Clinical Trials /

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

NCT04486378

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: BNT122-01
  • SECONDARY ID: 2020-000451-12
  • SECONDARY ID: U1111-1250-5294
  • NCT ID: NCT04486378

Conditions

  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III

Interventions

DrugSynonymsArms
RO7198457 intravenous (i.v.)Biomarker Cohort

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
RO7198457ExperimentalParticipants will receive a recommended dose of RO7198457.
  • RO7198457 intravenous (i.v.)
Observational GroupOtherObservational group will undergo watchful waiting, which is the standard of care in this setting.
    Biomarker CohortExperimental15 patients
    • RO7198457 intravenous (i.v.)
    Exploratory CohortExperimental20 patients
    • RO7198457 intravenous (i.v.)

    Eligibility Criteria

            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:
    
                   -  T4
    
                   -  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
                 levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
    
              -  Patients who developed metastatic disease.
    
              -  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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Disease-free survival (DFS)
    Time Frame:Through study completion, up to 5 years
    Safety Issue:
    Description:DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first: Locoregional recurrence or distant metastases as determined by an independent central radiology assessment. Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment. Death from any cause. Loss to follow-up is censored.

    Secondary Outcome Measures

    Measure:Relapse-free survival (RFS)
    Time Frame:Through study completion, up to 5 years
    Safety Issue:
    Description:RFS is defined as the time from randomization to occurrence of any of the following events, whichever occurs first: Locoregional recurrence or distant metastases as determined by the investigator. Death from any cause. Occurrence of second primary (same or other) cancer as determined by the investigator is ignored. Loss to follow-up is censored.
    Measure:Time to recurrence (TTR)
    Time Frame:Through study completion, up to 5 years
    Safety Issue:
    Description:TTR is defined as the time from randomization to occurrence of any of the following events (i.e., events related to the same cancer), whichever occurs first: Locoregional recurrence or distant metastases as determined by the investigator. Death from same cancer. Occurrence of second primary (same or other) cancer as determined by the investigator is ignored. Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored.
    Measure:Time to treatment failure (TTF)
    Time Frame:Through study completion, up to 5 years
    Safety Issue:
    Description:TTF is defined as the time from randomization to occurrence of any of the following events, whichever occurs first: Locoregional recurrence or distant metastases as determined by the investigator. Occurrence of second primary (same or other) cancer as determined by the investigator. Death from any cause except non-cancer related death. Loss to follow-up and non-cancer-related deaths are censored.
    Measure:Overall survival (OS)
    Time Frame:Through study completion, up to 5 years
    Safety Issue:
    Description:OS defined as the time from randomization to death from any cause.
    Measure:Change of Circulating tumor DNA (ctDNA) status (every 3 months)
    Time Frame:Through study completion, up to 5 years
    Safety Issue:
    Description:
    Measure:Occurrence of treatment emergent adverse event (TEAE)
    Time Frame:15 months
    Safety Issue:
    Description:TEAE, including Grade 3+, serious, fatal TEAE by relationship (AEs graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events, version 5.0 [CTCAE v5.0])
    Measure:Occurrence of dose reduction and discontinuation of IMP due to a TEAE.
    Time Frame:15 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:BioNTech SE

    Trial Keywords

    • Cancer
    • Colorectal Cancer

    Last Updated

    June 3, 2021