MORPHEUS-NEO HCC
Research type
Research Study
Full title
A Phase IB/II, Open-Label, Multicenter, Randomized Platform Study Evaluating the Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients with Surgically Resectable Hepatocellular Carcinoma (Morpheus-Neo HCC)
IRAS ID
1007674
Contact name
Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd.
Research summary
The purpose of this research study is to compare the effects of different cancer immunotherapy (CIT) based treatment combinations in patients with early liver cancer (also known as hepatocellular carcinoma [HCC]), to find out which is better. Participants whose cancer can be removed with surgery and have not received prior treatment given close to or directly into the tumour, may be eligible to take part.
After a Screening period to determine whether participants are eligible for the study, participants will be assigned to receive one of several CIT combinations (consisting of at least one CIT drug). The study is designed with the flexibility to open new treatment groups as new agents become available, close existing treatment groups that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.
Approximately 90-150 participants will be enrolled during the study, with approx. 30-50 participants enrolled into each treatment group. The total duration of study participation for each individual is expected to range from 1 day to approx. 2 to 3 years.
A number of assessments will be performed including physical examinations, vitals signs, collection of blood, urine and tumour tissue samples, electrocardiograms, Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and/or bone scans. The study is sponsored by F. Hoffmann-La Roche Ltd.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0136
Date of REC Opinion
4 Oct 2023
REC opinion
Further Information Favourable Opinion