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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 : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
BioNTech SE

Study Description
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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 (i.v.) Other: Observational group (no intervention) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 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
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Arm Intervention/treatment
Experimental: RO7198457
Participants will receive a recommended dose of RO7198457.
 Drug: RO7198457 intravenous (i.v.)
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 (i.v.)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Experimental: Exploratory Cohort
20 patients
 Drug: RO7198457 intravenous (i.v.)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.


Outcome Measures
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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.
    • 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 Circulating tumor DNA (ctDNA) status (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 (AEs graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events, version 5.0 [CTCAE v5.0])

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

Eligibility Criteria
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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 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 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).

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 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.
Contacts and Locations
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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
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Contact: BioNTech clinical trials patient information +49 6131 9084 ext 0 patients@biontech.de

Locations
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Sponsors and Collaborators
BioNTech SE
Investigators
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Study Director: BioNTech Responsible Person BioNTech SE
More Information
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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: November 8, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases