INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Head and Neck Squamous Cell Carcinoma (HNSCC)

In brief

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.

Key facts

Study ID

NCT06295731

Run by

Inhibrx Biosciences, Inc

People needed

410

Starts

2024-05-14

Expected to finish

2029-05-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Los Angeles Cancer Network (LACN) — Los Angeles, California, United States
• UC Davis — Sacramento, California, United States
• Medical Oncology Associates of San Diego — San Diego, California, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• ChristianaCare Health Services — Newark, Delaware, United States
• University of Florida UF Health Cancer Center — Gainesville, Florida, 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 — St 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
• VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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