RecruitingCancer of the Head and Neck

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.

Sponsor: Providence Health & Services

You may qualify if…

✓ Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
✓ Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix C)
✓ Age 18 years or above.
✓ Laboratory values:
✓ WBC ≥2000/uL
✓ Hgb \>8.0 g/dl (patients may be transfused to reach this level)
✓ Platelets \>75,000 cells/mm3
✓ Serum creatinine clearance ≥ 50 mL/min measured or calculated by Cockcroft-Gault (C-G) equation

You may not qualify if…

✕ Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
✕ 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.
✕ Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
✕ 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. Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.
✕ Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
✕ History of organ transplant, including allogeneic stem cell transplantation.

Where it's recruiting

Oregon

Portland

Source: ClinicalTrials.gov · NCT04470024 · last updated 2026-04-13