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New vaccine aims to stop colorectal cancer recurrence in High-Risk patients

NCT ID NCT04486378

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study tests an experimental vaccine (RO7198457) in people with stage II or III colorectal cancer who have signs of remaining cancer DNA in their blood after surgery. The goal is to see if the vaccine can prevent the cancer from returning better than simply watching and waiting. About 327 participants will be randomly assigned to receive the vaccine or no immediate treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 327 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must be a man or woman of at least 18 years of age. * Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per American Joint Committee on Cancer (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 evaluated after surgery. * For the CLM Cohort: patients must have metastatic colorectal cancer (mCRC) (Stage IV) with resected CLM (synchronous and metachronous CLM within 6 months of initial diagnosis) per AJCC 2017, after standard of care (SoC) primary resection and curative-intent hepatectomy (R0 confirmed by pathology report) with or without (neo-)adjuvant chemotherapy (prior to hepatectomy), and planned adjuvant chemotherapy. * For the Biomarker Cohort: patients with tumors of the colon, including but not limited to, colon adenocarcinoma, carcinoid tumors (including goblet cell carcinoid/adenocarcinoma), and tumors of the appendix, whose tumors were surgically resected and are planned for adjuvant chemotherapy (per institutional standards), can be included. * Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx) (except for the Biomarker Cohort). * ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening protocol. * Patients must have an Eastern Cooperative Oncology Group Performance Status of 0-1. * Patients must have adequate hematologic, bone marrow and organ function as defined by the protocol. * Adequate tumor material in formalin-fixed paraffin embedded blocks or as sectioned tissue (only upon approval by sponsor) must be available (as described in the laboratory manual). For the CLM Cohort: tumor material must come from primary resection for patients who undergo staged approach, or from available archival material from the previously untreated tumor biopsy from the primary. * At least 5 tumor neoantigens identified in the provided tumor sample. * The patient has started a standard of care AdCTx preferably within 8 weeks but no later than 10 weeks post-surgery and has completed at least 3 months of treatment of a 3- or a 6-month course of chemotherapy (including rest days). For the CLM Cohort: patient must have completed AdCTx with or without (neo-)adjuvant chemotherapy for up to 6 months in total or total intended amount determined by care providers per SoC. AdCTx must have started preferably within 8 weeks, but no later than 10 weeks, after hepatectomy. For the Biomarker Cohort: patient must have received at least one cycle of adjuvant chemotherapy per institutional standards. Exclusion Criteria: * Patients with uncontrolled intercurrent illness as defined by the protocol. * Diagnosed microsatellite instability high tumors. * Prior therapy with any of the following: * Neo-adjuvant (radio)chemotherapy prior to surgery. * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of trial treatment or anticipation of need for systemic immunosuppressive medication during trial treatment, with the exception of low dose steroids defined as 10 mg oral prednisone (or equivalent). * Current or recent (within the 28 days prior to randomization) treatment with another investigational drug. * Exception for the CLM Cohort: primary tumor must be resected and (neo-)adjuvant chemotherapy prior to curative-intent hepatectomy is accepted. * Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy. * Patients who developed metastatic disease during screening/receiving standard of care treatment (not applicable for the Exploratory Cohort or the Biomarker Cohort). * Patients with known past or current malignancy other than inclusion diagnosis, except for: * Cervical carcinoma of Stage 1B or less. * Non-invasive basal cell or squamous cell skin carcinoma. * Non-invasive, superficial bladder cancer. * Prostate cancer with a current prostate-specific antigen level \< 0.1 ng/mL. * Any curable cancer with a complete response of \> 2 years duration. * Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its excipients. * Patients who had major surgery (e.g., surgery requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or have surgery planned during the time the patient are expected to participate in the trial. * Patients with positive serology for hepatitis B indicative of active hepatitis B infection: * Positive test for hepatitis B surface antigen (HBsAg) OR * Negative test for HBsAg AND positive test for antibodies to hepatitis B core antigens (anti-HBc) AND positive test for hepatitis B virus (HBV) DNA. * Serological markers indicative of vaccination (isolated antibodies to hepatitis B surface antigens \[anti-HBs\]) or resolved natural infection without viral load (anti-HBc with negative HBsAg and negative HBV DNA) are not exclusionary. * Active Hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed. * Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening. * Patients who have had prior splenectomy. NOTE: Other protocol defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

appendiceal neoplasm carcinoid tumor colon adenocarcinoma colorectal cancer colorectal carcinoma colorectal neoplasm goblet cell carcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer stage II Colorectal cancer stage III

