CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 577
Research type
Research Study
Full title
A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer
IRAS ID
202286
Contact name
Head Of Global Clinical Trial Submissions Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2015-005556-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CANC 5379, NIHR CRN Ref Number
Duration of Study in the UK
4 years, 0 months, 31 days
Research summary
This is a phase III study of Nivolumab versus Placebo in patients with resected oesophageal or gastroesophageal junction cancer.
The purpose of the study is to compare overall survival and disease-free survival of patients who have stage II or III oesophageal or gastroesophageal junction cancer, have undergone chemotherapy plus radiation therapy, followed by surgery to remove their whole tumour. At present, there is no standard of care (SOC) for such patients beyond being followed-up after their surgery for disease return. The study will evaluate the probability of disease return in patients who receive nivolumab versus patients receiving placebo after surgical resection and will compare the survival of the two patient groups.
Globally, approximately 760 patients will be randomised to receive either nivolumab or placebo, with approximately 15 of them in the UK. The study is sponsored by Bristol-Myers Squibb (BMS).
Following a screening period, two thirds of the eligible patients will receive nivolumab (the drug under investigation) and one third will receive placebo (dummy drug – no active substance). All patients will receive nivolumab or placebo for up to 12 months or until disease recurrence, whichever comes first. The first 8 infusions will be done every 2 weeks, followed by infusions every 4 weeks. After the treatment phase, patients will be followed for survival for up to 5 years, over the phone or through hospital visits.
Patients will undergo CT scan, physical exams, vital signs such as blood pressure, height, weight, body temperature, blood samples for routine safety testing and study specific testing. Patients will also be required to complete questionnaires regularly throughout the study. Additional biopsies may be performed or previous biopsies obtained if available and if patients consent.REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0985
Date of REC Opinion
1 Aug 2016
REC opinion
Further Information Favourable Opinion