Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Siao-Yi Wang, MD, PhD (ucdavis)

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

Lead Scientist at University of California Health

  • Siao-Yi Wang, MD, PhD (ucdavis)
    Assistant Professor, MED: Int Med Hematology/Oncology, School of Medicine

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