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)

Recruiting Phase 2 Interventional Study
Head & Neck Squamous Cell Carcinoma
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Gruppo Oncologico del Nord-Ovest · Other
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About This Trial
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 randomi…
Trial Locations
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Eligibility Criteria
-Inclusion Criteria 1. Be willing and able to provide informed consent for the trial and its procedure; 2. Histological confirmation of HNSCC; 3. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) HNSCC; 4. For oropharyngeal cancers, known IHC p16+ and/or…
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