Head and Neck Squamous Cell Carcinoma study: INBRX-106 vs Pembrolizumab
Official title Ordastobart (INBRX-106) Add-on to Pembrolizumab in 1L HPV+ PD-L1+ R/M OPSCC (HexAgon-HN)
ClinicalTrials.gov ID: NCT06295731
What this study is testing
What is INBRX-106?
INBRX-106 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for head and neck squamous cell carcinoma (hnscc).
Also referred to as Hexavalent OX40 agonist antibody, Ordastobart.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding ordastobart to pembrolizumab improves how well the treatment works and how safe it is for people with HPV‑positive head and neck cancer.
- Who it's for
- You may be able to join if you have recurrent or metastatic HPV‑positive oropharyngeal cancer and are starting first‑line therapy.
- What's involved
- You will receive the drug ordastobart together with pembrolizumab. In phase 3 you will also get a pretend treatment instead of ordastobart. You will have regular visits and blood tests to check safety and effectiveness.
- Time commitment
- The study lasts about 2 years, with visits every few weeks during treatment and later check‑ins to monitor progress.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has histologically or cytologically confirmed diagnosis of recurrent/metastatic oropharyngeal squamous cell carcinoma (OPSCC) considered incurable by...
- 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.
You likely can't join if
- 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...
- 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...
- Rapidly progressing disease.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Billings, Montana, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- Santa Fe, New Mexico, United States
- Chapel Hill, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
- Corpus Christi, Texas, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Los Angeles, California, United States; San Diego, California, United States; Santa Monica, California, United States; Miami, Florida, United States; Orange City, Florida, United States and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.