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~88 spots leftby Nov 2026

RO7198457 for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+110 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: BioNTech SE

Must not be taking: Immunosuppressants, Investigational drugs

Disqualifiers: Uncontrolled illness, Metastatic disease, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic immunosuppressive medication or have recently taken another investigational drug. It's best to discuss your specific medications with the trial team.

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening protocol

I started chemotherapy within 8 weeks after surgery and have completed at least 3 months of it.

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Exclusion Criteria

Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening

I haven't had major surgery in the last 4 weeks and don't plan to during the trial.

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)

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 15 doses of RO7198457

15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

Observational group (no intervention) (Behavioural Intervention)
RO7198457 (Cancer Vaccine)

Trial OverviewThe 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.

Participant Groups

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