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Cancer Vaccine
Autophagosome Vaccine + Immunotherapy for Head and Neck Cancer
Phase 1
Waitlist Available
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 years, and study completion
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events Assessment
Secondary outcome measures
Duration of disease control
ORR, DOR, DCR
Overall survival (OS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental 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
Retifanlimab
Not yet FDA approved
INCAGN01876
2016
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,479 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nerve damage that affects my daily activities.I have taken short-term steroids for allergies or as premedication for treatments.My kidneys work well enough to clear waste from my blood.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.I use steroids only in forms like creams, eye drops, joint injections, or nasal sprays.I have had an organ or stem cell transplant.I have not taken antibiotics in the week before starting the study drug.I have had cancer before, but it was a different type than my current diagnosis.I had a severe reaction to previous immunotherapy that required stopping the treatment or long-term immune suppression.My cancer was treated over 1.5 years ago, with no signs of return.I am not on any cancer treatments but may be on hormone therapy for other reasons.I have had radiation therapy in my chest area of more than 30 Gy and have recovered from all side effects without needing steroids.I have brain metastases that are stable, treated, and I'm not on high-dose steroids.I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.My hemoglobin level is above 8.0 g/dl, possibly after a transfusion.I do not have any serious illnesses that my doctor thinks could interfere with the study.I am a woman who can have children and have a recent negative pregnancy test.I have not received a live vaccine in the last 28 days.I have hepatitis B but my viral load is undetectable.I am 18 years old or older.I had skin cancer (not melanoma) treated and currently show no signs of it.I've had local treatment for symptom relief, not within the last week.I use medication occasionally for my asthma.I take more than 10 mg/day of prednisone or equivalent for an autoimmune disease.I have hepatitis C but my viral load is undetectable.I agree to use birth control during and for 6 months after treatment.I don't have lasting side effects from cancer treatment, except for possible hair loss, skin color changes, or specific lab value changes.I am on corticosteroid therapy for adrenal or pituitary issues, not for autoimmune disease.I have hepatitis C but my viral load is undetectable.My cancer is a recurring or spreading head and neck squamous cell carcinoma.I agree to use birth control during and for 6 months after treatment.You are expected to live for at least 12 more weeks.My early-stage cancer was treated successfully with no signs of disease.I have had cancer spread to the lining of my brain and spinal cord.My alkaline phosphatase levels are within the normal range, even with liver metastases.I do not have an active tuberculosis infection.I am able to care for myself and perform daily activities.I am 18 years old or older.I have hepatitis B but my viral load is undetectable.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants will this clinical trial accommodate?
"Affirmative, the clinicaltrials.gov platform contains records of this particular trial being currently open for enrollment. The initial posting was on August 5th 2021 and it has been updated as recently as September 9th 2022; 56 patients are needed from one specific centre to participate in this study."
Answered by AI
What other investigations have been conducted utilizing DPV-001?
"At present, there are 26 investigations into DPV-001. Of those studies, 3 have reached Phase 3 clinical trials. The primary site for these assessments is A Coruña in Virginia but this medication has been studied at 810 various locations globally."
Answered by AI
Has this particular clinical trial been conducted previously?
"Currently, there are 26 active trials for DPV-001 spread across 117 cities and 43 countries. Incyte Corporation's initial study of this pharmaceutical began in 2016; the trial tested DPV-001 on 325 patients before it was approved to move onto Phase 1 drug testing. Subsequently, 9 further studies have been conducted to evaluate its efficacy."
Answered by AI
Are there still available positions for volunteers within this research endeavor?
"Clinicaltrials.gov informs us that this trial is actively looking for participants, having been posted on August 5th 2021 and most recently adjusted on September 9th 2022."
Answered by AI
What are the chances of adverse effects from taking DPV-001?
"With limited clinical data supporting efficacy and safety, DPV-001 was assigned a score of 1 on the Power scale."
Answered by AI
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