Actively Recruiting
Effect of Postbiotics on Microbiota and Immune Response with Pembrolizumab as First-Line Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2026-03-20
45
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the postbiotic supplement Postbiotix-HLA™ on immune-related side effects in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) who are receiving pembrolizumab as their first-line standard treatment. This phase II, randomized, double-blind, placebo-controlled trial aims to explore how Postbiotix-HLA™ may influence the microbiota and systemic immune response during cancer treatment. Participants will be randomly assigned to receive either Postbiotix-HLA™ or a placebo capsule daily for four cycles, alongside pembrolizumab given every 21 days for up to approximately two years or until disease progression or intolerable side effects. The study compares the impact of these supplements on patients already treated with pembrolizumab, maintaining the standard care regimen while adding the investigational or placebo capsules. During the study, participants will provide blood, buccal swabs, stool, and possibly tumor tissue samples to assess changes in oral and fecal microbiota over two years. Researchers will monitor immune cells, tumor markers, and immune-related side effects, while also collecting patient-reported symptoms. The study is designed to carefully evaluate safety and treatment effects over a two-year period with ongoing assessments of health and disease status.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Histological confirmation of head and neck squamous cell carcinoma (HNSCC)
- Advanced or metastatic HNSCC (AJCC Stage IV), not suitable for curative surgery or radiation
- Known p16+ and/or HPV status for oropharyngeal cancers
- Positive PD-L1 Combined Proportionate Score (CPS)
- Neoplastic lesion accessible for tumor biopsy
- No prior systemic therapy for recurrent/metastatic HNSCC
- Eligible to receive pembrolizumab as standard care
- ECOG Performance Status of 2 or less
- Measurable disease according to RECIST 1.1
- Male or female aged 18 years or older
- Adequate kidney, liver, and bone marrow function as defined by specific laboratory values
- Female subjects of childbearing potential must have a negative pregnancy test and agree to contraception
- Male subjects of childbearing potential must agree to contraception
- Willingness to provide blood, buccal swabs, stool, and tissue samples for research
You will not qualify if you...
- Presence of 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 similar agents
- Active or recent autoimmune disease requiring systemic steroids above 10 mg prednisone daily or immunosuppressants, except certain controlled conditions
- Active or history of interstitial lung disease or pneumonitis requiring steroids
- Use or planned use of probiotics, yogurt, or bacterial fortified foods during treatment
- Systemic corticosteroids or immunosuppressive treatments within 14 days prior to study drug
- Uncontrolled adrenal insufficiency
- Medical conditions increasing risk or interfering with safety interpretation
- Not recovered to Grade 1 or less toxicities from prior therapy
- Pregnancy or breastfeeding
- History of serious heart conditions or recent heart events
- Certain abnormal laboratory test values below or above defined thresholds
- Known HIV infection
- Active Hepatitis B or C infection
- History of active tuberculosis
- Prior organ or bone marrow transplant
- Live vaccine within 30 days before starting study therapy, except inactivated flu vaccines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 cycles (approximately 2 years) or until tumor progression or intolerable toxicities
Participants receive pembrolizumab every 3 weeks along with either Postbiotix-HLA™ or placebo capsules daily for up to 4 cycles (approximately 12 weeks).
Pembrolizumab administered every 3 weeks; daily oral capsules for up to 4 cycles
Trial Site Locations
Total: 1 location
1
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
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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