CheckMate 648
Research type
Research Study
Full title
A Randomized Phase 3 Study of Nivolumab plus Ipilimumab or Nivolumab Combined with Fluorouracil plus Cisplatin versus Fluorouracil plus Cisplatin in Subjects with Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma
IRAS ID
216265
Contact name
Head of the Global Clinical Trial Submission Unit (GCT-SU)
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-001514-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 5 days
Research summary
This is a multicentre, phase 3 study of the investigational drug called Nivolumab, given alone or in combination with, another investigational drug called ipilimumab, or with chemotherapy, in patients with unresectable, advanced, recurrent or metastatic previously untreated oesophageal squamous cell carcinoma untreated cancer.
Nivolumab and Ipilimumab are a type of cancer drug designed to help the body’s immune system to recognise and attack cancer cells.
This study will assess if Nivolumab, given alone or with Ipilimumab or with chemotherapy, increases the survival of patients, who have a recurrent, inoperable, or metastatic oesophageal cancer, and delays the progression of their cancer.
1100 patients, aged 18 years or older, will take part globally in this study, 12 of them will be in the UK.
After a screening period, patients will have a treatment period and a follow-up period. During the treatment phase, patients will randomly receive one of the following treatments:
• Nivolumab every 2 weeks and Ipilimumab every 6 weeks
• Nivolumab every 2 weeks and chemotherapy (Fluorouracil plus Cisplatin) every 4 weeks
• Chemotherapy (Fluorouracil plus Cisplatin)every 4 weeks
Patients will receive the drugs into a vein. Both the patients and the study doctor will know which treatment patients will receive.
During their study participation, patients will have physical examinations (including vital signs and weight), scans, biopsies (if needed), ECGs and blood samples for safety and for study-specific tests, Patients will receive the drugs until, they withdraw their consent to receive the study drugs, or they no longer tolerate the study treatment or their cancer progresses.
The study is paid by Bristol-Myers Squibb (BMS).REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1273
Date of REC Opinion
30 Aug 2017
REC opinion
Further Information Favourable Opinion