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
- Aberdeen, Cambridge, Chelsea, Manchester, Newcastle upon Tyne, Northwood, Norwich, and Sutton, United KingdomSee the 8 sites
- Phase
- Phase 2/3
Where in United Kingdom
- NHS Grampian - Aberdeen Royal InfirmaryAberdeen, United KingdomNo longer taking part
- Addenbrooke's HospitalCambridge, United KingdomNo longer taking part
- The Royal Marsden NHS Foundation Trust, ChelseaChelsea, United KingdomNo longer taking part
- The Christie NHS Foundation TrustManchester, United KingdomNo longer taking part
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Northern Centre for Cancer Care, Freeman HospitalNewcastle upon Tyne, United KingdomNo longer taking part
- Mount Vernon Cancer CentreNorthwood, United KingdomNo longer taking part
- Norwich and Norfolk University HospitalNorwich, United KingdomNo longer taking part
- The Royal Marsden NHS Foundation Trust - SuttonSutton, United KingdomNo 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.