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HPV-Positive Oropharyngeal Squamous Cell CarcinomaPhase 2NCT07628062

Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation

A Phase 2 study testing Nogapendekin Alfa Inbakicept (NAI), hAd5-HPV Vaccine (IBRX-042) and Nab-Paclitaxel in people with HPV-Positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by ImmunityBio, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nogapendekin Alfa Inbakicept (NAI), hAd5-HPV Vaccine (IBRX-042) and Nab-Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
22 Jul 2026to 27 Jun 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
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  • Participants should be suitable for organ-preserving therapy (i.e., radiation) with no immediate need for surgical resection (the trial is non-surgical upfront).
  • Must be willing to accept the randomized treatment assignment after the safety lead-in. During the initial safety phase, all participants receive experimental therapy; once randomization begins, patients and investigators will not choose the arm - it will be assigned by the randomization schedule. Enrolled patients should have no clear contraindication to either arm's therapy (for instance, a patient who absolutely cannot receive cisplatin due to allergy or comorbidity might not be suitable, since cisplatin is required in both arms). The inclusion/exclusion criteria are structured to ensure a homogeneous population suitable for both the experimental approach and SOC chemoradiation.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • 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.

Who cannot join

  • 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
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  • Platelet count < 100,000/μL without transfusion
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) > 2.5 × ULN, with the following exception:
  • Participants with documented liver metastases: AST and/or ALT > 5 × ULN
  • Serum bilirubin ≤ 3 × ULN
  • Creatinine clearance ≤ 50 mL/min (calculated using the Cockcroft-Gault formula).
  • Serum albumin < 3.0 g/dL.
  • Significant cardiovascular disease (such as New York Heart Association cardiac disease class II or greater), myocardial infarction within 3 months prior to baseline, unstable arrhythmias, or unstable angina.
  • Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350 cells/μL and/or a detectable HIV viral load.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Pregnant and nursing women.

About this study

Official title: Open-Label, Single-Arm Phase 2 Study Of Nogapendekin Alfa Inbakicept, PD-L1 T-HaNK, And Bevacizumab And Randomized Phase 2B Study Of Nogapendekin Alfa Inbakicept, Bevacizumab, And Tumor Treatment Fields With Or Without PD-L1 T-HaNK In Participants With Recurrent Or Progressive Glioblastoma

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.

Read the detailed description

This is a two-part study to evaluate the safety, tolerability, and efficacy of neoadjuvant and adjuvant therapy in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC).

In part 1 (phase 2a), the first 10 eligible participants will be enrolled into a single-arm safety cohort and receive the experimental treatment regimen. This lead-in will assess safety, tolerability, and early biomarker response to the neoadjuvant combination.

All 10 participants in part 1 (phase 2a) receive the investigational therapy (NAI, IBRX-042, Nab-paclitaxel) followed by standard of care (SOC) radiation with concomitant cisplatin, and NAI and IBRX-042 post radiation.

The key primary objective in safety lead-in includes evaluating and confirming there are no unexpected severe adverse interactions between the combination agents. Early efficacy signals such as clearance of circulating tumor HPV DNA (using the NavDx® assay) will also be assessed to gauge biomarker response.

Upon successful completion of the safety lead-in (defined by acceptable safety profile and tolerability of the experimental regimen in the first 10 patients), part 2 (phase 2) will expand into an exploratory randomized trial, which will be a randomized 1:1 comparison between two arms, the experimental arm (arm A) and a SOC control arm (arm B).

Randomization will be stratified by tumor stage and smoking history to ensure balance between arms of important risk factors. This part of the study will evaluate comparative efficacy and safety outcomes between the de-intensified experimental approach and the standard chemoradiotherapy approach.

Being tested
Nogapendekin Alfa Inbakicept (NAI), hAd5-HPV Vaccine (IBRX-042), Nab-Paclitaxel, Cisplatin, De-Intensified IMRT
Keywords
Locally Advanced HPV-Positive OPSCC, Human Papillomavirus-Associated Oropharyngeal Cancer, HPV-16, Squamous Cell Carcinoma of the Oropharynx, Chemoradiation, Cisplatin, Intensity-Modulated Radiation Therapy, De-Intensification Strategy, Neoadjuvant Therapy, Adjuvant Immunotherapy, hAd5 HPV Vaccine, ANKTIVA, Phase 2, NavDx, Head and Neck Squamous Cell Carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nogapendekin Alfa Inbakicept (NAI)Drug

    NAI 1.2 mg administered subcutaneously as part of the experimental treatment regimen.

  • hAd5-HPV Vaccine (IBRX-042)Biological

    IBRX-042 administered subcutaneously as part of the experimental treatment regimen.

  • Nab-PaclitaxelDrug

    Nab-paclitaxel 100 mg/m² administered intravenously during neoadjuvant treatment cycles.

  • CisplatinDrug

    Cisplatin 40 mg/m² administered intravenously concurrently with radiation therapy.

  • De-Intensified IMRTRadiation

    IMRT 40 Gy, delivered once daily, 5 days/week, over 4 weeks (20 total fractions)

  • Standard of Care IMRTRadiation

    SOC IMRT 70 Gy, delivered once daily, 5 days/week, over 7 weeks (35 total fractions)

Study groups in NCT07628062
Study groupRoleWhat they receive
Phase 2a, Single Arm (Safety Lead-In)ExperimentalParticipants will receive neoadjuvant nogapendekin alfa inbakicept (NAI), hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel followed by de-intensified intensity-modulated radiation therapy (IMRT) with concurrent cisplatin, and post-radiation NAI and IBRX-042 during the Phase 2a safety lead-in portion of the study.
Receives: Drug: Nogapendekin Alfa Inbakicept (NAI); Biological: hAd5-HPV Vaccine (IBRX-042); Drug: Nab-Paclitaxel; Radiation: De-Intensified IMRT
Arm AExperimentalParticipants will receive neoadjuvant nogapendekin alfa inbakicept (NAI), hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel followed by de-intensified intensity-modulated radiation therapy (IMRT) with concurrent cisplatin, and post-radiation NAI and IBRX-042.
Receives: Drug: Nogapendekin Alfa Inbakicept (NAI); Biological: hAd5-HPV Vaccine (IBRX-042); Drug: Nab-Paclitaxel; Drug: Cisplatin; Radiation: De-Intensified IMRT
Arm BActive comparatorParticipants will receive standard-of-care intensity-modulated radiation therapy (IMRT) with concurrent cisplatin for locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC).
Receives: Drug: Cisplatin; Radiation: De-Intensified IMRT; Radiation: Standard of Care IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Progression-free survival (PFS) as assessed by RECIST 1.1 criteria comparing the experimental treatment arm with the standard-of-care control arm in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC).

    Measured: Up to approximately 2 years after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start22 Jul 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion27 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a two-part Phase 2a/2 study consisting of an initial single-arm safety lead-in cohort followed by a randomized parallel-group comparison between an experimental de-intensified chemoradiation regimen and standard-of-care chemoradiation in participants with locally advanced HPV-positive OPSCC.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628062
Sponsor's protocol ID
ResQ1190-HPV
Status last verified
May 2026
First submitted
1 Jun 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nogapendekin Alfa Inbakicept (NAI), hAd5-HPV Vaccine (IBRX-042) and Nab-Paclitaxel in people with HPV-Positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by ImmunityBio, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 2 years after completion of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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