NCT03292250

Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]

Public-interest Multicenter Umbrella Trial Based on Genetic Analysis in Korean Head and Neck Cancer and Esophageal Cancer Patient - Part 1 (HNSCC)]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma

Detailed description

This study will be conducted as a part of umbrella trial by Korean Cancer Study Group. The brief scheme of this umbrella trial is as follows: R/M HNSCC 2nd line 1. PI3K inhibitor - BYL719 (from Norvatis) 2. EGFR/HER2 inhibitor - poziotinib (from Hanmi pharmaceutical) 3. FGFR inhibitor - nintedanib (from Boehringer ingelheim) 4. Cell cycle (CDK4/6) inhibitor - abemaciclib (from Lily) 5. Others- anti PD1/PD-L1 - durvalumab+/-tremelimumab (from AZ) During or after palliative 1st line platinum based chemotherapy, we will perform prescreening NGS based molecular characterization. The molecular characterization will be done by following three methods. * NGS : Agilent SureSelect Target Enrichment (245 genes) * Nanostring nCounter including immune signature * IHC : PD-L1, CD8 TIL, p16 Mutation will be analyzed by NGS, fusion and amplification will be determined by Nanostring methods, and PD-L1/p16 status will be determined by immunohistopathology. Molecular tumor board to determine characterization will be held for every patients. Once each patients have relevant genetic pathway, the patients will be allocated each treatment arm (see below figure). If the patients have no relevant genetic alteration, such a patients will allocated to durvalumab+/- tremelimumab arm regardeless of PD-L1 positivity. If the patients who allocated to poziotinib, BYL719, nintedanib, and abemaciclib experience disease progression but still meet the inclusion/ exclusion criteria for durvalumab+/- tremelimumab arm, the cross over to durvalumab+/- tremelimumab arm will be permitted. Vice versa (cross over from durvalumab+/- tremelimumab arm to another arms) is not permitted.

Conditions

• HNSCC
• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	BYL719	Patients will be instructed to take BYL719 orally at a dose of 100 mg with a glass of water once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day.
DRUG	Poziotinib	Patients will be instructed to take BYL719 orally at a dose of 12 mg once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day.
DRUG	Nintedanib	Initial dose 200 mg twice per day orally according to study protocol.
DRUG	Abemaciclib	Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day.
DRUG	Durvalumab,Tremelimumab	Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.

Timeline

• Start date: 2017-09-10
• Primary completion: 2020-03-01
• Completion: 2022-03-10
• First posted: 2017-09-25
• Last updated: 2022-03-29

Locations

1 site across 1 country: South Korea