Study on INBRX-106 and Pembrolizumab for First-line Treatment of Advanced Head and Neck Cancer with High PD-L1 Levels

Sponsor: Inhibrx Biosciences, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06295731

Provider View

This clinical trial is testing a new combination of drugs, INBRX-106 and pembrolizumab, to see if they are more effective than pembrolizumab alone in treating advanced head and neck cancer that cannot be cured with local treatments and has high levels of PD-L1.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new drug combination, INBRX-106 and pembrolizumab, compared to pembrolizumab alone in patients with advanced head and neck squamous cell carcinoma (HNSCC) that cannot be treated with surgery or radiation. The study focuses on patients whose cancer shows high levels of a protein called PD-L1, which is associated with the cancer's ability to evade the immune system.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or metastatic head and neck squamous cell carcinoma that cannot be cured with local treatments.
  • Cancer must show high levels of PD-L1 (CPS ≥20) based on a lab test.
  • Must have results from HPV testing for oropharyngeal cancer.
  • Have measurable cancer according to specific medical guidelines.
  • Primary cancer location must be in the oral cavity, oropharynx, hypopharynx, or larynx.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and must not be breastfeeding.
  • Men and women of childbearing potential must agree to use effective contraception or abstain from sex during the study.

Exclusion Criteria

  • Cancer located in the nasopharynx, salivary glands, or an unknown primary site.
  • Have received previous systemic therapy for advanced head and neck cancer, unless it was completed over 6 months ago as part of a treatment plan aimed at curing the disease, and the cancer did not return within 6 months.
  • Have active cancer spread to the brain or spinal cord.
  • Have an immune system deficiency or are taking medications that suppress the immune system within 7 days before starting the study treatment.
  • Have rapidly progressing cancer or cancer that poses a high risk of bleeding or severe pain.
  • Have a history of immune-related diseases that required treatment in the past 2 years, except for hormone replacement therapy.

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