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)
Trial Parameters
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Brief 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.
Eligibility Criteria
-Inclusion Criteria 1. Be willing and able to provide informed consent for the trial and its procedure; 2. Histological confirmation of HNSCC; 3. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) HNSCC; 4. For oropharyngeal cancers, known IHC p16+ and/or ISH HPV status; 5. Positive PD-L1 Combined Proportionate Score (CPS); 6. Presence of neoplastic lesion deemed safely accessible for tumor biopsy by the investigator; 7. No prior systemic therapy for RM HNSCC; 8. Eligible to receive pembrolizumab as the standard of care 9. ECOG Performance Status ≤ 2; 10. Measurable disease as per RECIST 1.1; 11. Males and females, ages ≥18; 12. Adequate renal function defined as calculated creatinine clearance ≥30 milliliters per minute (mL/min) per the Cockcroft and Gault formula or Serum creatinine \< 1.5 x upper limit of normal (ULN); 13. Adequate liver function defined by AST or ALT \< 3 x ULN (\< 5 x ULN if liver metastases are present), and total bilir