OncoMatch/Clinical Trials/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)
Is NCT07485296 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembolizumab for head & neck squamous cell carcinoma.
Treatment: Pembolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PD-L1 (CD274) positive Combined Proportionate Score (CPS) (positive CPS)
Positive PD-L1 Combined Proportionate Score (CPS)
Disease stage
Required: Stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Lab requirements
Blood counts
wbc > 2,000/mm3, neutrophils > 1,500/mm3, platelets > 100,000/mm3
Kidney function
calculated creatinine clearance ≥30 ml/min per cockcroft and gault formula or serum creatinine < 1.5 x uln
Liver function
ast or alt < 3 x uln (< 5 x uln if liver metastases are present), and total bilirubin < 1.5 x uln (except subjects with gilbert syndrome, who can have total bilirubin up to 3.0 mg/dl)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify