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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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-Paclitaxel — DRUG
  Nab-paclitaxel 100 mg/m² administered intravenously during neoadjuvant treatment cycles.
• Cisplatin — DRUG
  Cisplatin 40 mg/m² administered intravenously concurrently with radiation therapy.
• De-Intensified IMRT — RADIATION
  IMRT 40 Gy, delivered once daily, 5 days/week, over 4 weeks (20 total fractions)
• Standard of Care IMRT — RADIATION
  SOC IMRT 70 Gy, delivered once daily, 5 days/week, over 7 weeks (35 total fractions)

Study Details

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.

Key Dates

First listed

Jun 4, 2026

Start date

Jul 22, 2026

Status verified

May 2026

Primary completion

Dec 31, 2030

Completion

Jun 27, 2031

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2a, Single Arm (Safety Lead-In)
  Participants 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.
• Experimental: Arm A
  Participants 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.
• Active Comparator: Arm B
  Participants will receive standard-of-care intensity-modulated radiation therapy (IMRT) with concurrent cisplatin for locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC).

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 2 years after completion of treatment ]

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