Overview
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.
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.