Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy

Active, not recruiting

• Conditions: Colorectal Cancer Stage II; Colorectal Cancer Stage III
• Interventions: Procedure: Regular blood sample collection for ctDNA assessment

• Registration Number: NCT04813627
• Lead Sponsor: BioNTech SE

Brief Summary

This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of up to 630 days (21 months) thereafter, according to CRC stages and disease characteristics.

Participants receive no therapeutic intervention as part of this study. This study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection who might be potential candidates for the clinical study BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard adjuvant chemotherapy in this patient population. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that study if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from this study (BNT000-001) will be carried across to the BNT122-01 study where feasible.

Detailed Description

Individual participants will be involved in the study for at least 12 months to up to 29 months (maximum follow-up 21 months after completion of AdCTx \[Visit 10\]). For all participants who transfer to BNT122-01 (NCT04486378), study participation in BNT000-001 will end at time of screening for BNT122-01.

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-07-02
• Status Verified: 2025-04
• Primary Completion: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• Must have given informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

• Age ≥ 18 years old at time of signing the informed consent form.

• Ability to comply with the study protocol, in the investigator's judgment.

• 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 (any of):

  • T4
  • Grade ≥ 3
  • Clinical presentation with bowel obstruction or perforation
  • Histological signs of vascular, lymphatic or perineural invasion
  • < 12 nodes examined

• Adequate tumor material in formalin-fixed paraffin embedded blocks or as sectioned tissue (only upon approval by sponsor) must be available, preferably from resection. The specimen should be submitted along with an associated pathology report. Multiple samples may be provided as available, but priority should be given to tissue with the highest tumor content and lowest necrotic area.

• Intention to receive a standard of care AdCTx within 8 weeks post-surgery, and be scheduled for at least 3 months of treatment (including rest days) according to the treating physician or investigator.

• Eastern Cooperative Oncology Group Performance Status of 0 or 1.

• Adequate end-organ function.

Exclusion Criteria

• Neo-adjuvant (radio)chemotherapy prior to surgery.

• Prior systemic investigational therapy.

• Active Hepatitis B virus (HBV) infection.

• Active hepatitis C virus (HCV) infection.

• History of human immunodeficiency virus (HIV) antibody positivity.

• Residual tumor classification following surgery other than R0 (microscopic margin-negative resection).

• Participants 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.

• Participant has not started standard of care AdCTx within 8 weeks post-surgery.

• Participant has received less than 3 months (including rest days) of AdCTx treatment.

• Inadequate tumor material (either quality or quantity) to support ctDNA analysis.

• Participants who have had prior splenectomy.

• Participants with diagnosed microsatellite instability high tumors.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with R0 resected Stage II (high risk) or Stage III CRC	Regular blood sample collection for ctDNA assessment	The participants eligible for this epidemiological study are those with completely resected Stage II (high risk)/III CRC (per the American Joint Committee on Cancer (AJCC) 8th revised edition staging system) due to receive standard of care chemotherapy for at least 3 months following surgery.

Primary Outcome Measures

Name	Time	Method
Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample	4 to 8 weeks (28 to 56 days) after surgery and within 7 days prior to start of AdCTx	Blood sample taken post-surgery and pre-adjuvant chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Transfer of participants from the BNT000-001 study to the BNT122-01 clinical trial	4 weeks following Visit 1 (upon availability of ctDNA positivity status)	The absolute and relative frequency of participants that will transfer to the BNT122-01 clinical trial from this epidemiological study will be reported.

Trial Locations

Locations (74)

Centrum fuer Haematologie und Onkologie Bethanien; 🇩🇪 Frankfurt am Main, Germany

Agaplesion Markus Krankenhaus; 🇩🇪 Frankfurt am Main, Germany

Medizinische Klinik III, Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Cancer Center Donauwoerth and Dachau; 🇩🇪 Donauwoerth, Germany

St. Johannes Hospital; 🇩🇪 Dortmund, Germany

Asklepios MVZ Elmshorn; 🇩🇪 Elmshorn, Germany

Complejo Hospitalario de Orense; 🇪🇸 Orense, Spain

Corporacio Sanitaria Universitaria Parc Tauli; 🇪🇸 Sabadell, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Ridley-Tree Cancer Center; 🇺🇸 California City, California, United States

John Muir Clinical Research Center; 🇺🇸 Concord, California, United States

Marin Cancer Care; 🇺🇸 Greenbrae, California, United States

The Oncology Institute of Hope; 🇺🇸 Los Angeles, California, United States

Rocky Mountain Cancer Centers - Denver Midtown; 🇺🇸 Denver, Colorado, United States

Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur; 🇺🇸 Decatur, Illinois, United States

Orchard Healthcare Research Inc.; 🇺🇸 Skokie, Illinois, United States

USOR - New York Oncology Hematology, P.C.; 🇺🇸 Albany, New York, United States

Oncology Hematology Care Clinical Trials, LLC; 🇺🇸 Cincinnati, Ohio, United States

USOR - Willamette Valley Cancer Institute and Research Center; 🇺🇸 Eugene, Oregon, United States

Texas Oncology - Austin; 🇺🇸 Austin, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Texas Oncology - San Antonio Medical Center; 🇺🇸 San Antonio, Texas, United States

Texas Oncology - Northeast Texas; 🇺🇸 Tyler, Texas, United States

Virginia Cancer Specialists, PC; 🇺🇸 Fairfax, Virginia, United States

Rockwood Cancer Treatment Center; 🇺🇸 Spokane, Washington, United States

Northwest Cancer Specialists; 🇺🇸 Vancouver, Washington, United States

ZNA Campus Middelheim; 🇧🇪 Antwerpen, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

VZW Algemeen Ziekenhuis KLINA; 🇧🇪 Brasschaat, Belgium

Algemeen Ziekenhuis Sint-Lucas; 🇧🇪 Brugge, Belgium

Universitair Ziekenhuis Brussel (UZ-VUB - Academisch Ziekenhuis); 🇧🇪 Jette, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

Centres Hospitaliers Jolimont; 🇧🇪 La Louvière, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Clinique et Maternite Sainte-Elisabeth (CMSE); 🇧🇪 Namur, Belgium

Clinique Saint-Pierre d'ottignies (CSPO); 🇧🇪 Ottignies, Belgium

Algemeen Ziekenhuis (AZ) Glorieux; 🇧🇪 Ronse, Belgium

Centre Hospitalier Regional, CHR; 🇧🇪 Verviers, Belgium

Gemeinschaftspraxis Dr. med. B. Heinrich, Prof. M. Bangerter MD; 🇩🇪 Augsburg, Germany

Charité Campus Mitte (CCM) - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitaetsklinikum St. Josef-Hospital Bochum; 🇩🇪 Bochum, Germany

Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung; 🇩🇪 Frankfurt am Main, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Studiengesellschaft BSF; 🇩🇪 Halle, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Haematologisch-Onkologische Praxis Eppendorf HOPE; 🇩🇪 Hamburg, Germany

Asklepios Kliniken Nord; 🇩🇪 Hamburg, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

SLK-Kliniken Heilbronn GmbH; 🇩🇪 Heilbronn, Germany

Staedtisches Krankenhaus Kiel gGmbH; 🇩🇪 Kiel, Germany

Internistische Schwerpunktpraxis Hamatologie und Onkologie; 🇩🇪 Mainz, Germany

Ze:ro Arztpraxen; 🇩🇪 Mannheim, Germany

Klinikum der Universität München, Medizinische Klinik und Poliklinik III; 🇩🇪 München, Germany

Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach; 🇩🇪 München, Germany

Prosper Hospital; 🇩🇪 Recklinghausen, Germany

Universitaetsmedizin Rostock; 🇩🇪 Rostock, Germany

Universitaetsklinikum Ulm; 🇩🇪 Ulm, Germany

Asklepios Klinik Weissenfels; 🇩🇪 Weißenfels, Germany

Helios Dr. Horst Schmidt Kliniken (HSK); 🇩🇪 Wiesbaden, Germany

Forschungszentrum Ruhr; 🇩🇪 Witten, Germany

Complejo Hospitalario Universitario A Coruna; 🇪🇸 A Coruña, Spain

Centro Oncologico Galicia; 🇪🇸 A Coruña, Spain

Hospital Universitari Germans Trias - ICO Badalona; 🇪🇸 Badalona, Spain

IOR- Instituto Quiron Dexeus; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital De Sant Joan Despi Moises Broggi; 🇪🇸 Barcelona, Spain

Hospital General De Granollers; 🇪🇸 Granollers, Spain

Hospital Sant Joan de Deu-Fundacio Althaia; 🇪🇸 Manresa, Spain

Complejo Hospitalario Universitario De Santiago De Compostela; 🇪🇸 Santiago De Compostela, Spain

Hospital Universitario Mutua de Terrassa; 🇪🇸 Terrassa, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitari Sant Joan de Reus; 🇪🇸 Reus, Spain