Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Head and Neck Neoplasms
HNSCC
Squamous Cell Carcinoma of Head and Neck

Clinical Trial Details

NCT number	NCT03292250
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	September 10, 2017
Completion date	March 10, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms