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Study identifier: NCT07485296 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

Effect of Postbiotics on Microbiota and Systemic Immunomodulation of Pembrolizumab as First-Line Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)

Condition: Head & Neck Squamous Cell Carcinoma  ·  Sponsor: Gruppo Oncologico del Nord-Ovest

PhasePhase 2
Planned participants45
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

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About this study

phase II, randomized, double-blind, placebo controlled, non pharmacological clinical trial that aims to determine the effect of postbiotics Postbiotix-HLA™ on immuno-related adverse events (irAEs) in patients with recurrent/metastatic head and neck squamous cell carcinoma (RM HNSCC) treated with in first line pembrolizumab as standard of care (SoC). The selected patient population will be randomised to receive the postbiotics Postbiotix-HLA™ or placebo for 4 cycles while in treatment with pembrolizumab as per clinical practice.

This description comes directly from the study's public registry record.

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Locations (1)

Istituto Clinico HumanitasRozzano, Milano, ItalyRecruiting

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