Squamous cell carcinoma of head and neck

This study is for patients with a diagnosis of squamous cell carcinoma of the head and neck that is locoregionally advanced or recurrent and for which no surgical operation is planned.

Key Eligibility Criteria

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

• Are at least 18 years old.
• Have diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and/or larynx and/or of a lymph node(s) anywhere in the neck.
• Have at least 1 measurable tumor of ≥1 cm in longest diameter (or shortest diameter for lymph nodes).
• Are willing to consent to provide archival or fresh tumor biopsy samples per protocol.
• Are capable of giving signed informed consent which includes willingness to comply with all the requirements and restrictions listed in the informed consent form.
• Have an airway that is deemed safe and stable on flexible fiberoptic laryngoscopy (FFL) or are willing and able to undergo a procedure to protect your airway.
• Do not have cancer originating in the nasopharynx, paranasal sinuses, nasal passages, salivary glands, thyroid or parathyroid glands, esophagus, or skin.
• Have no known acute or chronic hepatitis B and/or known acute or chronic hepatitis C virus.
• Have no active or history of central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Have not undergone prior organ transplantation including allogenic stem-cell transplantation.

What to expect during the study

The study will consist of the following two Cohorts:

Locally Advanced Cohort – this cohort will have two treatment groups:

• RP3 plus CCRT (concurrent chemoradiation therapy) plus Nivolumab.
• Standard of care CCRT.

Recurrent Metastatic Cohort – this cohort will have one treatment group:

• RP3 in combination with carboplatin, paclitaxel, and nivolumab.

Each Cohort will have multiple sections. They are:

Locally Advanced Cohort

Screening Period	Up to 28 days
Safety Run_In Phase	Up To 1 Year
Randomization Phase	Up to 1 year
Follow-Up Period	Up to 105 days

Recurrent / Metastatic Cohort

Screening Period	Up to 28 days
Treatment Period	Up to 1 year
Follow-up Period	Up to 105 days

IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.