This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    BNT122-01
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486378
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
BioNTech SE

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Stage II Colorectal Cancer Stage III Drug: RO7198457 intravenous (IV) Other: Observational group (no intervention) Phase 2

Detailed Description:
Patients will receive up to 15 doses of RO7198457 over the course of trial treatment.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : July 2027
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: RO7198457
Participants will receive a recommended dose of RO7198457.
 Drug: RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Observational Group
Observational group will undergo watchful waiting, which is the standard of care in this setting.
 Other: Observational group (no intervention)
watchful waiting
Experimental: Biomarker Cohort
15 patients
 Drug: RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Experimental: Exploratory Cohort
20 patients
 Drug: RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.
    • Start of new cancer therapy.
    • Loss to follow-up and non-cancer-related deaths are censored.

  4. Overall survival (OS) [ Time Frame: Through study completion, up to 5 years ]
    OS defined as the time from randomization to death from any cause.

  5. Change of ctDNA status (approximately every 3 months) [ Time Frame: Through study completion, up to 5 years ]
  6. Occurrence of treatment emergent adverse event (TEAE) [ Time Frame: 15 months ]
    TEAE, including Grade 3+, serious, fatal TEAE by relationship (adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0).

  7. Occurrence of dose reduction and discontinuation of RO7198457 due to a TEAE. [ Time Frame: 15 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 American Joint Committee on Cancer 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 evaluated after surgery.

  • 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 Performance Status of 0-1.
  • Patients must have adequate hematologic, bone marrow and organ function as defined by the protocol.
  • Adequate tumor material in formalin-fixed paraffin embedded 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 preferably within 8 weeks but no later than 10 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).

Exclusion Criteria:

  • Patients with uncontrolled intercurrent illness as defined by the protocol.
  • Diagnosed microsatellite instability 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 prostate-specific antigen level < 0.1 ng/mL.
    • Any curable cancer with a complete response 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 positive serology for hepatitis B (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy):

    • Based on a test for antibodies to hepatitis B core antigens (anti-HBc) and
    • 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 have had prior splenectomy.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486378


Contacts
Layout table for location contacts
Contact: BioNTech clinical trials patient information +49 6131 9084 ext 0 patients@biontech.de

Locations
Show Show 112 study locations
Sponsors and Collaborators
BioNTech SE
Genentech, Inc.
Investigators
Layout table for investigator information
Study Director: BioNTech Responsible Person BioNTech SE
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT04486378    
Other Study ID Numbers: BNT122-01
2020-000451-12 ( EudraCT Number )
U1111-1250-5294 ( Other Identifier: WHO Universal Trial Number (UTN) )
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioNTech SE:
Cancer
Colorectal Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases