RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-05-14

Study Completion:2029-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06295731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Study Director - Inhibrx

CONTACT

858-500-7833

clinicaltrials@inhibrx.com

Principal Investigator

Clinical Lead

STUDY_DIRECTOR

Inhibrx Biosciences, Inc

Study Locations (Sites)

City of Hope Medical Center

Duarte, California, 91010

United States

Los Angeles Cancer Network (LACN)

Los Angeles, California, 91204

United States

Sutter Health

Sacramento, California, 95816

United States

Sarcoma Oncology Center

Santa Monica, California, 90403

United States

The Oncology Institute of Hope & Innovation

Miami, Florida, 33169

United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763

United States

Norton Cancer Institute

Louisville, Kentucky, 40202

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Washington University St. Louis

Saint Louis, Missouri, 63110

United States

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

Billings, Montana, 59102

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130

United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505

United States

CHRISTUS Spohn Cancer Center

Corpus Christi, Texas, 78404

United States

Collaborators and Investigators

Sponsor: Inhibrx Biosciences, Inc

Clinical Lead, STUDY_DIRECTOR, Inhibrx Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-14

Study Completion Date2029-05

Study Record Updates

Study Start Date2024-05-14

Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma (HNSCC)