USO 24200
VERSATILE-003 (PDS0101-HNC-301) A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naive Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).
Disease Types: Head & Neck Cancer Research
Eligibility Requirements:
-Subject (or legally acceptable representative, if applicable) provides written informed consent for the study.
-Subject is ≥18 years of age on the day of signing the informed consent.
-Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck (HNS.
-Have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. As a guidance to the site investigators, tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
-Subject has adequate organ function.
-For female subjects defined as women of childbearing potential (WOCBP), a negative urine pregnancy test must be obtained during screening. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required. Women who are surgically sterile or at least 2 years postmenopausal do not require pregnancy testing.
-Male subjects of childbearing potential must agree to use a condom as an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
-Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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