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
Study Details
Study Description
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 21 months thereafter, according to CRC stages and disease characteristics.
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 adjuvant chemotherapy 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.
Participants receive no therapeutic intervention as part of this study.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Participants with R0 resected Stage II (high risk) or Stage III CRC 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. |
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
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Outcome Measures
Primary Outcome Measures
- Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample [4 to 8 weeks after surgery and within 7 days prior up to the day of start of AdCTx]
Blood sample taken post-surgery and pre-adjuvant chemotherapy.
- Occurrence of ctDNA positivity in the first post-AdCTx blood sample [14 to 21 days after last AdCTx treatment]
Blood sample taken post-adjuvant chemotherapy.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Age ≥ 18 years old at time of signing the informed consent form.
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Ability to comply with the study protocol, in the investigator's judgment.
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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):
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T4
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Grade ≥ 3
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Clinical presentation with bowel obstruction or perforation
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Histological signs of vascular, lymphatic or perineural invasion
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< 12 nodes examined
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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.
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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 according to the treating physician or investigator.
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Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
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Adequate end-organ function.
Exclusion Criteria:
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Induction of neoadjuvant systemic therapy prior to resection of CRC.
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Prior systemic investigational therapy.
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Positive serology for hepatitis B (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy):
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Positive test for antibodies to hepatitis B core antigens (anti HBc) and
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Negative test for antibodies to hepatitis B surface antigens (anti HBs).
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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.
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Participant has a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.
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Residual tumor classification following surgery other than R0 (microscopic margin-negative resection).
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Diagnosis with disease other than Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 following surgery.
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Participant has not started standard of care AdCTx within 8 weeks post-surgery.
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Participant has received less than 3 months of AdCTx treatment.
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Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | John Muir Clinical Research Center | Concord | California | United States | 94520 |
2 | Marin Cancer Care | Greenbrae | California | United States | 94904 |
3 | The Oncology Institute of Hope | Los Angeles | California | United States | 90033 |
4 | Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur | Decatur | Illinois | United States | 62526 |
5 | Orchard Healthcare Research Inc. | Skokie | Illinois | United States | 60077 |
6 | Rockwood Cancer Treatment Center | Spokane | Washington | United States | 99204 |
7 | Imelda Ziekenhuis | Bonheiden | Belgium | 2820 | |
8 | VZW Algemeen Ziekenhuis KLINA | Brasschaat | Belgium | 2930 | |
9 | Algemeen Ziekenhuis Sint-Lucas | Brugge | Belgium | 8310 | |
10 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
11 | Centres Hospitaliers Jolimont | La Louvière | Belgium | 7100 | |
12 | Clinique et Maternite Sainte-Elisabeth (CMSE) | Namur | Belgium | 5000 | |
13 | Clinique Saint-Pierre d'ottignies (CSPO) | Ottignies | Belgium | 1340 | |
14 | Algemeen Ziekenhuis (AZ) Glorieux | Ronse | Belgium | 9600 | |
15 | Centre Hospitalier Regional, CHR | Verviers | Belgium | 4800 | |
16 | Gemeinschaftspraxis Dr. med. B. Heinrich, Prof. M. Bangerter MD | Augsburg | Germany | 86150 | |
17 | Universitaetsklinikum St. Josef-Hospital Bochum | Bochum | Germany | 44791 | |
18 | Cancer Center Donauwoerth and Dachau | Donauwoerth | Germany | 86609 | |
19 | St. Johannes Hospital | Dortmund | Germany | 44137 | |
20 | Centrum fuer Haematologie und Onkologie Bethanien | Frankfurt am Main | Germany | 60389 | |
21 | Agaplesion Markus Krankenhaus | Frankfurt am Main | Germany | 60431 | |
22 | Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung | Frankfurt am Main | Germany | 60488 | |
23 | Asklepios Klinik St. Georg | Hamburg | Germany | 20099 | |
24 | Haematologisch-Onkologische Praxis Eppendorf HOPE | Hamburg | Germany | 20249 | |
25 | Asklepios Klinik Altona | Hamburg | Germany | 22763 | |
26 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
27 | SLK-Kliniken Heilbronn GmbH | Heilbronn | Germany | 74078 | |
28 | Ze:ro Arztpraxen | Mannheim | Germany | 68723 | |
29 | Klinikum der Universitat München, Medizinische Klinik und Poliklinik III | München | Germany | 81377 | |
30 | Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach | München | Germany | 81737 | |
31 | Asklepios Klinik Weissenfels | Weißenfels | Germany | 06667 | |
32 | Helios Dr. Horst Schmidt Kliniken (HSK) | Wiesbaden | Germany | 65199 | |
33 | Forschungszentrum Ruhr | Witten | Germany | 58455 | |
34 | Complejo Hospitalario Universitario A Coruna | A Coruña | Spain | 15006 | |
35 | Centro Oncologico Galicia | A Coruña | Spain | 15009 | |
36 | IOR- Instituto Quiron Dexeus | Barcelona | Spain | 08028 | |
37 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
38 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08041 | |
39 | Hospital De Sant Joan Despi Moises Broggi | Barcelona | Spain | 08970 | |
40 | Hospital General De Granollers | Granollers | Spain | 08402 | |
41 | Hospital Sant Joan de Deu-Fundacio Althaia | Manresa | Spain | 08243 | |
42 | Complejo Hospitalario de Orense | Orense | Spain | 32005 | |
43 | Complejo Hospitalario de Navarra | Pamplona | Spain | 31008 | |
44 | Hospital Universitari Sant Joan de Reus | Reus | Spain | 43204 | |
45 | Complejo Hospitalario Universitario De Santiago De Compostela | Santiago De Compostela | Spain | 15706 | |
46 | Hospital Universitario Mutua de Terrassa | Terrassa | Spain | 08221 |
Sponsors and Collaborators
- BioNTech SE
Investigators
- Study Director: BioNTech Responsible Person, BioNTech SE
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BNT000-001