CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9DW
Research type
Research Study
Full title
A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination with Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants with Advanced Hepatocellular Carcinoma
IRAS ID
272037
Contact name
Paul Ross
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-000252-34
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 7 months, 22 days
Research summary
This Phase 3 study aims to compare the overall survival (OS) of Nivolumab plus Ipilimumab versus the standard of care (SOC) treatment (Sorafenib or Lenvatinib) in all randomised participants with advanced Hepatocellular Carcinoma (HCC) who have not received prior systemic therapy. The main purpose of this study is to learn how well the investigational treatment works and how safe it is compared with other therapies that have already been FDA and EMA approved (standard of care treatments), in this case, sorafenib or lenvatinib. Participants will stop receiving study treatment 2 years after they receive their first study treatment. The study is divided into 3 time periods: a screening period, a treatment period, and a follow-up period. If the participants are eligible for the study, they will be randomly assigned to receive Investigational Therapy or Standard of Care.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1756
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion