Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Follow… (NCT07628062) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation
70 participantsStarted 2026-07-22
Plain-language summary
This Phase 2a/2 study evaluates the safety, tolerability, and efficacy of neoadjuvant and adjuvant NAI, hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). The study includes a Phase 2a safety lead-in followed by a randomized Phase 2 comparison of a de-intensified experimental chemoradiation approach versus standard-of-care chemoradiation.
Who can participate
Age range
18 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
. Age ≥ 18 years old.
. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Histologically confirmed squamous cell carcinoma of the oropharynx that is HPV-positive (p16 immunohistochemistry positive and/or HPV DNA positive). Patients with cervical lymph node metastases from an unknown primary can be included if p16-positive and likely OPSCC origin.
. Locally advanced, stage III/IV HPV-associated OPSCC that is a candidate for definitive chemoradiation. Specifically, tumors classified as T3 or T4 and/or node-positive disease (N2 or N3), without distant metastases (M0). Patients with very low-risk disease (e.g. T1-T2 N0-1) are excluded, as these might be handled with less intensive standard therapy or surgery rather than this trial approach.
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.
1This trial is still Phase 2 and hasn't started recruiting yet — given that, what do we actually know so far about the safety and effectiveness of combining a NAI, an HPV vaccine, and nab-paclitaxel before switching to a lower-dose radiation approach, and is that enough for you to feel comfortable with this path?
2The trial is comparing a de-intensified radiation approach against standard chemoradiation for my HPV-positive oropharyngeal cancer — what are the potential trade-offs in terms of treatment intensity, and should I be thinking about standard chemoradiation first given that it has a longer track record?
3Since the trial is measuring progression-free survival as its main outcome, what does that mean in practical terms for how my response to treatment would be tracked, and how would we know early on if things were or weren't working?
4This trial combines three different treatments — a NAI, an HPV vaccine, and nab-paclitaxel — before moving to reduced radiation, which is a complex regimen; how would managing side effects from all of these at once compare to what I'd experience with standard treatment?
5Because the trial is not yet recruiting, there could be a significant wait before I could even enroll — given where my cancer is right now, is waiting for this trial a realistic option, or does my situation require starting treatment sooner?
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
Progression-Free Survival (PFS)
Timeframe: Up to approximately 2 years after completion of treatment
. No prior definitive treatment for the current OPSCC. Patients must be treatment-naïve with respect to chemotherapy, radiation, or investigational therapy for this cancer. Prior diagnostic biopsy is allowed, but no prior curative surgery or radiation to the head and neck.
. Participants should be suitable for organ-preserving therapy (i.e., radiation) with no immediate need for surgical resection (the trial is non-surgical upfront).
Exclusion criteria
. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
0. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Per cisplatin prescribing information, female participants of child-bearing potential must agree to use effective contraception for up to 14 months and non-sterile male participants must agree to use a condom for up to 11 months after last dose of cisplatin. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.
. HPV-negative or Non-OPSCC: Tumors that are p16-negative or not in the oropharynx are excluded.
. Any evidence of distant metastases (M1 disease) excludes the patient, since the trial is for curative-intent local/regional therapy.
. Previous radiation in the head/neck region or prior chemotherapy/immunotherapy for this cancer disqualifies the patient. We require a clean baseline to assess our regimen.
. Active autoimmune disease or immunosuppression. The experimental arm includes immunotherapy (IL-15 receptor agonist and IBRX-042 vaccine), patients with active serious autoimmune disorders or those requiring immunosuppressive medications (e.g. chronic steroids \>10 mg prednisone daily) are excluded to avoid severe immune-related complications. Well-controlled or mild autoimmune conditions may be considered on a case-by-case basis if risk is low.
. Inadequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to baseline:
. Absolute neutrophil count (ANC) \< 1,500 cells/μL without granulocyte colony-stimulating factor support