CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238
Research type
Research Study
Full title
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
IRAS ID
171682
Contact name
GCT-SU Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-002351-26
Duration of Study in the UK
5 years, 2 months, 3 days
Research summary
This is a multicentre, phase 3 study involving an investigational drug called nivolumab, in Subjects (≥ 15 years) with complete resection of high risk Stage III or Stage IV, No Evidence of Disease (NED) melanoma
The purpose of this study is to find out if treatment with nivolumab (or ‘Nivo’) monotherapy will improve recurrence-free survival when compared to ipilimumab (or ‘Ipi’) monotherapy in subjects with high risk for recurrence, completely resected Stage III and Stage IV NED melanoma. Ipilimumab is a drug which is approved for use in Europe for people with advanced melanoma.
Currently, there is no standard of care or no available treatment for this patient population who are status post complete resection of their lesion(s) and also at the highest risk of recurrence. Furthermore, available clinical trials for various anti-cancer agents for later stage melanoma usually require measurable disease as an eligibility criteria. Thus, there is a remaining need to improve the outcome for fully resected Stage IV patients, and a willingness to improve on the benefit/risk ratio for Stage III melanoma patients. Nivolumab is designed to work by helping the body’s own immune system attack the cancer cells.
Approximately 1050 patients will take part globally with approximately 800 patients treated (56 subjects coming from the UK). The study is sponsored by Bristol Myers Squibb.
Following a screening period, eligible patients will receive either nivolumab or ipilimumab monotherapy. This is a double blind study, so subjects and doctors will not know what medication study subjects have been assigned to. All medications are given intravenously (through a vein).
Patients will undergo the following study procedures:
CT/MRI scans,
Physical exams,
Vital signs such as blood pressure, height, weight, body temperature, oxygen levels
Blood sampling for routine safety testing and study specific testing.
ECG
Pregnancy testing
Participants will also be required to complete questionnaires at regular intervals throughout the study.The subjects will be treated in both arms until disease recurrence, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1-year total duration of study medication.
The total duration of the study from start of randomization to final analysis of Overall Survival (OS) endpoint is expected to be 63 months (15 months of recruitment + 48 months of follow-up).The study will end once survival follow-up has concluded.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0054
Date of REC Opinion
25 Feb 2015
REC opinion
Further Information Favourable Opinion