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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
EU CTIS ID: 2023-509516-28-00
What this study is testing
Demonstrate superiority of RO7198457 compared to “watchful waiting” in terms of DFS in chemotherapy pretreated patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be a man or woman of at least 18 years of age.
- Patients must be willing and able to adhere to the restrictions specified in this protocol.
- Adequate tumor material in formalin-fixed paraffin embedded (FFPE) blocks or as sectioned tissue (only upon approval by sponsor) must be available. Resections are preferred. The specimens should be submitted along with an associated pathology report.
- At least 5 tumor neoantigens identified in the provided tumor sample.
- 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 must have given informed consent indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial.
You likely can't join if
- Patients with uncontrolled intercurrent illness, including any of but not limited to: Severe infections within 4 weeks prior to the first dose of RO7198457 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia. Respiratory failure. Recent infections not meeting the criteria for severe infections, including the following: Signs or symptoms of infection within 2 weeks prior to the first dose of RO7198457. Received oral or IV antibiotics within 2 weeks prior to the first dose of RO7198457. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
- Patients who had major surgery 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 positive serology for hepatitis B based on a test for antibodies to hepatitis B core antigens (anti-HBc) and a negative test for antibodies to hepatitis B surface antigens (anti-HBs).
- Active Hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
- Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.
- Patients who were enrolled in this trial before.
See the full eligibility criteria
Who can join
- Patients must be a man or woman of at least 18 years of age.
- Patients must be willing and able to adhere to the restrictions specified in this protocol.
- Adequate tumor material in formalin-fixed paraffin embedded (FFPE) blocks or as sectioned tissue (only upon approval by sponsor) must be available. Resections are preferred. The specimens should be submitted along with an associated pathology report.
- At least 5 tumor neoantigens identified in the provided tumor sample.
- 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 must have given informed consent indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial.
- 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).
- Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx) (except for the Biomarker Cohort).
- Patients must have an ECOG Performance Status of 0-1.
- Patients must have organ and bone marrow function, in line with all of the following: ANC ≥1.5x 10E9/L (1500/mL) without granulocyte colony-stimulating factor support. Lymphocyte count ≥0.5x 10E9/L (500/µL). Platelet count ≥100x 10E9/L (100,000/µL) without transfusion. Hemoglobin ≥90 g/L (9 g/dL) patients may be transfused to meet this criterion. For patients not receiving therapeutic anticoagulation: INR or aPTT ≤1.5x upper limit of normal (ULN). For patients receiving therapeutic anticoagulation: stable anticoagulant regimen. GFR ≥30 mL/min. AST, ALT, and ALP ≤2.5x ULN. Bilirubin ≤1.5x ULN with the following exception: for patients with known Gilbert disease: bilirubin ≤3x ULN.
- Women must be either not of childbearing potential or if of childbearing potential, be practicing a highly effective method of birth control during the trial and for 28 d after receiving the last dose of RO7198457.
- Women of childbearing potential must have a negative serum pregnancy test.
- Men who are sexually active with women of childbearing potential and who have not had a vasectomy must agree to use a highly effective method of birth control during the trial and for 28 days after receiving the last dose of IMP.
What rules you out
- Patients with uncontrolled intercurrent illness, including any of but not limited to: Severe infections within 4 weeks prior to the first dose of RO7198457 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia. Respiratory failure. Recent infections not meeting the criteria for severe infections, including the following: Signs or symptoms of infection within 2 weeks prior to the first dose of RO7198457. Received oral or IV antibiotics within 2 weeks prior to the first dose of RO7198457. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
- Patients who had major surgery 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 positive serology for hepatitis B based on a test for antibodies to hepatitis B core antigens (anti-HBc) and a negative test for antibodies to hepatitis B surface antigens (anti-HBs).
- Active Hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
- Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.
- Patients who were enrolled in this trial before.
- Patients who are breastfeeding at screening visits 2 or 3, or who plan to breastfeed during the trial, starting after the start of treatment with RO7198457 and continuously until at least 90 d after receiving the last dose of RO7198457.
- Patients who have had prior splenectomy.
- Diagnosed 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 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 are currently enrolled in an ongoing clinical trial or trial that could interfere with the protocol-specified assessments.
- Patients with any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.