RO7198457 in combination with Pembrolizumab or Pembrolizumab alone
Research type
Research Study
Full title
A Phase II, Open-label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination with Pembrolizumab Versus Pembrolizumab in Patients with Previously Untreated Advanced Melanoma.
IRAS ID
266000
Contact name
Eric Olson
Contact email
Sponsor organisation
Genentech Inc.
Eudract number
2018-001773-24
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 2 months, 27 days
Research summary
This study will test the safety and efficacy of a drug called RO7198457 (which is a personalised cancer vaccine). RO7198457 will be tested in combination with an approved standard of care (Pembrolizumab) versus Pembrolizumab alone, in patients with previously untreated advanced melanoma. The treatment is a type of immunotherapy, whereby samples of tumour tissue and blood will be collected from participants and tested, to see if RO7198457 can be made for them.
The goal of RO7198457 is to help train the immune system to recognise and attack cancer cells. Because the immune system has memory, it is hoped that once the immune cells have been trained, they will continue to work for a long time after the RO7198457 is given.
The study will be conducted globally and will enrol male and female patients with unresectable locally advanced and metastatic melanoma. About 132 people will participate in the study.
The study consists of an initial safety run-in stage and a randomised stage. Each stage will have a two-part screening period, a treatment period, and post-treatment follow-up period.
Eligible patients will be randomly assigned to receive either RO7198457 plus pembrolizumab or pembrolizumab alone.
A number of assessments and procedures may be performed during the study including physical examinations, blood sample tests, radiological assessments (CT/MRI and/or PET), heart function assessment (electrocardiograms), and completion of quality of life questionnaires. These assessments are performed as part of the evaluation to determine if the study drug is effective and safe. The study is sponsored by Genentech, Inc.REC name
North East - York Research Ethics Committee
REC reference
19/NE/0291
Date of REC Opinion
5 Dec 2019
REC opinion
Further Information Favourable Opinion