Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04470024

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

Led by Providence Health & Services · Updated on 2026-04-13

56

Participants Needed

1

Research Sites

386 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Age 18 years or above
  • WBC count equal to or greater than 2000/uL
  • Hemoglobin greater than 8.0 g/dl (patients may receive transfusions to reach this level)
  • Platelet count greater than 75,000 cells/mm3
  • Serum creatinine clearance at least 50 mL/min measured or calculated by Cockcroft-Gault equation
  • Negative pregnancy test for women of childbearing potential
  • AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times upper limit of normal (ULN) or up to 5 times ULN for patients with liver metastases
  • Alkaline phosphatase less than or equal to 2.5 times ULN or up to 5 times ULN for patients with liver metastases
  • Total bilirubin less than or equal to 1.5 times ULN; if over 1.5, conjugated bilirubin must be within normal limits
  • Patients positive for hepatitis B core antibody eligible if HBV DNA is undetectable by qPCR
  • Patients positive for hepatitis C antibody eligible if HCV RNA is undetectable by qPCR
  • Patients positive for HIV 1/2 antibodies eligible if compliant with antiretroviral treatment, stable CD4 count over 300 for at least 6 months, and undetectable viral load
  • Ability to give informed consent and comply with study protocol
  • Expected lifespan greater than 12 weeks
  • Women of childbearing potential must have a negative pregnancy test within 5 days before starting the study
  • Males and women of childbearing potential must agree to use effective contraception during treatment and for 180 days after last dose
Not Eligible

You will not qualify if you...

  • Participation in another clinical study unless it is observational or during follow-up of an interventional study
  • Receipt of investigational anticancer therapy within 28 days or 5 half-lives before first study treatment dose
  • Use of chemotherapy, investigational agents, biologics, or hormonal therapy for cancer treatment during the study (non-cancer hormonal therapy allowed)
  • Radiotherapy to more than 30% of bone marrow or wide field radiation within 4 weeks before study treatment
  • Thoracic radiation over 30 Gy within 6 months before study treatment without recovery from toxicities
  • Major surgery within 28 days before first dose (except local palliative surgery)
  • History of organ transplant including stem cell transplant
  • Uncontrolled illness such as active infection, heart failure, unstable angina, lung disease, severe gastrointestinal conditions, active pneumonitis, or psychiatric/social issues limiting compliance
  • History of other primary malignancy within 1.5 years unless treated with curative intent and low recurrence risk
  • History of leptomeningeal carcinomatosis
  • Untreated brain metastases or carcinomatous meningitis; stable treated brain metastases allowed with no recent steroid or seizure medication changes
  • Active primary immunodeficiency
  • Active tuberculosis infection
  • Active autoimmune disease requiring systemic immunosuppression over physiologic corticosteroid doses (more than 10 mg/day prednisone or equivalent), with some exceptions
  • Receipt of live attenuated vaccine within 28 days before study treatment and during study plus 30 days after last dose
  • Known allergy or hypersensitivity to study drugs or excipients
  • Unresolved grade 2 or higher toxicities from prior anticancer therapy, except vitiligo, alopecia, or specified lab values
  • Grade 2 or higher neuropathy unless approved by investigators
  • Irreversible toxicity expected to worsen with study treatment unless approved by investigators
  • Prior immune-related toxicity requiring permanent discontinuation of checkpoint inhibitors or needing intensive immunosuppression
  • Use of systemic antibiotics within 7 days before first study treatment dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Portland Providence Medical Center

Portland, Oregon, United States, 97213

Actively Recruiting

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Research Team

G

George Morris

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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