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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival (DFS)
Secondary outcome measures
Change of ctDNA status (approximately every 3 months)
Occurrence of dose reduction and discontinuation of RO7198457 due to a TEAE.
Occurrence of treatment emergent adverse event (TEAE)
+4 more

Trial Design

4Treatment 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: Biomarker CohortExperimental Treatment1 Intervention
15 patients

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,914 Total Patients Enrolled
BioNTech SELead Sponsor
64 Previous Clinical Trials
107,469 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,555 Total Patients Enrolled

Media Library

RO7198457 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04486378 — Phase 2
Colorectal Cancer Research Study Groups: 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different research centers are conducting this clinical trial?

"The primary locations for this study are University of Kansas Cancer Center in Westwood, Sarah Cannon (Tennessee Oncology - Nashville) and St Joseph Hospital of Orange; though the research is also being conducted out of a dozen other sites."

Answered by AI

Has the FDA sanctioned RO7198457 for intravenous use?

"RO7198457 intravenous (i.v.) has not yet been proven effective, however, there is some data supporting its safety which earns it a 2 on our Power scale."

Answered by AI

How many people have signed up for this clinical trial in total?

"To carry out the experiment, 201 participants who match the inclusion criteria will be needed. The trial sponsor, BioNTech SE, has selected various sites including University of Kansas Cancer Center in Westwood and Sarah Cannon (Tennessee Oncology - Nashville) to run the study."

Answered by AI

Are new patients currently being accepted into this trial?

"From what is available on clinicaltrials.gov, it seems as though this trial is still looking for volunteers. The most recent update was on October 24th, 2022 and the study was initially posted March 8th, 2021."

Answered by AI

Who else is applying?

What site did they apply to?
Texas Oncology-San Antonio Medical Center
Willamette Valley Cancer Institute and Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04486378.
All > Colorectal Cancer Glendale
~83 spots leftby Feb 2026
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