Ordastobart (INBRX-106) Add-on to Pembrolizumab in 1L HPV+ PD-L1+ R/M OPSCC (HexAgon-HN)
NCT06295731 · HexAgon-HN Phase 2/3Recruiting
- Lead sponsor
- Inhibrx Biosciences, Inc (Industry)
- Enrollment
- 450 (estimated)
- Start date
- 14 May 2024
- Primary completion
- Dec 2029 (estimated)
- Study completion
- 1 May 2031
- Last update posted
- 28 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 2
Interventions
- INBRX-106 Drug
- Pembrolizumab Drug
Conditions and primary outcome
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- HPV Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC)
Primary outcome
Phase 2: Objective Response Rate by investigator (ORRinv) (From randomization to progressive disease (PD) or death (up to 1 year)); Phase 3: Progression-Free Survival by Investigator (PFSinv) (From randomization to PD or death (up to 4 years)); Phase 3: Overall Survival (OS) (From randomization until death from any cause (up to 4 years))
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06295731.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06295731 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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