Phase III Open-Label Esophageal Cancer - ONO-4538
Research type
Research Study
Full title
A Multicenter, Randomized, Open-label Study in Patients with esophageal Cancer refractory or intolerant to Combination Therapy with Fluoropyrimidine and Platinum-based Drugs
IRAS ID
200037
Contact name
Jeff Evans
Contact email
Sponsor organisation
Ono Pharmaceutical Co., Ltd.
Eudract number
2015-003339-36
Duration of Study in the UK
2 years, 11 months, 25 days
Research summary
This is a phase III study for oesophageal cancer patients. The purpose of this study is to test the effectiveness (how well the drug works), safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558 and ONO-4538) and also to see if nivolumab can be more safe and effective than docetaxel or paclitaxel (the standard chemotherapy medications for this type of cancer). The study is randomised (patients will be assigned one of two treatment groups), multicentre and open label (the patient and doctor will know the assigned treatment arm).
The study is split into three sections, screening – to check for eligibility, treatment and follow up. If a patient is deemed eligible according to the screening criteria they will be randomised to the standard treatment (docetaxel or paclitaxel) arm or the nivolumab arm. During the treatment phase, patients will be expected to attend clinic every two weeks if they are on the nivolumab arm, every 3 weeks if they are on the docetaxel arm and every week for 6 weeks followed by a 2 week break if they are on the paclitaxel arm. Patients will continue to receive treatment until their condition worsens or the side effects become intolerable. When a patient is removed from the study they will undergo safety assessments and will be followed up for disease assessment.
The study will take place at 7 NHS hospital sites in the UK and 10 patients are expected to be recruited. A total of 390 patients will take part worldwide.
Tests undertaken will include but are not limited to; physical exam, vital signs, height, weight, pregnancy test, chest x-ray (if required), electrocardiogram, blood tests, CT scan/MRI/FDG-PET/Bone Scan.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0293
Date of REC Opinion
21 Jul 2016
REC opinion
Further Information Favourable Opinion