A randomized double-blind placebo-controlled Phase 3 study of Debio 1143 in combo w/ platinum-based chemo & standard fractionation intensitymodulated radiotherapy in patients w/ locally advanced HNSCC suitable for definitive chemoradiotherapy | NYU Langone Health

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A randomized double-blind placebo-controlled Phase 3 study of Debio 1143 in combo w/ platinum-based chemo & standard fractionation intensitymodulated radiotherapy in patients w/ locally advanced HNSCC suitable for definitive chemoradiotherapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Locally Advanced Squamous Cell Carcinoma Of The Head And Neck
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1) Diagnosis in previously untreated LA-SCCHN (stage III, IVA or IVB) suitable for definitive CRT in at least 1 of the following sites: oropharynx, hypopharynx and/or larynx. 2) In oropharyngeal cancer patients, primary tumors must be HPV negative. 3) No hearing loss. 4) Adequate hematologic, renal and hepatic function.

You may not be eligible for this study if the following are true:

1) Primary tumor of nasopharyngeal, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site. 2) Metastatic disease. 3) Prior definitive or adjuvant RadioTherapy (RT) and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents.