Clin2
NCT04534205Possibly a fitRecruiting

Testing BNT113 plus pembrolizumab versus pembrolizumab alone

Unresectable Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck CancerRecurrent Head and Neck Cancer

Treatments studied

Part of Cancer clinical trials.

This trial studies whether adding BNT113 to pembrolizumab works better and is safe for people with HPV16-positive head and neck cancer that can’t be cured with local treatments. It also compares outcomes to pembrolizumab alone, specifically for tumors that show PD-L1 in testing.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
350 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must agree to and sign the trial’s pre-screening consent form before any study checks.
  • Your cancer must be recurrent or metastatic HPV16-positive head and neck squamous cancer that isn’t curable with local treatments.
  • Your tumor test must show PD-L1 positivity (CPS 1 or higher) using an approved lab test (22C3).
  • You cannot have had prior cancer medicines that treat the whole body for this incurable recurrent/metastatic situation (treatment over 180 days ago for some earlier local cancers may be allowed).
  • You need at least one measurable tumor spot on scans (and certain past radiation-area spots may count if they’ve clearly grown).
  • You must provide a tumor tissue sample from a past biopsy or surgery (or a fresh biopsy if that’s standard for you before starting treatment).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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