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Cancer Vaccine

Autophagosome Vaccine + Immunotherapy for Head and Neck Cancer

Phase 1

Recruiting

Research Sponsored by Providence Health & Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine clearance ≥ 50 mL/min measured or calculated by Cockcroft-Gault (C-G) equation

Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only if HBV DNA is non-detectable by qPCR.

Must not have

History of organ transplant, including allogeneic stem cell transplantation

History of another primary malignancy except for:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 2 years, and study completion

Awards & highlights

Summary

This trial is testing a new combination of drugs to treat head and neck cancer that has come back or spread. The new drugs are being tested to see if they are safe and effective.

Who is the study for?

Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who are in relatively good health, as indicated by ECOG performance status of 0-2. They must have adequate organ function, no major surgeries within the last month, not be on high-dose steroids for autoimmune diseases, and cannot be pregnant or fathering a child without using contraception. HIV-positive patients can join if they're stable on antiretroviral therapy.

What is being tested?

The trial is testing a new cancer vaccine called DPV-001 combined with an anti-PD-1 immunotherapy drug named INCMGA00012. Some participants will also receive INCAGN01876, which activates immune cells via GITR to see if it enhances treatment effects against HNSCC. The study has two arms comparing these treatments.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. There may also be risks related to activating the immune system that could cause inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough to clear waste from my blood.

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I have hepatitis B but my viral load is undetectable.

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I am 18 years old or older.

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I have hepatitis C but my viral load is undetectable.

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I have hepatitis C but my viral load is undetectable.

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My cancer is a recurring or spreading head and neck squamous cell carcinoma.

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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I have hepatitis B but my viral load is undetectable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ or stem cell transplant.

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I have had cancer before, but it was a different type than my current diagnosis.

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I had a severe reaction to previous immunotherapy that required stopping the treatment or long-term immune suppression.

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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.

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I do not have any serious illnesses that my doctor thinks could interfere with the study.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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I take more than 10 mg/day of prednisone or equivalent for an autoimmune disease.

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My early-stage cancer was treated successfully with no signs of disease.

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I have had cancer spread to the lining of my brain and spinal cord.

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I do not have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year, 2 years, and study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year, 2 years, and study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years, and study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events Assessment

Secondary study objectives

Duration of disease control

ORR, DOR, DCR

Overall survival (OS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 (CLOSED TO ENROLLMENT)Experimental Treatment3 Interventions

Vax + anti-GITR + delayed anti-PD-1

Group II: Arm 1Experimental Treatment2 Interventions

Vax + delayed anti-PD-1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCAGN01876

2016

Completed Phase 2

~250

Retifanlimab

Not yet FDA approved

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor

121 Previous Clinical Trials

823,591 Total Patients Enrolled

Media Library

DPV-001 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04470024 — Phase 1

Head and Neck Cancers Research Study Groups: Arm 2 (CLOSED TO ENROLLMENT), Arm 1

Head and Neck Cancers Clinical Trial 2023: DPV-001 Highlights & Side Effects. Trial Name: NCT04470024 — Phase 1

DPV-001 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04470024 — Phase 1

~16 spots leftby Dec 2025

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