Colon Cancer Clinical Trial
A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer
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.
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 trial 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 of a 3 or a 6 month course of chemotherapy (including rest days).
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 levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
Patients who developed metastatic disease during screening/receiving standard of care treatment (not applicable for Exploratory Cohort).
Patients 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.
Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its excipients.
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 who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.
Patients who have had prior splenectomy.
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There are 46 Locations for this study
Glendale California, 91204, United States
Greenbrae California, 94904, United States
Orange California, 92868, United States
Fort Myers Florida, 33916, United States
West Palm Beach Florida, 33401, United States
Decatur Illinois, 62526, United States
Westwood Kansas, 66205, United States
Detroit Michigan, 48202, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Spokane Washington, 99218, United States
Brasschaat , 2930, Belgium
Charleroi , 6000, Belgium
Kortrijk , 8500, Belgium
La Louviere , 7100, Belgium
Leuven , 3000, Belgium
Berlin , 10117, Germany
Bochum , 44791, Germany
Frankfurt am Main , 60488, Germany
Frankfurt am Main , 60590, Germany
Hamburg , 22763, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Heilbronn , 74078, Germany
Kiel , 24116, Germany
Leipzig , 04103, Germany
Mainz , 55131, Germany
München , 81377, Germany
Recklinghausen , 45659, Germany
A Coruna , 15006, Spain
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 8036, Spain
Barcelona , 8041, Spain
Cordoba , 14004, Spain
Madrid , 28007, Spain
Madrid , 28027, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Orense , 32005, Spain
Pamplona , 31008, Spain
Santander , 39008, Spain
Santiago De Compostela , 15706, Spain
Valencia , 46014, Spain
Zaragoza , 50009, Spain
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