Actively Recruiting

Phase 2
Age: 18Years +
All Genders
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)

Led by Gruppo Oncologico del Nord-Ovest · Updated on 2026-03-20

45

Participants Needed

1

Research Sites

357 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide informed consent
  • Confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC)
  • Advanced or metastatic HNSCC not suitable for curative surgery or radiation (AJCC Stage IV)
  • For oropharyngeal cancers, known p16+ and/or HPV status
  • Positive PD-L1 Combined Proportionate Score (CPS)
  • Presence of safely accessible tumor lesion for biopsy
  • No prior systemic therapy for recurrent or metastatic HNSCC
  • Eligible to receive pembrolizumab as standard care
  • ECOG Performance Status of 0, 1, or 2
  • Measurable disease per RECIST 1.1 criteria
  • Male or female aged 18 years or older
  • Adequate kidney function (creatinine clearance ≥30 mL/min or serum creatinine <1.5 times upper limit of normal)
  • Adequate liver function (AST or ALT <3 times upper limit of normal; <5 times if liver metastases; total bilirubin <1.5 times upper limit except Gilbert Syndrome)
  • Adequate bone marrow function (WBC >2000/mm3, neutrophils >1500/mm3, platelets >100,000/mm3)
  • Negative pregnancy test within 72 hours before first study medication dose for women of childbearing potential
  • Willingness to use effective contraception during and for 120 days after study medication for women and men of childbearing potential
  • Willingness to provide blood, buccal swab, stool, and tissue samples for research
Not Eligible

You will not qualify if you...

  • Untreated brain metastases or unstable treated brain metastases
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or drugs targeting T-cell checkpoints
  • Active or recent autoimmune disease requiring systemic corticosteroids or immunosuppressive medications, except certain controlled conditions
  • Active interstitial lung disease or pneumonitis requiring steroids
  • Current use or planned use of probiotics, yogurt, or bacterial fortified foods during treatment
  • Systemic corticosteroid or immunosuppressive therapy within 14 days before first dose
  • Uncontrolled adrenal insufficiency
  • Medical conditions increasing risk or interfering with safety assessment
  • Not recovered to Grade 1 or better toxicity from prior therapy
  • Pregnant or breastfeeding women
  • History of myocarditis, severe heart failure, unstable angina, serious arrhythmias, recent myocardial infarction, or uncontrolled infection
  • Abnormal laboratory values outside specified limits (low blood counts, elevated liver enzymes, impaired kidney function)
  • Known HIV infection
  • Active Hepatitis B or C infection
  • Active tuberculosis
  • Previous organ or bone marrow transplant
  • Receipt of live vaccine within 30 days before study start (except inactivated influenza vaccine)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Clinico Humanitas

Rozzano, Milano, Italy, 20089

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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