Plain-English translation of NCT07485296 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing whether a postbiotic supplement called Postbiotix-HLA™ can help reduce side effects and improve how well pembrolizumab (a standard immunotherapy drug) works for people with advanced head and neck cancer that has spread or come back. Half of the participants will receive the supplement along with pembrolizumab, while the other half will receive a placebo (inactive pill) along with the same immunotherapy. The study wants to see if the supplement helps your immune system fight cancer more effectively while causing fewer troubling side effects.
Pembrolizumab is a proven cancer treatment, but it can cause uncomfortable immune-related side effects in some patients. This trial is exploring whether adding a postbiotic supplement might improve how your gut bacteria support the medication's benefits while reducing those unwanted side effects.
You likely qualify if…
You likely don't qualify if…
You will be randomly assigned to take either the postbiotic supplement or a placebo (both as one capsule by mouth daily) for the first four cycles of treatment. During this time, you will also receive pembrolizumab as your standard cancer treatment every three weeks. The study will last up to 2 years or until your cancer progresses or you experience side effects you cannot tolerate. Throughout the trial, you will have regular visits for blood tests, imaging scans, and biopsies to monitor how the treatment is working and check for side effects.
AI-generated summary from trial data · Jul 18, 2026 · Not medical advice
Italy