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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

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ClinicalTrials.gov Identifier: NCT04486378
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
BioNTech SE

Tracking Information
First Submitted Date  ICMJE July 20, 2020
First Posted Date  ICMJE July 24, 2020
Last Update Posted Date July 27, 2022
Actual Study Start Date  ICMJE March 8, 2021
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
Disease-free survival (DFS) [ Time Frame: Through study completion, up to 5 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
  • Relapse-free survival (RFS) [ Time Frame: Through study completion, up to 5 years ]
    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.
  • Time to recurrence (TTR) [ Time Frame: Through study completion, up to 5 years ]
    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.
  • Time to treatment failure (TTF) [ Time Frame: Through study completion, up to 5 years ]
    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.
  • Overall survival (OS) [ Time Frame: Through study completion, up to 5 years ]
    OS defined as the time from randomization to death from any cause.
  • Change of Circulating tumor DNA (ctDNA) status (every 3 months) [ Time Frame: Through study completion, up to 5 years ]
  • Occurrence of treatment emergent adverse event (TEAE) [ Time Frame: 15 months ]
    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])
  • Occurrence of dose reduction and discontinuation of IMP due to a TEAE. [ Time Frame: 15 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III
Intervention  ICMJE
  • Drug: RO7198457 intravenous (i.v.)
    RO7198457 administered as an IV infusion at protocol-specified intervals over 12 months.
  • Other: Observational group (no intervention)
    watchful waiting
Study Arms  ICMJE
  • Experimental: RO7198457
    Participants will receive a recommended dose of RO7198457.
    Intervention: Drug: RO7198457 intravenous (i.v.)
  • Observational Group
    Observational group will undergo watchful waiting, which is the standard of care in this setting.
    Intervention: Other: Observational group (no intervention)
  • Experimental: Biomarker Cohort
    15 patients
    Intervention: Drug: RO7198457 intravenous (i.v.)
  • Experimental: Exploratory Cohort
    20 patients
    Intervention: Drug: RO7198457 intravenous (i.v.)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2020)
201
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2027
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BioNTech clinical trials patient information +49 6131 9084 ext 0 patients@biontech.de
Listed Location Countries  ICMJE Belgium,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04486378
Other Study ID Numbers  ICMJE BNT122-01
2020-000451-12 ( EudraCT Number )
U1111-1250-5294 ( Other Identifier: WHO Universal Trial Number (UTN) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party BioNTech SE
Original Responsible Party BioNTech RNA Pharmaceuticals GmbH
Current Study Sponsor  ICMJE BioNTech SE
Original Study Sponsor  ICMJE BioNTech RNA Pharmaceuticals GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: BioNTech Responsible Person BioNTech SE
PRS Account BioNTech SE
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP