Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06295731

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Neoplasms Laryngeal Diseases Laryngeal Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INBRX-106

Drug

INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)

Other names: Hexavalent OX40 agonist antibody

Pembrolizumab

Drug

Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)

Other names: Keytruda

Primary outcomes

  1. Phase 2: Objective Response Rate (ORR)

    Time frame: up to 6 months

    ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  2. Phase 3: Progression-Free Survival (PFS)

    Time frame: From randomization to first occurrence of progressive disease (PD) or death (up to 4 years)

    PFS is defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST v 1.1, or death from any cause (whichever occurs first).

  3. Phase 3: Overall Survival (OS)

    Time frame: From randomization until death from any cause (up to 4 years)

    OS is the time from randomization to death due to any cause

Secondary outcomes

  1. Phase 3: Objective Response Rate (ORR)

    Time frame: From randomization until treatment discontinuation (up to 2 years)

    ORR is defined as the proportion of patients with a CR or PR on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  2. Duration of Response (DOR)

    Time frame: From the first occurrence of a documented objective response to PD or death (up to 4 years)

    DOR is defined as the time from the first occurrence of a documented objective response to PD, as determined by the Investigator according to RECIST v1.1, or death from any cause (whichever occurs first)

  3. Clinical Benefit Rate (CBR)

    Time frame: From randomization until treatment discontinuation (up to 2 years)

    CBR is defined as the proportion of patients with stable disease (SD) for ≥12 weeks or a CR or PR, as determined by the Investigator according to RECIST v1.1.

  4. Phase 3: Time to Chemotherapy (TTCtx)

    Time frame: From randomization until the start of chemotherapy or death (up to 4 years)

    TTCtx is defined as the time from randomization until the start date of chemotherapy or death from any cause (whichever occurs first).

  5. Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference

    Time frame: From randomization until treatment discontinuation (up to 2 years)

    TTCD in pain presence and interference is defined as the time from randomization to the first documentation of ≥10-point increase in pain score, as determined using the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) questionnaire

  6. TTCD in physical functioning (PF)

    Time frame: From randomization until treatment discontinuation (up to 2 years)

    TTCD in PF is defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the Quality of Life-Core 30 (EORTC QLQ-C30) linearly transformed PF scale score.

  7. TTCD in role functioning (RF)

    Time frame: From randomization until treatment discontinuation (up to 2 years)

    TTCD in RF is defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the Quality of Life-Core 30 (EORTC QLQ-C30) linearly transformed RF scale score.

  8. TTCD in Global Health Status/quality of life (GHS/QoL)

    Time frame: From randomization until treatment discontinuation (up to 2 years)

    TTCD in GHS/QoL is defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the Quality of Life-Core 30 (EORTC QLQ-C30) linearly transformed GHS/QoL scale score.

  9. Incidence and severity of Adverse Events (AEs)

    Time frame: Up to approximately 24 months

    Incidence will be reported as the number of participants with at least one adverse event, with severity determined according to the National Cancer Institute Criteria for Adverse Events, version 5 (NCI CTCAE v 5.0)

  10. Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters

    Time frame: Up to approximately 24 months

    Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature. Clinical laboratory parameter include hematology and biochemistry tests over the course of the study.

Sponsors and collaborators

Lead sponsor

Inhibrx Biosciences, Inc

Industry

Registry information

Official study 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)

Acronym: HexAgon-HN

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 6, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.