Inclusion Criteria:

• Age ≥18 years.

• Histological confirmation of squamous cell carcinoma of larynx or hypopharynx.

• Measurable disease as defined in Section 11.0 see protocol

• Non-measurable disease, as defined in Section 11.0 see protocol

• ECOG Performance Status (PS) ≤3

• Negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done ≤__ days prior to registration, for women of childbearing potential only.

• Ability to complete questionnaire(s) by themselves or with assistance.

• Provide written informed consent.

• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

• Willing to provide mandatory tissue and/or blood samples for correlative research purposes. See protocol

Exclusion Criteria:

• Any of the following:

  • Pregnant persons

  • Nursing persons

  • Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception

• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

• Uncontrolled intercurrent illness including, but not limited to:

  • ongoing or active infection

  • symptomatic congestive heart failure

    unstable angina pectoris

  • cardiac arrhythmia

  • or psychiatric illness/social situations that would limit compliance with study requirements

• History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/25/2025. Questions regarding updates should be directed to the study team contact.