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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)

NCT07485296 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-20

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2030-12-31
Completion
2032-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485296 on ClinicalTrials.gov