Phase II Study of Postbiotix-HLA to Reduce Immune Side Effects in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Treated with Pembrolizumab

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.

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)