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Cancer Vaccine

RO7198457 for Colorectal Cancer

Phase 2
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
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)
Must not have
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 known allergies, hypersensitivity, or intolerance to RO7198457 or its excipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the efficacy of RO7198457 to watchful waiting in patients with ctDNA positive, resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.

Who is the study for?
This trial is for adults with Stage II (high risk) or Stage III colorectal cancer that's been surgically removed and have detectable ctDNA. They must have started standard chemotherapy within 8 weeks post-surgery and completed at least 3 months of it. Exclusions include uncontrolled illnesses, prior certain treatments, unresolved toxicities from previous therapies (except hair loss and mild neuropathy), known allergies to RO7198457, recent major surgery, active hepatitis B/C, HIV positivity, or other current/past cancers with specific exceptions.
What is being tested?
The trial compares the effectiveness of a new drug called RO7198457 given intravenously against simply monitoring patients without intervention after they've had surgery for colorectal cancer. It focuses on those who still show signs of tumor DNA in their blood after surgery.
What are the potential side effects?
While the side effects are not detailed here, similar trials involving immunotherapy drugs like RO7198457 may cause immune-related reactions affecting various organs, infusion-related symptoms such as fever or chills, fatigue, skin issues like rash or itching, gastrointestinal problems including diarrhea or colitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I started chemotherapy within 8 weeks after surgery and have completed at least 3 months of it.
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I am 18 years old or older.
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My Stage II/III rectal or colon cancer was completely removed by surgery.
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My Stage II colon cancer is considered high risk due to one or more specific factors.
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My blood counts and organ functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 4 weeks and don't plan to during the trial.
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I am allergic to RO7198457 or its ingredients.
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I do not have any unmanaged ongoing illnesses.
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I have had my spleen removed.
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I have active hepatitis B or C.
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My tumor is diagnosed as MSI-high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease-free survival (DFS)
Secondary study objectives
Occurrence of treatment emergent adverse event (TEAE)
Overall survival (OS)
Relapse-free survival (RFS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: RO7198457Experimental Treatment1 Intervention
Participants will receive a recommended dose of RO7198457.
Group II: Observational GroupExperimental Treatment1 Intervention
Observational group will undergo watchful waiting, which is the standard of care in this setting.
Group III: Exploratory CohortExperimental Treatment1 Intervention
20 patients
Group IV: Colorectal Liver Metastasis (CLM) CohortExperimental Treatment1 Intervention
Group V: Biomarker CohortExperimental Treatment1 Intervention
15 patients

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,729 Total Patients Enrolled
BioNTech SELead Sponsor
77 Previous Clinical Trials
115,636 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
38 Previous Clinical Trials
11,219 Total Patients Enrolled

Media Library

RO7198457 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04486378 — Phase 2
Colorectal Cancer Research Study Groups: Colorectal Liver Metastasis (CLM) Cohort, Observational Group, Biomarker Cohort, Exploratory Cohort, RO7198457
Colorectal Cancer Clinical Trial 2023: RO7198457 Highlights & Side Effects. Trial Name: NCT04486378 — Phase 2
RO7198457 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04486378 — Phase 2
~107 spots leftby Nov 2026
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