Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC

Cannot have received: investigational anticancer therapy

Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.

Cannot have received: chemotherapy

Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment.

Cannot have received: biologic therapy

Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment.

Cannot have received: hormonal therapy for cancer

Exception: Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.

Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment.

Cannot have received: radiation therapy

Exception: Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy), excluding target lesions, Palliative radiation therapy cannot be administered less than 1 week prior to the first dose of study treatment.

Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.

Cannot have received: major surgical procedure

Exception: Local surgery of isolated lesions for palliative intent is acceptable.

Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment.

Cannot have received: checkpoint inhibitor

Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).

Cannot have received: systemic antibiotics

Receipt of systemic antibiotics ≤ 7 days prior to the first dose of study drug.