drugset / Trial / NCT06295731
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
RandomizedParallel-groupDouble-blindTreatment
Summary
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.
Timeline
- Start
- 2024-05-14
- Primary completion
- 2029-05
- Completion
- 2029-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INBRX-106 | Unknown | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |