RO7198457 for Colorectal Cancer

Recruiting at 115 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioNTech SE

Must not be taking: Immunosuppressants, Investigational drugs

Disqualifiers: Uncontrolled illness, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

327 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, RO7198457, for individuals with certain types of colorectal cancer completely removed by surgery. Researchers aim to determine if this treatment is more effective than the current standard approach of watchful waiting, particularly in patients with circulating tumor DNA (tiny pieces of cancer DNA in the blood). Individuals who have had Stage II or III rectal cancer or Stage II (high risk) or III colon cancer, with surgery that removed all cancer, and who have detectable tumor DNA in their blood, might be suitable for this trial. Participants will either receive the experimental treatment RO7198457 or undergo close monitoring without additional treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RO7198457, whether used alone or with atezolizumab, is generally well-tolerated by patients with advanced tumors. In earlier studies, most patients experienced mild to moderate side effects, indicating that the side effects were usually not severe.

RO7198457 is still undergoing testing in mid-phase trials, meaning researchers continue to assess its safety. Its progression to this phase suggests it has passed initial safety checks, which may reassure those considering trial participation. Participants should always discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colorectal cancer, which often include chemotherapy and targeted therapies like bevacizumab or cetuximab, RO7198457 is unique because it leverages a personalized approach to target the cancer. Researchers are excited about this treatment because it utilizes a novel mechanism that tailors the therapy to the specific genetic makeup of the tumor. This personalized strategy has the potential to improve effectiveness and reduce side effects by precisely targeting cancer cells, offering a promising alternative to existing options.

What evidence suggests that RO7198457 might be an effective treatment for colorectal cancer?

Research has shown that RO7198457, a personalized mRNA vaccine, may help treat colorectal cancer. In earlier studies, patients who received RO7198457 experienced fewer recurrences of their tumors. The vaccine trains the immune system to identify and attack cancer cells by targeting proteins unique to each person's cancer. In this trial, some participants will receive RO7198457, while others will be part of an observational group undergoing standard watchful waiting. Early results suggest this method might be more effective than monitoring the condition alone in patients with high-risk colorectal cancer. Although more research is needed, the initial findings offer promise for those seeking new treatment options. ^{6 7 8 9 10}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

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.

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.

I am allergic to RO7198457 or its ingredients.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Observational group (no intervention)
• RO7198457

Trial Overview

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.

How Is the Trial Designed?

Group I: RO7198457 Experimental Treatment 1 Intervention

Participants will receive a recommended dose of RO7198457.

Group II: Observational Group Experimental Treatment 1 Intervention

Observational group will undergo watchful waiting, which is the standard of care in this setting.

Group III: Exploratory Cohort Experimental Treatment 1 Intervention

20 patients

Group IV: Colorectal Liver Metastasis (CLM) Cohort Experimental Treatment 1 Intervention

Group V: Biomarker Cohort Experimental Treatment 1 Intervention

15 patients

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04486378

Study Details | NCT04486378 | A Phase II ...

This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating ...

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app.1104health.com

app.1104health.com/start/physician/NCT04486378/

RO7198457 (mRNA-based Individualized Neoantigen- ...

This Phase II trial evaluates the efficacy of RO7198457, an individualized mRNA neoantigen vaccine, compared to watchful waiting in patients with ctDNA- ...

3.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04486378/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

A Phase II Clinical Trial Comparing the Efficacy of ...

This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with ...

4.

clinconnect.io

clinconnect.io/trials/NCT04486378

A Phase II Clinical Trial Comparing the Efficacy of - ClinConnect

The trial aims to determine whether using RO7198457 can help prevent the cancer from coming back in patients with Stage II (high risk) and Stage III colorectal ...

5.

crcmrd.com

crcmrd.com/?avada_portfolio=biontech-vaccine-for-crc-liver-mets

BioNTech Vaccine for CRC Liver Mets

This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 vaccine versus watchful waiting in ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04486378

Study Details | NCT04486378 | A Phase II ...

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 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03289962

NCT03289962 | A Study of Autogene Cevumeran ...

A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10190721/

Current and emerging therapeutic approaches for ...

Pembrolizumab improves CRC patients with dMMR/MSI-H based on the KEYNOTE-177 trial. Results showed a RR of up to 78% compared to 11% of patients with proficient ...

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onclive.com

onclive.com/view/ro7198457-atezolizumab-shows-early-phase-promise-in-advanced-solid-tumors

RO7198457/Atezolizumab Shows Early-Phase Promise in ...

RO7198457, in combination with atezolizumab (Tecentriq), was found to be well tolerated in patients with locally advanced or metastatic ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6319136/

Colorectal cancer vaccines: Tumor-associated antigens vs ...

Substantial improvement in treatment outcome could be achieved by development of efficient patient-individual CRC vaccination strategies. This mini-review ...