Combining INBRX-106 with Pembrolizumab for advanced head and neck cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of the OX40 receptor agonist INBRX-106 in combination with the anti-PD-1 antibody pembrolizumab as a first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that cannot be treated with local therapies. The study is designed as a seamless phase 2/3 randomized controlled trial, comparing the combination therapy to pembrolizumab alone with a placebo in the phase 3 portion. Eligible patients must have a PD-L1 expression score of CPS ≥20 and measurable disease according to RECIST 1.1 guidelines.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of recurrent/metastatic oropharyngeal squamous cell carcinoma (OPSCC) considered incurable by local therapies.
* Has tumor PD-L1 expression with a combined proportion score (CPS) ≥1 by central testing.
* HPV-positive tumor status as assessed locally by p16 immunohistochemistry (IHC).
* Has measurable disease per RECIST 1.1 guidelines.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Has primary tumor site (any histology) of any other location than oropharynx.
* Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for R/M 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 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.
* Active or high risk of tumor-associated bleeding.
* Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• Los Angeles Cancer Network (LACN)
  Los Angeles, California, United States Recruiting
• Medical Oncology Associates of San Diego
  San Diego, California, United States Recruiting
• Sarcoma Oncology Center
  Santa Monica, California, United States Recruiting
• The Oncology Institute of Hope & Innovation
  Miami, Florida, United States Recruiting
• Mid Florida Hematology and Oncology Center
  Orange City, Florida, United States Recruiting

+39 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director - Inhibrx
• Email: clinicaltrials@inhibrx.com
• Phone: 858-500-7833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.