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 now · Phase 2 · Has a placebo group
Conditions studied: Head & Neck Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07485296
- Run by
- Gruppo Oncologico del Nord-Ovest
- People needed
- 45
- Starts
- 2026-01-27
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (enrolling)
Full record on ClinicalTrials.gov
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