MET-4 / NuBiyota - LARVOL DELTA

MET4-IO: Feasibility Study of MET-4: Evaluating Fecal Microbiome Effects in Immunotherapy Patients (clinicaltrials.gov) - P2/3 | N=65 | Active, not recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Solid Tumor • BRAF

ROMA LA-OPSCC2: Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2 (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Biomarker • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Microbial Ecosystem Therapeutics 4 (MET4) elicits treatment-specific IgG responses associated with changes in gut microbiota in immune checkpoint inhibitor recipients with advanced solid tumors. (PubMed, J Immunother Cancer) - "These results demonstrate the induction of treatment-specific circulating humoral immunity by a bacterial consortium and suggest potential mechanisms by which gut microbes may contribute to antitumor immunity."

Checkpoint inhibition • Journal • Oncology • Solid Tumor • CD14 • FOXP3

Prospective manipulation of the gut microbiome with microbial ecosystem therapeutic 4 (MET4) in HPV-related locoregionally-advanced oropharyngeal cancer squamous cell carcinoma (LA-OPSCC) undergoing primary chemoradiation: ROMA2 study. (PubMed, Br J Cancer) - "ROMA-2 did not meet its primary ecologic endpoint, as no engraftment was observed in the overall cohort. Exploratory findings of engraftment in stage III patients warrants further investigation of microbiome interventions in this subgroup."

Journal • Metastases • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma

ROMA LA-OPSCC2: Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2 (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Aug 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2023 ➔ Jan 2025

Biomarker • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck