Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-30 @ 12:09 AM
Study NCT ID:
NCT03292250
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2017-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Public-interest Multicenter Umbrella Trial Based on Genetic Analysis in Korean Head and Neck Cancer and Esophageal Cancer Patient - Part 1 (HNSCC)]
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: