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Cancer Vaccine
HPV Vaccine + M7824 for HPV-Associated Cancers
Phase 1 & 2
Waitlist Available
Led By Charalampos Floudas, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
p16+ Oropharyngeal cancers
Anal cancers;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is testing a vaccine for HPV combined with a drug called M7824 to see if it is more effective than either treatment alone for people with HPV associated cancer.
Who is the study for?
Adults (18+) with advanced or metastatic HPV-associated cancers, including cervical, anal, and p16-positive oropharyngeal cancers. Participants must have measurable disease and an ECOG performance status of <=2. Prior treatments are allowed under specific conditions. Adequate organ function is required, and effective contraception must be used.Check my eligibility
What is being tested?
The trial tests the safety and immune response to an HPV vaccine alone or combined with M7824 in patients with HPV-related cancers. Phase I involves multiple vaccine doses plus bi-weekly M7824 infusions for up to a year; Phase II precedes chemoradiation/surgery with two vaccine doses alone or with M7824.See study design
What are the potential side effects?
Potential side effects include typical reactions at the injection site from vaccines, as well as more serious risks associated with immunotherapy such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, possible blood disorders, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My throat cancer is p16 positive.
Select...
My cancer is located in the anal region.
Select...
My cervical cancer is advanced and cannot be cured with surgery or radiation.
Select...
I have a newly diagnosed HPV-positive throat or sinonasal cancer at stage II, III, IVA, or IVB.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer is advanced, spreads to other parts, and is HPV positive.
Select...
My condition is anal cancer.
Select...
My kidney function, measured by creatinine or GFR, is within the required range.
Select...
My cancer is in the vulva, vagina, penis, or rectum.
Select...
My throat cancer is p16 positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Level increase in CD3+ tumor infiltrating T cells post-treatment compared to pre-treatment
Safety and recommended phase II dose of PRGN-2009
Secondary outcome measures
3-year overall and relapse-free survival rate for PRGN-2009 alone
assess the safety of the recommended phase II dose (RP2D) of PRGN-2009 (HPV vaccine) alone
does the use of PRGN-2009 alone result in significantly prolonged survival
+5 moreSide effects data
From 2023 Phase 1 & 2 trial • 21 Patients • NCT0424728243%
Oral hemorrhage
36%
Constipation
36%
Fatigue
36%
Lymphocyte count decreased
36%
Epistaxis
29%
Dysphagia
29%
Weight loss
21%
Hyperglycemia
21%
Pruritus
21%
Wound infection
21%
Anemia
14%
Hyperthyroidism
14%
Lipase increased
14%
Rash acneiform
14%
White blood cell decreased
14%
Creatinine increased
14%
Gait disturbance
14%
Rash maculo-papular
14%
Tumor hemorrhage
14%
Alanine aminotransferase increased
14%
Oral pain
7%
Palpitations
7%
Aspartate aminotransferase increased
7%
Blood bilirubin increased
7%
Cough
7%
Flu like symptoms
7%
Hyponatremia
7%
Hypoxia
7%
Intraoperative head and neck injury
7%
Vaccination site lymphadenopathy
7%
Gastrointestinal disorders - Other, Sialadenitis
7%
Hematuria
7%
Respiratory failure
7%
Atrial fibrillation
7%
CPK increased
7%
Dermatitis radiation
7%
GGT increased
7%
Hypermagnesemia
7%
Hypophosphatemia
7%
Nausea
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Peripheral sensory neuropathy
7%
Aphonia
7%
Dehydration
7%
Edema limbs
7%
Mucositis oral
7%
Tumor pain
7%
Lung infection
7%
Sinus tachycardia
7%
Vasculitis
7%
Alkaline phosphatase increased
7%
Dysarthria
7%
Dysesthesia
7%
Dysgeusia
7%
Hypothyroidism
7%
Pain
7%
Skin ulceration
7%
Stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15)
Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1)
Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1)
Trial Design
4Treatment groups
Experimental Treatment
Group I: 4/Arm 2BExperimental Treatment8 Interventions
Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) plus M7824 at 1200 mg given as neoadjuvant or induction therapy.
Group II: 3/Arm 2AExperimental Treatment8 Interventions
Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) given as neoadjuvant or induction therapy.
Group III: 2/Arm 1BExperimental Treatment8 Interventions
Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) plus M7824 at 1200 mg.
Group IV: 1/Arm 1AExperimental Treatment7 Interventions
Human Papillomavirus Vaccine (HPV) vaccine at 1x10(11) Viral Particles (VP) Dose Level 1 (DL1) and at 5x10(11) VP Dose Level 2 (DL2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone scan
2015
Completed Phase 2
~250
CT scan
2017
Completed Phase 2
~2360
MRI
2009
Completed Phase 2
~1370
Brain MRI
2013
Completed Phase 4
~870
M7824
2020
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,628 Total Patients Enrolled
Charalampos Floudas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
642 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney and liver are functioning well.My liver enzymes are within the required range for the trial.I am in a trial where starting treatment after diagnosis could take more than 70 days.My throat cancer is p16 positive.I haven't had major surgery in the last 28 days.I have an autoimmune disease that could worsen with certain treatments, except for some.I've had one round of chemo and checkpoint therapy for my cancer.I am using or willing to use effective birth control during and up to 2 months after the study.My cancer is located in the anal region.I am not pregnant or breastfeeding.I use steroids only in forms that don't significantly affect my whole body.I am able to understand and agree to the study's procedures and risks.I have a mild autoimmune condition like diabetes type I or eczema, not needing strong immune system suppression.I haven't had certain cancer treatments or vaccines in the last 28 days.I am not on high-dose steroids or certain immune-suppressing drugs.I have had a transplant of tissue or an organ from another person.My cervical cancer is advanced and cannot be cured with surgery or radiation.I have a newly diagnosed HPV-positive throat or sinonasal cancer at stage II, III, IVA, or IVB.I can take care of myself but might not be able to do heavy physical work.I haven't had cancer, except for certain types, in the last 3 years.I refuse to accept blood products even if needed for my treatment.I have had a severe allergic reaction to monoclonal antibodies or their components.I have a serious illness like heart or liver disease that could make treatment risky.I am 18 years old or older.My cancer is advanced, spreads to other parts, and is HPV positive.My condition is anal cancer.My kidney function, measured by creatinine or GFR, is within the required range.My cancer is in the vulva, vagina, penis, or rectum.I have HIV or Hepatitis with undetectable viral loads and stable health.My brain or CNS cancer has been stable for over a month after treatment.I have cervical cancer.My cancer is in the vulva, vagina, penis, or rectum.My throat cancer is p16 positive.I had severe side effects from previous immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1A
- Group 2: 3/Arm 2A
- Group 3: 4/Arm 2B
- Group 4: 2/Arm 1B
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.
Are there any opportunities for enrolment in the trial at this time?
"Affirmative. According to clinicaltrials.gov, this study commenced on August 11th 2020 and has been recently updated on October 28th 2022. The trial is recruiting 76 patients from one single medical centre."
Answered by AI
How many patients have taken part in this exploration?
"Indeed, the clinicaltrials.gov database attests that this medical trial is actively seeking participants. It was initially published on August 11th 2020 and its details were last modified on October 28th 2022; 76 individuals need to be enrolled at a single site."
Answered by AI
What are the primary aims of this research initiative?
"The principal aim of this year-long study is to analyse the augmentation in CD3+ tumor infiltrating T cells following treatment compared to before. Secondary objectives include exploring the 2-fold increase rate in CD3+ tumor infiltrating lymphocytes (TILs) with PRGN-2009 and M7824, as well as determining 3 year overall and relapse free survival rates for both PRGN-2009 by itself or combined with M7824 when used as neoadjuvant/ induction therapy prior to standard care."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Met criteria
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