Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.

Official Title

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)

Keywords

Head and Neck Squamous Cell Carcinoma (HNSCC), OX40 receptor agonist, PD-L1 positive, Pembrolizumab, Immunotherapy, Chemotherapy-free, HNSCC, Head and Neck Cancer, Keytruda, Oropharyngeal cancer, Hypopharyngeal cancer, Laryngeal cancer, Oral cancer, INBRX-106, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, INBRX-106 plus pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • Sarcoma Oncology Center accepting new patients
    Santa Monica California 90403 United States
  • Medical Oncology Associates of San Diego accepting new patients
    San Diego California 92123 United States
  • Los Angeles Cancer Network (LACN) accepting new patients
    Los Angeles California 91204 United States
  • Sutter Health accepting new patients
    Sacramento California 95816 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Inhibrx Biosciences, Inc
ID
NCT06295731
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 410 study participants
Last Updated