A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection

  • End date
    Jul 10, 2027
  • participants needed
  • sponsor
    BioNTech SE
Updated on 10 October 2022


This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.

Condition Colorectal Cancer Stage II, Colorectal Cancer Stage III
Treatment RO7198457 intravenous (i.v.), Observational group (no intervention)
Clinical Study IdentifierNCT04486378
SponsorBioNTech SE
Last Modified on10 October 2022


Yes No Not Sure

Inclusion Criteria

Patients must be a man or woman of at least 18 years of age
Patients 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 Stage II disease with any of the following risk factors for recurrence
Grade ≥ 3
Clinical presentation with bowel obstruction or perforation
Histological signs of vascular, lymphatic or perineural invasion
< 12 nodes examined
Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx)
(except for the Biomarker Cohort)
• ctDNA assay must be performed through this study or study BNT000-001 ctDNA
screening protocol
Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Patients must have adequate hematologic and organ function
Adequate tumor material in formalin-fixed paraffin embedded (FFPE) blocks or as sectioned tissue (only upon approval by sponsor) must be available (as described in the laboratory manual)
The patient has started a standard of care AdCTx within 8 weeks post-surgery and has completed at least 3 months of treatment

Exclusion Criteria

Patients with uncontrolled intercurrent illness
Diagnosed microsatellite instability (MSI) high tumors
Prior therapy with any of the following
Neo-adjuvant (radio)chemotherapy prior to surgery
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of trial treatment or anticipation of need for systemic immunosuppressive medication during trial treatment, with the exception of low dose steroids defined as 10 mg oral prednisone (or equivalent)
Current or recent (within the 28 days prior to randomization) treatment with another investigational drug
Toxicities from previous anti-cancer therapies that have not resolved to baseline
Patients who developed metastatic disease
Patients with known past or current malignancy other than inclusion diagnosis, except
levels or to Grade 1 or less except for alopecia and peripheral neuropathy
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
Patients who had major surgery (e.g., surgery requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or have surgery planned during the time the patient are expected to participate in the trial
Patients with active hepatitis B or C
Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its
Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening
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