PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC

Inclusion Criteria

• •1. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• •2. Male or female ≥ 18 years of age at Visit 1 (Screening).
• •3. Pathologic diagnosis of Head and Neck Squamous Cell Carcinoma (HNSCC) of the oropharynx, hypopharynx, oral cavity, or larynx.
• •4. Ability and willingness to comply with the study's visits and assessment schedule.
• •5. At least one lesion (primary tumor, recurrent tumor, metastasis, or metastatic lymph node) that is surface accessible for CIVO injection that contains viable minimum tumor tissue volume and characteristics (e.g., based on clinical evaluation, available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports indicating lesion with appropriate viable tumor volume without excessive cysts or necrosis) and for which there is a planned surgical intervention. The patient's presentation, surgical and pathology plan may determine whether a lesion is eligible with respect to a given CIVO MID needle configuration.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• •7. Female patients who:
• •* Are postmenopausal for at least one year before the screening visit, OR
• •* Are surgically sterile, OR
• •* Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the Informed Consent Form (ICF) until 7 months after the CIVO injection OR agree to completely abstain from heterosexual intercourse.
• •* Agree to refrain from donating, or retrieving for their own use, ova until 7 months after the CIVO injection.
• •* Agree to refrain from breastfeeding until 7 months after the CIVO injection.
• •8. Male patients, even if surgically sterile (i.e., status post-vasectomy), who:
• •* Agree to practice effective barrier contraception from the time of signing the ICF until 7 months after the CIVO injection OR agree to completely abstain from heterosexual intercourse.
• •* Agree to refrain from fathering a child or donating sperm until 7 months after the CIVO injection.