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

Sponsor
BioNTech SE (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04813627
Collaborator
(none)
200
46
36
4.3
0.1

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
  • Procedure: Regular blood sample collection for ctDNA assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 2, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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).

  • 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.

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

  • Participant has received less than 3 months of AdCTx treatment.

  • Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
BioNTech SE
ClinicalTrials.gov Identifier:
NCT04813627
Other Study ID Numbers:
  • BNT000-001
First Posted:
Mar 24, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022