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

Colorectal Cancer Stage III Clinical Trial

Official title:

Epidemiological Study to Determine the Prevalence of ctDNA Positivity in Participants With Stage II (High Risk) or Stage III CRC After Surgery With Curative (R0) Intent and Subsequent Adjuvant Chemotherapy With Monitoring of ctDNA During Clinical Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813627
• Other study ID #: BNT000-001
• Status: Recruiting
• Start date: July 2, 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: BioNTech SE
• Contact: BioNTech clinical trials patient information
• Phone: +49 6131 9084
• Email: patients[@]biontech.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 630 days thereafter, according to CRC stages and disease characteristics.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (FFPE) 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 adjuvant chemotherapy (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 (ECOG) Performance Status of 0 or 1.

• Adequate end-organ function.

Exclusion Criteria:

• Induction of neoadjuvant systemic therapy prior to resection of CRC.

• Prior systemic investigational therapy.

• Positive serology for hepatitis B (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy):

• Positive test for antibodies to hepatitis B core antigens (anti HBc) and

• Negative test for antibodies to hepatitis B surface antigens (anti HBs).

• Active hepatitis C virus (HCV) infection; participants who have completed curative antiviral treatment with HCV viral load below the limit of quantification by polymerase chain reaction (PCR) are allowed.

• Participant has a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.

• 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 PSA level < 0.1 ng/mL.

• Any curable cancer with a complete response (CR) 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 circulating tumor DNA (ctDNA) analysis.

• Participants who have had prior splenectomy.

Related Conditions & MeSH terms

• Colorectal Cancer Stage II
• Colorectal Cancer Stage III
• Colorectal Neoplasms

Intervention

Procedure:
• Regular blood sample collection for ctDNA assessment
Blood samples for in vitro testing of ctDNA status will be drawn at study visits every three months

Locations

Country	Name	City	State
Belgium	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
Germany	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	Medizinische Klinik III, Universitätsklinikum Bonn	Bonn
Germany	Cancer Center Donauwoerth and Dachau	Donauwoerth
Germany	St. Johannes Hospital	Dortmund
Germany	Asklepios MVZ Elmshorn	Elmshorn
Germany	Agaplesion Markus Krankenhaus	Frankfurt am Main
Germany	Centrum fuer Haematologie und Onkologie Bethanien	Frankfurt am Main
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt	Frankfurt am Main
Germany	Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung	Frankfurt am Main
Germany	Studiengesellschaft BSF	Halle
Germany	Asklepios Klinik Altona	Hamburg
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Asklepios Kliniken Nord	Hamburg
Germany	Haematologisch-Onkologische Praxis Eppendorf HOPE	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	SLK-Kliniken Heilbronn GmbH	Heilbronn
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
Spain	Centro Oncologico Galicia	A Coruña
Spain	Complejo Hospitalario Universitario A Coruna	A Coruña
Spain	Hospital Universitari Germans Trias - ICO Badalona	Badalona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital De Sant Joan Despi Moises Broggi	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	IOR- Instituto Quiron Dexeus	Barcelona
Spain	Hospital General De Granollers	Granollers
Spain	Hospital Sant Joan de Deu-Fundacio Althaia	Manresa
Spain	Complejo Hospitalario de Orense	Orense
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Hospital Universitari Sant Joan de Reus	Reus
Spain	Corporacio Sanitaria Universitaria Parc Tauli	Sabadell
Spain	Complejo Hospitalario Universitario De Santiago De Compostela	Santiago De Compostela
Spain	Hospital Universitario Mutua de Terrassa	Terrassa
Spain	Hospital Universitario Miguel Servet	Zaragoza
United States	USOR - New York Oncology Hematology, P.C.	Albany	New York
United States	Texas Oncology - Austin	Austin	Texas
United States	Ridley-Tree Cancer Center	California City	California
United States	Oncology Hematology Care Clinical Trials, LLC	Cincinnati	Ohio
United States	John Muir Clinical Research Center	Concord	California
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur	Decatur	Illinois
United States	Rocky Mountain Cancer Centers - Denver Midtown	Denver	Colorado
United States	USOR - Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Marin Cancer Care	Greenbrae	California
United States	The Oncology Institute of Hope	Los Angeles	California
United States	Texas Oncology - San Antonio Medical Center	San Antonio	Texas
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Rockwood Cancer Treatment Center	Spokane	Washington
United States	Texas Oncology - Northeast Texas	Tyler	Texas
United States	Northwest Cancer Specialists	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
BioNTech SE

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample	Blood sample taken post-surgery and pre-adjuvant chemotherapy.	4 to 8 weeks after surgery and within 7 days prior up to the day of start of AdCTx
Primary	Occurrence of ctDNA positivity in the first post-AdCTx blood sample	Blood sample taken post-adjuvant chemotherapy.	14 to 21 days after last AdCTx treatment
Secondary	Transfer of participants from the BNT000-001 study to the BNT122-01 clinical trial	The absolute and relative frequency of participants that will transfer to the BNT122-01 clinical trial from this epidemiological study will be reported.	4 weeks following Visit 1 (upon availability of ctDNA positivity status)