Tests ordastobart with pembrolizumab in HPV-positive throat cancer that has returned or spread
Tests ordastobart added to pembrolizumab in adults with HPV-positive throat cancer.
Plain-language title generated from the registry record
Registry title: Ordastobart (INBRX-106) Add-on to Pembrolizumab in 1L HPV+ PD-L1+ R/M OPSCC (HexAgon-HN)
Key facts
- Where
- Bucharest, Cluj-Napoca, Cluj, and Craiova, RomaniaSee the 4 sites
- Phase
- Phase 2/3
Where in Romania
- ARENSIA Clinic Oncology Institute BucharestBucharest, RomaniaNo longer taking part
- Arensia Exploratory Medicine S.R.L in collaboration with "Prof. Dr. Ion Chiricuta" Oncology InstituteCluj-Napoca, Cluj, RomaniaNo longer taking part
- Sc Centrul de Oncologie Sf Nectarie SrlCraiova, RomaniaNo longer taking part
- SC Oncolab SRLCraiova, RomaniaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Inhibrx Biosciences, Inc
- Trial code
- NCT06295731
- Record updated
- 28 October 2026
- Original description
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with recurrent or metastatic (R/M) HPV-positive Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) expressing PD-L1.Read full original descriptionShow less
A Phase 2/3, Randomized Study of Ordastobart (INBRX-106) Plus Pembrolizumab vs Pembrolizumab as First-Line Treatment for Patients With Recurrent or Metastatic HPV-positive Oropharyngeal Squamous Cell Carcinoma Expressing PD-L1 (HexAgon-HN)
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with recurrent or metastatic (R/M) HPV-positive Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) expressing PD-L1.
Inclusion: 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: 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 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; Has primary tumor site (any histology) of any other location than oropharynx; Has clinically active central nervous system metastases and/or carcinomatous meningitis.