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MET-4 with Chemoradiotherapy for Throat Cancer (ROMA LA-OPSCC2 Trial)

N/A
Waitlist Available
Led By Anna Spreafico, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be willing and able to provide: -Oropharyngeal swab, stool and blood specimen at protocol specified time points.
Age > 18 years, male or female.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

ROMA LA-OPSCC2 Trial Summary

This trialinvestigates if adding a bacterial strain, MET-4, to chemoradiotherapy is safe, tolerable and effective for treating a type of throat cancer. It involves 30 patients and will take 12 months.

Who is the study for?
This trial is for adults over 18 with a specific throat cancer (Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma) who can undergo standard chemoradiotherapy. Participants must be able to provide various biological samples and have no conditions affecting study safety or results interpretation, such as gastrointestinal disorders that impact medication absorption.Check my eligibility
What is being tested?
The trial tests the safety and effects of MET-4 bacteria strains alongside usual chemoradiotherapy in treating throat cancer. All patients will receive MET-4 orally, starting with a loading dose followed by maintenance until week 4 of treatment or until side effects become too severe.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include issues related to oral administration like nausea or trouble swallowing, reactions from gut bacteria changes due to MET-4, and typical chemotherapy and radiotherapy side effects like fatigue, skin irritation, and increased infection risk.

ROMA LA-OPSCC2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to provide mouth swab, stool, and blood samples when needed.
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I am older than 18 years.
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I have been diagnosed with a specific type of throat cancer.
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I am eligible for treatment aimed at curing my cancer with both radiation and chemotherapy.

ROMA LA-OPSCC2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative abundance of MET-4 associated bacterial strains in stool samples collected at week 4, end of CRT and 2-month follow-up timepoints.
Toxicity defined by CTCAE v.5.0.
Secondary outcome measures
Bacterial composition and diversity between baseline, week 4, end of CRT and 2 month follow-up samples
Bacterial composition and diversity of oral and stool samples in ROMA 1 (CRT alone) compared to ROMA 2 (CRT plus MET-4).
Other outcome measures
Correlation between blood immune profiling and changes in oral/intestinal microbiome in the context of CRT and MET-4 administration.
Correlation between oral/intestinal microbiome and radiomics imaging analysis.
Stool and serum metabolomic profiles before/after CRT and MET-4.

ROMA LA-OPSCC2 Trial Design

1Treatment groups
Experimental Treatment
Group I: MET-4Experimental Treatment1 Intervention
Subjects diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) will receive treatment with MET-4 in addition to standard of care CRT. MET-4 is administered orally as an initial daily loading dose over 2 days followed by a daily maintenance dose of MET-4 and will be administered until week 4 of CRT or unacceptable toxicity whichever occurs earlier and in the absence of criteria to discontinue MET-4.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,769 Total Patients Enrolled
NuBiyotaOTHER
8 Previous Clinical Trials
211 Total Patients Enrolled
Anna Spreafico, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
5 Previous Clinical Trials
337 Total Patients Enrolled

Media Library

MET-4 Clinical Trial Eligibility Overview. Trial Name: NCT03838601 — N/A
Head and Neck Squamous Cell Carcinoma Research Study Groups: MET-4
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: MET-4 Highlights & Side Effects. Trial Name: NCT03838601 — N/A
MET-4 2023 Treatment Timeline for Medical Study. Trial Name: NCT03838601 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Jan 2025