mg/kg (body weight) every 2 weeks over 1 hour intravenously to infuse at 240 mg every 2 weeks over 30 minutes intravenously.
- 22 Dec 2017 According to an Ono Pharmaceutical media release, based on the result of this trial the company has submitted a supplemental application of Opdivo Intravenous Infusion 20 mg and 100 mg, in Japan for expanded use of the adjuvant treatment of patients with melanoma, for a partial change in approved items of the manufacturing and marketing approval.
- 20 Dec 2017 According to a Bristol-Myers Squibb media release, the FDA has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History