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PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma

NCT05743777 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-18

No results posted yet for this study

Summary

The usual approach for patients who are not in a study is treatment with pembrolizumab, a type of immunotherapy drug. Immunotherapy works by allowing the immune system to detect your cancer and reactivate the immune response. This may help to slow down the growth of cancer and may cause cancer cells to die.

Conditions

  • Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Pembrolizumab

400 mg IV q6 weekly for a maximum of 18 cycles

DRUG

MET-4

Cycle 1: 5 g (10 capsules) on days -7 and -6 and 1.5 g (3 capsules) on day -5 and every day thereafter Cycle 2 onwards: 1.5 g (3 capsules) daily

DRUG

Placebo

Cycle 1: 5 g (10 capsules) on days -7 and -6 and 1.5 g (3 capsules) on day -5 and every day thereafter Cycle 2 onwards: 1.5 g (3 capsules) daily

Sponsors & Collaborators

  • NuBiyota

    collaborator OTHER

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Anna Spreafico · University Health Network, Princess Margaret Cancer Centre, Toronto ON Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2023-05-12
Completion
2023-05-12
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05743777 on ClinicalTrials.gov