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BioNTech clinical trials patient information +49 6131 9084
patients@biontech.de


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Be Part of Research - Trial Details - A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

Medical Conditions

Colorectal Neoplasms


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2021 Feb 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.

Intervention Arm Group : Biomarker Cohort;Exploratory Cohort;RO7198457;

Intervention Type : OTHER
Intervention Description : watchful waiting

Intervention Arm Group : Observational Group;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guy's and St Thomas' Hospital NHS Foundation Trust
    London
    SE1 7EH
  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Bebington
    CH63 4JY
  • Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust
    Birmingham
    B15 2GW
  • Velindre NHS Trust, Velindre Cancer Centre
    Cardiff
    CF14 2TL
  • St Bartholomew's Hospital-Barts Health NHS Trust
    London
    EC1A 7BE
  • University College London Hospitals NHS Foundation Trust
    London
    NW2 1PG
  • The Royal Marsden NHS Foundation Trust- Chelsea
    London
    SW3 6JJ
  • The Royal Marsden NHS Foundation Trust
    Sutton
    SM25NG
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
    Newcastle Upon Tyne
    NE7 7DN
  • Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge
    Torquay
    TQ2 7AA
  • Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and Clyde
    Glasgow
    G12 0XH
  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
    Preston
    PR2 9HT
  • Royal Free London NHS Foundation Trust
    London
    NW3 2QG
  • The Christie NHS Foundation Trust
    Manchester
    M20 4BX

BioNTech clinical trials patient information +49 6131 9084
patients@biontech.de



The study is sponsored by BioNTech SE and funded by Genentech, Inc..




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Read full details for Trial ID: NCT04486378
Last updated 05 June 2024

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