Contacts and locations

Locations

  • AZ Delta Roeselare

    Roeselare, 8800, Belgium

  • AZ Groeninge

    Kortrijk, 8500, Belgium

  • Allina Health

    Minneapolis, Minnesota, 55407, United States

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and Clyde

    Glasgow, G12 0XH, United Kingdom

  • Centres Hospitaliers Jolimont

    La Louvière, 7100, Belgium

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Clinica Universitaria de Navarra

    Pamplona, 31008, Spain

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706, Spain

  • Complejo Hospitalario de Navarra (CHN)

    Pamplona, 31008, Spain

  • Complejo Hospitalario de Orense

    Ourense, 32005, Spain

  • Complexo Hospitalario Universitario de Vigo (CHUVI)

    Vigo, 36312, Spain

  • Consorcio Hospital General Valencia

    Valencia, 46014, Spain

  • Dorset County Hospital NHS Foundation Trust - Dorset County Hospital

    Dorchester, DT1 2JY, United Kingdom

  • GHDC (Grand Hopital de Charleroi)

    Charleroi, 6000, Belgium

  • GasthuisZusters Antwerpen - Sint-Augustinus

    Wilrijk, 2610, Belgium

  • Guy's and St Thomas' Hospital NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Nuestra Senora de Sonsoles

    Ávila, 05004, Spain

  • Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga

    Málaga, 29011, Spain

  • Hospital Universitari Germans Trias - ICO Badalona

    Badalona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)

    Madrid, 28050, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques De Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen del Rocio - Hospital de la Mujer

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

    Cottingham, HU16 5JQ, United Kingdom

  • Hämatologisch-Onkologische Praxis Eppendorf

    Hamburg, 20249, Germany

  • Imeldaziekenhuis General Hospital

    Bonheiden, 2820, Belgium

  • Indiana University Melvin and Bren Simon Comprehensive Cancer

    Indianapolis, Indiana, 46202, United States

  • Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona

    Barcelona, 8036, Spain

  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)

    Frankfurt am Main, 60488, Germany

  • LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München

    München, 81377, Germany

  • Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)

    Lund, 221 00, Sweden

  • Marin Cancer Care

    Greenbrae, California, 94904, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • National Center for Tumor Diseases (NCT) Heidelberg

    Heidelberg, 69120, Germany

  • Northwest Cancer Specialists P.C.

    Vancouver, Washington, 98684, United States

  • OhO Ostholstein Onkologie

    Oldenburg in Holstein, 23758, Germany

  • Oncology Hematology Care Clinical Trials

    Cincinnati, Ohio, 45245, United States

  • Princess Margaret Cancer Centre

    Toronto, M5G 1X6, Canada

  • Prosper Hospital

    Recklinghausen, 45659, Germany

  • Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW, United Kingdom

  • Rhode Island Hospital

    Providence, Rhode Island, 02906, United States

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT, United Kingdom

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078, Germany

  • Sarah Cannon (Tennessee Oncology - Nashville)

    Nashville, Tennessee, 37203, United States

  • Sodersjukhuset, Onkologiska Kliniken

    Stockholm, 11883, Sweden

  • St Bartholomew's Hospital-Barts Health NHS Trust

    London, EC1A 7BE, United Kingdom

  • Studiengesellschaft BSF

    Halle, 06108, Germany

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702, United States

  • Texas Oncology, P.A. - Austin

    Austin, Texas, 78705, United States

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology-San Antonio Medical Center

    San Antonio, Texas, 78240, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, CH63 4JY, United Kingdom

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8M2, Canada

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM25NG, United Kingdom

  • The Royal Marsden NHS Foundation Trust- Chelsea

    London, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge

    Torquay, TQ2 7AA, United Kingdom

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103, Germany

  • Universitaetsklinikum St. Josef-Hospital Bochum

    Bochum, 44791, Germany

  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

    Mainz, 55131, Germany

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000, Belgium

  • University College London Hospitals NHS Foundation Trust

    London, NW2 1PG, United Kingdom

  • University of Washington

    Seattle, Washington, 98109, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I

    Bonn, 53105, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • VZW Algemeen Ziekenhuis AZ Klina

    Brasschaat, 2930, Belgium

  • Velindre NHS Trust, Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

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