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

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 10, 2017

Primary Completion Date

March 1, 2020

Study Completion Date

March 10, 2022

Conditions
HNSCCHead and Neck Neoplasms
Interventions
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.

Trial Locations (1)

110-744

Seoul National University Hospital, Seoul

All Listed Sponsors
collaborator

Korean Cancer Study Group

OTHER

collaborator

Chungnam National University Hospital

OTHER

lead

Seoul National University Hospital

OTHER

NCT03292250 - Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] | Biotech Hunter | Biotech Hunter