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

NCT07628062 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-04

No results posted yet for this study

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.

Conditions

  • HPV-Positive Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
  • Head and Neck Cancer

Interventions

DRUG

Nogapendekin Alfa Inbakicept (NAI)

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

BIOLOGICAL

hAd5-HPV Vaccine (IBRX-042)

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

DRUG

Nab-Paclitaxel

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

DRUG

Cisplatin

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

RADIATION

De-Intensified IMRT

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

RADIATION

Standard of Care IMRT

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

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-22
Primary Completion
2030-12-31
Completion
2031-06-27
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628062 on ClinicalTrials.gov