drugset / Trial / NCT03737968
Window of Opportunity Trial of Durvalumab (MEDI4736) or Durvalumab/Tremelimumab as Neoadjuvant Chemotherapy to Identify Immune Dynamics in Surgically Resectable Head and Neck Cancer Patients.
RandomizedSingle-groupOpen-labelTreatment
Summary
This is a phase II randomized, open label study of durvalumab with/ without tremelimumab as neoadjuvant therapy and durvalumab maintenance after SoC RTx with/without cisplatin as post-surgical adjuvant therapy in treatment naïve participants with newly diagnosed resectable LA HNSCC. The study will be conducted in conformance with Good Clinical Practices (GCP). Approximately 44 participants will be randomized in a 1:1 ratio to below two Arms
Timeline
- Start
- 2019-01-02
- Primary completion
- 2023-10
- Completion
- 2023-10
Publications
- Cha J, Kim CG, Sim NS, Kim G, Son W, Kim D, Jung Y, Hong HJ, Lee HB, Kim J, Kim J, Yoon SO, Go S, Kim J, Seong E, Baek S, Kim KH, Hong MH, Koh YW, Lee I, Kim HR. 4-1BB+ Tregs and inhibitory progenitor exhausted T cells confer resistance to anti-PD-L1 and anti-CTLA-4 combination therapy. Cell Rep Med. 2025 Oct 21;6(10):102408. doi: 10.1016/j.xcrm.2025.102408. Epub 2025 Oct 3.
- Cha J, Kim DH, Kim G, Cho JW, Sung E, Baek S, Hong MH, Kim CG, Sim NS, Hong HJ, Lee JE, Hemberg M, Park S, Yoon SO, Ha SJ, Koh YW, Kim HR, Lee I. Single-cell analysis reveals cellular and molecular factors counteracting HPV-positive oropharyngeal cancer immunotherapy outcomes. J Immunother Cancer. 2024 Jun 10;12(6):e008667. doi: 10.1136/jitc-2023-008667.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 20 mg/kg | — |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |
| Comparator | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |