Head and Neck Neoplasms Clinical Trial
Official title:
A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy
Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma (FGFR inhibitor, CDK4/6 inhibitor, pan HER inhibitor, PI3K inhibitor, PD1/PD-L1 inhibitor)
This study will be conducted as a treatment arm 4 of the umbrella clinical
trial.(NCT03292250)
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
The present trial will investigate the efficacy and safety of abemaciclib in patients with
recurrent or metastatic HPV (-) HNSCC with genetic alterations of cell cycle pathway who
failed to platinum-based therapy. We will also evaluate feasibility and the effect on
decision making of next generation sequencing of HNSCC.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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||
Recruiting |
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Phase 2 | |
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Completed |
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Phase 2 |