drugset / Trial / NCT03292250
Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]
Phase 2
Completed
180 enrolled
Seoul National University Hospital
Chungnam National University Hospital · collabKorean Cancer Study Group · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma
Timeline
- Start
- 2017-09-10
- Primary completion
- 2020-03-01
- Completion
- 2022-03-10
Publications
- Park JH, Ahn HK, Kim HR, Kim S, Park KU, Yun T, Kim HJ, Lee SC, Cho SH, Park SG, Keam B, Yun HJ. Exploratory Biomarker Analysis of Abemaciclib in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma With Dysregulated CDK4/6 Pathway. Head Neck. 2026 Jun;48(6):1547-1558. doi: 10.1002/hed.70165. Epub 2026 Jan 13.
- Keam B, Hong MH, Shin SH, Heo SG, Kim JE, Ahn HK, Lee YG, Park KU, Yun T, Lee KW, Kim SB, Lee SC, Kim MK, Cho SH, Oh SY, Park SG, Hwang S, Nam BH, Kim S, Kim HR, Yun HJ; KCSG TRIUMPH Investigators. Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial. J Clin Oncol. 2024 Feb 10;42(5):507-517. doi: 10.1200/JCO.22.02786. Epub 2023 Sep 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 200 mg | Oral |
| Subject | Alpelisib | Small molecule | 100 mg | Oral |
| Subject | Durvalumab | Monoclonal antibody | 750 mg | Intravenous |
| Subject | Nintedanib | Small molecule | 200 mg | Oral |
| Subject | Poziotinib | Small molecule | — | Oral |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |