Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Trea… (NCT05996523) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer
United States26 participantsStarted 2023-11-07
Plain-language summary
Background:
Cancers in and around the mouth associated with human papilloma virus (HPV) are common. Two treatments (the drug pembrolizumab and the HPV vaccine PRGN-2009) have been shown to work well when used individually against these cancers. Researchers want to find out if they might work better when used together.
Objective:
To test pembrolizumab combined with PRGN-2009 in people with HPV-positive cancers in and around the mouth.
Eligibility:
Adults aged 18 and older newly diagnosed with HPV-positive cancers in and around the mouth.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans. They may need to have a biopsy: A sample of tissue will be taken from the tumor.
PRGN-2009 is given as an injection under the skin. Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm.
Participants will have at least 3 clinic visits: At the first, they will receive both the drug and the vaccine; 15 days later, they will receive a second shot of the vaccine. At the third visit, about 1 week after the second, they will have follow-up tests.
During these visits, participants will give samples of blood, urine, and saliva. Imaging scans and biopsies will be repeated. They will have tests of their heart function.
Participants may opt to return for another follow-up visit about 1 month after their second dose of the vaccine.
Participants will have follow-up contacts by phone 3 and 6 months after starting the study. The calls will continue once a year for 5 years.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Subjects must have cytologically or histologically confirmed newly diagnosed stage I (T1,2 N1), II or III p16-positive oropharyngeal squamous cell carcinoma (SCC) planned for definitive therapy (surgery or chemoradiotherapy).
* Subjects must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Age \>=18 years.
* Eastern Cooperative Oncology Group \[ECOG\] performance status \<= 2.
* Adequate hematologic function at screening, as follows:
* Absolute neutrophil count (ANC) \>=1 x 10\^9/L;
* Hemoglobin (Hgb) \>= 9 g/dL;
* Platelets \>= 75,000/microliter.
* Adequate renal and hepatic function at screening, as follows:
* Serum creatinine \<= 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance \>= 40 mL/min for participant with creatinine levels \> 1.5 x ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl);
* Total bilirubin \<= 1.5 x ULN OR in subjects with Gilbert's syndrome, a total bilirubin \<= 3.0 x ULN;
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN, unless liver metastases are present, then values must be \<= 3 x ULN.
* Participants serologically positive for human immunodeficiency virus (HIV) Hepatitis B, or Hepatitis C are eligible if the viral loads are undetectable by quantitative polymerase chain reaction (PCR). Note: HIV positive participants must have CD4 count \>= 200 cells/mm\^3 at enrollmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants That Had a 2-fold Increase of Cluster of Differentiation 3 (CD3+) Tumor Infiltrating T Cells in Biopsies Performed Post-treatment Compared to Pre-treatment.
Timeframe: Pre-Treatment (Baseline) and anytime between Week 4-5 post treatment