BNT122-01 RO7198457 vs watchful waiting in colorectal cancer
Research type
Research Study
Full title
A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection
IRAS ID
1005451
Contact name
Neslihan Orhon
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2020-000451-12
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn about the effects of an experimental treatment called RO7198457 in High Risk Stage II or III colon or rectal cancer ('colorectal') patients following resection. Participants will be randomly assigned either to an experimental group to receive the study treatment RO7198457, or to an observational group with no experimental treatment but ‘watchful waiting’ (the standard care for people that have already had surgery and chemotherapy for their colorectal cancer).
The research study involves the development and testing of an individualised cancer treatment called RO7198457. Individualised means that it is manufactured individually for each participant, according to their unique cancer. The goal of an individualised cancer treatment approach is to help train the immune system to recognise and attack cancer cells.
DNA in the participant’s blood and tumour sample will be compared. From this comparison, we can identify changes (mutations) that originate from the tumour. These mutations create a unique “fingerprint”. These mutations can therefore be detected and monitored in the blood. Testing for ctDNA is a mandatory part of this study.
Participant’s immune systems can recognise some parts of these mutations (neoantigens). A neoantigen is a protein that forms on the cell surface of the cancer cells when certain mutations occur in the tumour DNA.
Using a computerised system, between 5 & 20 different neoantigens from the participant’s tumour will be selected & used to make RO7198457. These tumour neoantigens are those that will most likely activate immune cells to recognize & attack cancer cells.
Participants randomised to receive the study treatment will receive 15 treatments of RO7198457 over one year, and be followed up for at least 36 months. Participants who are randomised to the observation group will be followed up for at least 48 months and visit the research site every 3 months.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0621
Date of REC Opinion
25 Oct 2022
REC opinion
Further Information Favourable Opinion