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Combining INBRX-106 with Pembrolizumab for advanced head and neck cancer treatment

A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN)

Phase2; Phase3 Interventional Inhibrx Biosciences, Inc · NCT06295731

This study is testing whether combining a new treatment called INBRX-106 with pembrolizumab can help people with advanced head and neck cancer that can't be treated with local therapies.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment410 (estimated)
Ages18 Years and up
SexAll
SponsorInhibrx Biosciences, Inc Industry-sponsored
Drugs / interventionsimmunotherapy, pembrolizumab
Locations39 sites (Duarte, California and 38 other locations)
Trial IDNCT06295731 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of the OX40 receptor agonist INBRX-106 in combination with the anti-PD-1 antibody pembrolizumab as a first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that cannot be treated with local therapies. The study is designed as a seamless phase 2/3 randomized controlled trial, comparing the combination therapy to pembrolizumab alone with a placebo in the phase 3 portion. Eligible patients must have a PD-L1 expression score of CPS ≥20 and measurable disease according to RECIST 1.1 guidelines.

Who should consider this trial

Good fit: Ideal candidates include patients with metastatic or recurrent HNSCC that is not amenable to local therapies and who have a PD-L1 CPS score of 20 or higher.

Not a fit: Patients with HNSCC that is curable by local therapies or those without sufficient PD-L1 expression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced head and neck cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
* Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis.
* Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing.
* Has measurable disease per RECIST 1.1 guidelines.
* Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx.
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding.
* Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception.

Exclusion Criteria:

* Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.
* Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.

  * Prior systemic therapy completed \>6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.
* Has clinically active central nervous system metastases and/or carcinomatous meningitis.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.
* Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

Where this trial is running

Duarte, California and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Head and Neck Squamous Cell CarcinomaOX40 receptor agonistPD-L1 positivePembrolizumabImmunotherapyChemotherapy-freeHNSCCHead and Neck Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.