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Colorectal Cancer Stage IIPhase 2NCT04486378

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 2 study testing RO7198457 intravenous (IV) in people with Colorectal Cancer Stage II and Colorectal Cancer Stage III, run by BioNTech SE at 85 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RO7198457 intravenous (IV)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
327 participants
Where
85 sitesin 7 countries
Study dates
8 Mar 2021to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • < 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

85 sites in 7 countries.

85 sites in 7 countries

Spain24 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital Nuestra Senora de Sonsoles

    Ávila, 05004

  • Hospital Universitari Germans Trias - ICO Badalona

    Badalona, 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

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

    Barcelona, 8036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

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

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

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

    Málaga, 29011

  • Complejo Hospitalario de Orense

    Ourense, 32005

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Complejo Hospitalario de Navarra (CHN)

    Pamplona, 31008

  • Hospital Universitario Marques De Valdecilla

    Santander, 39008

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocio - Hospital de la Mujer

    Seville, 41013

  • Consorcio Hospital General Valencia

    Valencia, 46014

  • Complexo Hospitalario Universitario de Vigo (CHUVI)

    Vigo, 36312

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany18 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitaetsklinikum St. Josef-Hospital Bochum

    Bochum, 44791

  • Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I

    Bonn, 53105

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

    Frankfurt am Main, 60488

  • Studiengesellschaft BSF

    Halle, 06108

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Hämatologisch-Onkologische Praxis Eppendorf

    Hamburg, 20249

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • National Center for Tumor Diseases (NCT) Heidelberg

    Heidelberg, 69120

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103

  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

    Mainz, 55131

  • LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München

    München, 81377

  • OhO Ostholstein Onkologie

    Oldenburg in Holstein, 23758

  • Prosper Hospital

    Recklinghausen, 45659

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

United Kingdom16 sites

  • 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

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

    Cottingham, HU16 5JQ

  • Dorset County Hospital NHS Foundation Trust - Dorset County Hospital

    Dorchester, DT1 2JY

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

    Glasgow, G12 0XH

  • St Bartholomew's Hospital-Barts Health NHS Trust

    London, EC1A 7BE

  • University College London Hospitals NHS Foundation Trust

    London, NW2 1PG

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

    London, SE1 7EH

  • The Royal Marsden NHS Foundation Trust- Chelsea

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

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

    Newcastle upon Tyne, NE7 7DN

  • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM25NG

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

    Torquay, TQ2 7AA

Other trials in United Kingdom

United States15 sites

  • Texas Oncology, P.A. - Austin

    Austin, Texas, 78705

  • Oncology Hematology Care Clinical Trials

    Cincinnati, Ohio, 45245

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Marin Cancer Care

    Greenbrae, California, 94904

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Comprehensive Cancer

    Indianapolis, Indiana, 46202

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Allina Health

    Minneapolis, Minnesota, 55407

  • Sarah Cannon (Tennessee Oncology - Nashville)

    Nashville, Tennessee, 37203

  • Rhode Island Hospital

    Providence, Rhode Island, 02906

  • Texas Oncology-San Antonio Medical Center

    San Antonio, Texas, 78240

  • University of Washington

    Seattle, Washington, 98109

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702

  • Northwest Cancer Specialists P.C.

    Vancouver, Washington, 98684

Other trials in United States

Belgium8 sites

  • Imeldaziekenhuis General Hospital

    Bonheiden, 2820

  • VZW Algemeen Ziekenhuis AZ Klina

    Brasschaat, 2930

  • GHDC (Grand Hopital de Charleroi)

    Charleroi, 6000

  • AZ Groeninge

    Kortrijk, 8500

  • Centres Hospitaliers Jolimont

    La Louvière, 7100

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

  • AZ Delta Roeselare

    Roeselare, 8800

  • GasthuisZusters Antwerpen - Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Canada2 sites

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8M2

  • Princess Margaret Cancer Centre

    Toronto, M5G 1X6

Other trials in Canada

Sweden2 sites

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

    Lund, 221 00

  • Sodersjukhuset, Onkologiska Kliniken

    Stockholm, 11883

Other trials in Sweden

About this study

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

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.

Read the detailed description

Patients will receive up to 15 doses of RO7198457 over the course of trial treatment.

Being tested
RO7198457 intravenous (IV), Observational group (no intervention)
Keywords
Cancer, Colorectal Cancer
Medical subject headings
Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7198457 intravenous (IV)Drug

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

  • Observational group (no intervention)Other

    watchful waiting

Study groups in NCT04486378
Study groupRoleWhat they receive
RO7198457ExperimentalParticipants will receive a recommended dose of RO7198457.
Receives: Drug: RO7198457 intravenous (IV)
Observational GroupOtherObservational group will undergo watchful waiting, which is the standard of care in this setting.
Receives: Other: Observational group (no intervention)
Biomarker CohortExperimentalNot described
Receives: Drug: RO7198457 intravenous (IV)
Exploratory CohortExperimentalNot described
Receives: Drug: RO7198457 intravenous (IV)
Colorectal Liver Metastasis (CLM) CohortExperimentalNot described
Receives: Drug: RO7198457 intravenous (IV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

    • Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.
    • Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment.
    • Death from any cause.
    • Loss to follow-up is censored.

    Measured: Through study completion, up to 5 years

Secondary outcomes (7)

  1. Relapse-free survival (RFS)

    RFS is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

    • Locoregional recurrence or distant metastases as determined by the investigator.
    • Death from any cause.
    • Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
    • Loss to follow-up is censored.

    Measured: Through study completion, up to 5 years

  2. Time to recurrence (TTR)

    TTR is defined as the time from randomization to occurrence of any of the following events (i.e., events related to the same cancer), whichever occurs first:

    • Locoregional recurrence or distant metastases as determined by the investigator.
    • Death from same cancer.
    • Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
    • Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored.

    Measured: Through study completion, up to 5 years

  3. Time to treatment failure (TTF)

    TTF is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

    • Locoregional recurrence or distant metastases as determined by the investigator.
    • Occurrence of second primary (same or other) cancer as determined by the investigator.
    • Death from any cause except non-cancer related death.
    • Start of new cancer therapy.
    • Loss to follow-up and non-cancer-related deaths are censored.

    Measured: Through study completion, up to 5 years

  4. Overall survival (OS)

    OS defined as the time from randomization to death from any cause.

    Measured: Through study completion, up to 5 years

  5. Change of ctDNA status (approximately every 3 months)

    Measured: Through study completion, up to 5 years

  6. Occurrence of treatment emergent adverse event (TEAE)

    TEAE, including Grade 3+, serious, fatal TEAE by relationship (adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0).

    Measured: 15 months

  7. Occurrence of dose reduction and discontinuation of RO7198457 due to a TEAE.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start8 Mar 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
327 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04486378
Sponsor's protocol ID
BNT122-01
Other IDs
2020-000451-12, U1111-1250-5294, 2023-509516-28-00, 2023
Status last verified
Oct 2026
First submitted
20 Jul 2020
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO7198457 intravenous (IV) in people with Colorectal Cancer Stage II and Colorectal Cancer Stage III, run by BioNTech SE at 85 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in Spain, Germany, United Kingdom, United States, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: Through study completion, up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04486378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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