NCT07485296

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)

A Phase II, Randomized, Double-blind, Placebo Controlled, Multicenter Pilot Study to Evaluate the Effect of Postbiotics on Microbiota and Systemic Immunomodulation of Pembrolizumab as First Line Standard of Care in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head & Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Postbiotix-HLA™ is a food supplement based on fermented FOS from Lactobacillus paracasei CNCM I-5220 postbiotic.	Postbiotix-HLA™, 1 capsule (400 mg) daily PO from cycle 1 day 1 up to cycle 5 day1 (i.e. 4 cycles);
DIETARY_SUPPLEMENT	placebo capsule	Agente di carica: Mannitolo; Opercolo: Idrossipropilmetilcellulosa, Carbonato di calcio, Carragenina; Agente di carica: Cellulosa microcristallina; Agenti antiagglomeranti: Sali di magnesio di acidi grassi, Biossido di silicio.
DRUG	Pembolizumab	Pembrolizumab 200 mg q21 up to tumor progression, intolerable toxicities or 35 cycles (approximately 2 years of therapy).

Timeline

• Start date: 2026-01-27
• Primary completion: 2030-12-01
• Completion: 2032-12-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: Italy