Clinical trials /

BioNTech Vaccine

Active, not recruitingPhase 2InterventionalNCT04486378 ↗

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 or colon. The study will test whether the vaccine can reduce recurrence of the c

Sponsor
BioNTech SE
Planned enrollment
327 participants
Start date
March 8, 2021
Primary completion
November 2026 (est.)
Minimum age
18 Years
Interventions
RO7198457 intravenous (IV), Observational group (no intervention)

Official 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

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

This study is designed for patients who have recently undergone resection of their colon cancer and identified a high risk stage II or stage III cancer.  ctDNA testing is done in the context of the trial with a Roche Molecular ctDNA assay.

Treatment Regimens

Upon completion of standard adjuvant therapy, patients are randomized to RO7198457 intravenous (i.v.) or observation.  This is an open label study (patients are notified of the arm they are randomized into)

RO7198457 administered as an IV infusion at protocol-specified intervals over 12 months

Key Eligibility Criteria

  • Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as Stage II disease with any of the following risk factors for recurrence:
    • T4
    • Grade ≥ 3.
    • Clinical presentation with bowel obstruction or perforation.
    • Histological signs of vascular, lymphatic or perineural invasion.
    • < 12 nodes examined.
  • Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx)• ctDNA assay must be performed through this study or study BNT000-001 ctDNA screening protocol.

See ClinicalTrials.gov for more details:

Study Record

Sign up to be notified of new trials and Updates in the field:

Register Now

Thank you for signing up for updates. Your email has been registered.

×

There was an error trying to register your email. Please try again later.

×

Where this trial is offered

  • Marin Cancer CareGreenbrae, California
  • Indiana University Melvin and Bren Simon Comprehensive CancerIndianapolis, Indiana
  • Allina HealthMinneapolis, Minnesota
  • Oncology Hematology Care Clinical TrialsCincinnati, Ohio
  • Rhode Island HospitalProvidence, Rhode Island
  • Sarah Cannon (Tennessee Oncology - Nashville)Nashville, Tennessee
  • Texas Oncology, P.A. - AustinAustin, Texas
  • Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallas, Texas
  • The University of Texas MD Anderson Cancer CenterHouston, Texas
  • Texas Oncology-San Antonio Medical CenterSan Antonio, Texas
  • Texas Oncology - Northeast TexasTyler, Texas
  • Virginia Cancer SpecialistsFairfax, Virginia
  • University of WashingtonSeattle, Washington
  • Northwest Cancer Specialists P.C.Vancouver, Washington
  • University of Wisconsin Carbone Cancer CenterMadison, Wisconsin
  • Imeldaziekenhuis General HospitalBonheiden, Belgium
  • VZW Algemeen Ziekenhuis AZ KlinaBrasschaat, Belgium
  • GHDC (Grand Hopital de Charleroi)Charleroi, Belgium
  • AZ GroeningeKortrijk, Belgium
  • Centres Hospitaliers JolimontLa Louvière, Belgium
  • Universitaire Ziekenhuizen LeuvenLeuven, Belgium
  • AZ Delta RoeselareRoeselare, Belgium
  • GasthuisZusters Antwerpen - Sint-AugustinusWilrijk, Belgium
  • The Ottawa Hospital Cancer CentreOttawa, Canada
  • Princess Margaret Cancer CentreToronto, Canada
  • Charité - Universitätsmedizin BerlinBerlin, Germany
  • Universitaetsklinikum St. Josef-Hospital BochumBochum, Germany
  • Universitätsklinikum Bonn, Med. Klinik u. Poliklinik IBonn, Germany
  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)Frankfurt am Main, Germany
  • Studiengesellschaft BSFHalle, Germany
  • Universitätsklinikum Hamburg-EppendorfHamburg, Germany
  • Hämatologisch-Onkologische Praxis EppendorfHamburg, Germany
  • Asklepios Klinik AltonaHamburg, Germany
  • Medizinische Hochschule HannoverHanover, Germany
  • National Center for Tumor Diseases (NCT) HeidelbergHeidelberg, Germany
  • SLK-Kliniken Heilbronn GmbHHeilbronn, Germany
  • Universitaetsklinikum Leipzig AoeRLeipzig, Germany
  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeRMainz, Germany
  • LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität MünchenMünchen, Germany
  • OhO Ostholstein OnkologieOldenburg in Holstein, Germany
  • Prosper HospitalRecklinghausen, Germany
  • Universitätsklinikum UlmUlm, Germany
  • Universitätsklinikum WürzburgWürzburg, Germany
  • Complejo Hospitalario Universitario A CorunaA Coruña, Spain
  • Hospital Nuestra Senora de SonsolesÁvila, Spain
  • Hospital Universitari Germans Trias - ICO BadalonaBadalona, Spain
  • Hospital Universitari Vall d'HebronBarcelona, Spain
  • Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de BarcelonaBarcelona, Spain
  • Hospital de la Santa Creu i Sant PauBarcelona, Spain
  • Hospital Universitario Reina SofiaCórdoba, Spain
  • Hospital General Universitario Gregorio MaranonMadrid, Spain
  • Hospital Universitario Ramón y CajalMadrid, Spain
  • Hospital Clinico San CarlosMadrid, Spain
  • Hospital Universitario Fundacion Jimenez DiazMadrid, Spain
  • Hospital Universitario La PazMadrid, Spain
  • Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)Madrid, Spain
  • Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, Spain
  • Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de MalagaMálaga, Spain
  • Complejo Hospitalario de OrenseOurense, Spain
  • Clinica Universitaria de NavarraPamplona, Spain
  • Complejo Hospitalario de Navarra (CHN)Pamplona, Spain
  • Hospital Universitario Marques De ValdecillaSantander, Spain
  • Complejo Hospitalario Universitario De Santiago De CompostelaSantiago de Compostela, Spain
  • Hospital Universitario Virgen del Rocio - Hospital de la MujerSeville, Spain
  • Consorcio Hospital General ValenciaValencia, Spain
  • Complexo Hospitalario Universitario de Vigo (CHUVI)Vigo, Spain
  • Hospital Universitario Miguel ServetZaragoza, Spain
  • Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)Lund, Sweden
  • Sodersjukhuset, Onkologiska KlinikenStockholm, Sweden
  • The Clatterbridge Cancer Centre NHS Foundation TrustBebington, United Kingdom
  • Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation TrustBirmingham, United Kingdom
  • Velindre NHS Trust, Velindre Cancer CentreCardiff, United Kingdom
  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill HospitalCottingham, United Kingdom
  • Dorset County Hospital NHS Foundation Trust - Dorset County HospitalDorchester, United Kingdom
  • Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and ClydeGlasgow, United Kingdom
  • St Bartholomew's Hospital-Barts Health NHS TrustLondon, United Kingdom
  • University College London Hospitals NHS Foundation TrustLondon, United Kingdom
  • Guy's and St Thomas' Hospital NHS Foundation TrustLondon, United Kingdom
  • The Royal Marsden NHS Foundation Trust- ChelseaLondon, United Kingdom
  • The Christie NHS Foundation TrustManchester, United Kingdom
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman HospitalNewcastle upon Tyne, United Kingdom
  • Churchill Hospital - Oxford University Hospitals NHS Foundation TrustOxford, United Kingdom
  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation TrustPreston, United Kingdom
  • The Royal Marsden NHS Foundation TrustSutton, United Kingdom
  • Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes BridgeTorquay, United Kingdom

Status, sites, and study facts from ClinicalTrials.gov, last posted August 28, 2026 and refreshed here September 5, 2026.View the full record for NCT04486378.