Clinical trial NCT04813627: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer Stage II
Colorectal Cancer Stage III
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Stage II (high risk)/III CRC after resection (R0) and that are scheduled to receive AdCTx will be enrolled in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample
timeFrame: 4 to 8 weeks (28 to 56 days) after surgery and within 7 days prior to start of AdCTx
Secondary outcomes:
measure: Transfer of participants from the BNT000-001 study to the BNT122-01 clinical trial
timeFrame: 4 weeks following Visit 1 (upon availability of ctDNA positivity status)
Other outcomes:
Locations:
city: California City
country: United States
facility: Ridley-Tree Cancer Center
state: California
city: Concord
country: United States
facility: John Muir Clinical Research Center
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Los Angeles
country: United States
facility: The Oncology Institute of Hope
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Denver Midtown
state: Colorado
city: Decatur
country: United States
facility: Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Albany
country: United States
facility: USOR - New York Oncology Hematology, P.C.
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care Clinical Trials, LLC
state: Ohio
city: Eugene
country: United States
facility: USOR - Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Spokane
country: United States
facility: Rockwood Cancer Treatment Center
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Antwerpen
country: Belgium
facility: ZNA Campus Middelheim
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brasschaat
country: Belgium
facility: VZW Algemeen Ziekenhuis KLINA
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Lucas
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel (UZ-VUB - Academisch Ziekenhuis)
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: La Louvière
country: Belgium
facility: Centres Hospitaliers Jolimont
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Namur
country: Belgium
facility: Clinique et Maternite Sainte-Elisabeth (CMSE)
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre d'ottignies (CSPO)
city: Ronse
country: Belgium
facility: Algemeen Ziekenhuis (AZ) Glorieux
city: Verviers
country: Belgium
facility: Centre Hospitalier Regional, CHR
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dr. med. B. Heinrich, Prof. M. Bangerter MD
city: Berlin
country: Germany
facility: Charité Campus Mitte (CCM) - Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: Universitaetsklinikum St. Josef-Hospital Bochum
city: Bonn
country: Germany
facility: Medizinische Klinik III, Universitätsklinikum Bonn
city: Donauwoerth
country: Germany
facility: Cancer Center Donauwoerth and Dachau
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Elmshorn
country: Germany
facility: Asklepios MVZ Elmshorn
city: Frankfurt am Main
country: Germany
facility: Centrum fuer Haematologie und Onkologie Bethanien
city: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
city: Halle
country: Germany
facility: Studiengesellschaft BSF
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Haematologisch-Onkologische Praxis Eppendorf HOPE
city: Hamburg
country: Germany
facility: Asklepios Kliniken Nord
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Kiel
country: Germany
facility: Staedtisches Krankenhaus Kiel gGmbH
city: Mainz
country: Germany
facility: Internistische Schwerpunktpraxis Hamatologie und Onkologie
city: Mannheim
country: Germany
facility: Ze:ro Arztpraxen
city: München
country: Germany
facility: Klinikum der Universität München, Medizinische Klinik und Poliklinik III
city: München
country: Germany
facility: Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach
city: Recklinghausen
country: Germany
facility: Prosper Hospital
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Weißenfels
country: Germany
facility: Asklepios Klinik Weissenfels
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken (HSK)
city: Witten
country: Germany
facility: Forschungszentrum Ruhr
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: A Coruña
country: Spain
facility: Centro Oncologico Galicia
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias - ICO Badalona
city: Barcelona
country: Spain
facility: IOR- Instituto Quiron Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital De Sant Joan Despi Moises Broggi
city: Granollers
country: Spain
facility: Hospital General De Granollers
city: Manresa
country: Spain
facility: Hospital Sant Joan de Deu-Fundacio Althaia
city: Orense
country: Spain
facility: Complejo Hospitalario de Orense
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Universitaria Parc Tauli
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario De Santiago De Compostela
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: BioNTech SE
name: BioNTech Responsible Person
role: STUDY_DIRECTOR
References: