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)
Brief Summary

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

Detailed Description

Not Provided

Recruiting
Head and Neck Squamous Cell Carcinoma (HNSCC)

Drug: INBRX-106

INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)
Other Name: Hexavalent OX40 agonist antibody

Drug: Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)
Other Name: Keytruda

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
United States
Locations

City of Hope Medical Center
Duarte, California, United States

Los Angeles Cancer Network (LACN)
Los Angeles, California, United States

Sutter Health
Sacramento, California, United States

Medical Oncology Associates of San Diego
San Diego, California, United States

Sarcoma Oncology Center
Santa Monica, California, United States

The Oncology Institute of Hope & Innovation
Miami, Florida, United States

Mid Florida Hematology and Oncology Center
Orange City, Florida, United States

Cleveland Clinic Florida, The Maroone Cancer Center
Weston, Florida, United States

University of Illinois Cancer Center
Chicago, Illinois, United States

Norton Cancer Institute
Louisville, Kentucky, United States

Massachusetts General Hospital
Boston, Massachusetts, United States

Karmanos Cancer Institute
Detroit, Michigan, United States

Washington University St. Louis
Saint Louis, Missouri, United States

Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana
Billings, Montana, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States

Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States

Oklahoma University Stephenson Cancer Center
Oklahoma City, Oklahoma, United States

Oregon Health & Science University
Portland, Oregon, United States

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States

CHRISTUS Spohn Cancer Center
Corpus Christi, Texas, United States

IOB Hospital Quiron Salud Barcelona
Barcelona, Gracia, Spain

Contacts

Study Director - Inhibrx
858-500-7833
clinicaltrials@inhibrx.com

Clinical Lead, Study Director
Inhibrx Biosciences, Inc

Inhibrx Biosciences, Inc
NCT Number
Keywords
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
MeSH Terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab