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)

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.

Trial Details

NCT ID
NCT07485296
Phase
PHASE2
Sponsor
Gruppo Oncologico del Nord-Ovest
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Postbiotix-HLA™ is a food supplement based on fermented FOS from Lactobacillus paracasei CNCM I-5220 postbiotic.
  • placebo capsule
  • Pembolizumab
Locations (sample)
  • Rozzano, Milano, Italy|45.38193,9.1559

Key Eligibility Criteria

  • Be willing and able to provide informed consent for the trial and its procedure;
  • Histological confirmation of HNSCC;
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) HNSCC;
  • For oropharyngeal cancers, known IHC p16+ and/or ISH HPV status;

For full eligibility, visit ClinicalTrials.gov.

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