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
Study ID
NCT03292250
Phase
PHASE2
Status
Completed

Conditions

  • HNSCC
  • Head and Neck Neoplasms

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BYL719 — DRUG
    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.
  • Poziotinib — DRUG
    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.
  • Nintedanib — DRUG
    Initial dose 200 mg twice per day orally according to study protocol.
  • Abemaciclib — DRUG
    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.
  • Durvalumab,Tremelimumab — DRUG
    Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.

Study Details

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

Key Dates

Start date
Sep 10, 2017
Status verified
Mar 2022
Primary completion
Mar 1, 2020
Completion
Mar 10, 2022

Study Design

Enrollment
180 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm1: BYL719
    Experimental: BYL719 BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds.
  • Experimental: Arm2: Poziotinib
    Experimental:Poziotinib Poziotinib is a pan-HER tyrosine kinase inhibitor.(oral class)
  • Experimental: Arm3: Nintedanib
    Nintedanib is a potent small molecule triple receptor tyrosine kinase inhibitor (PDGFR, FGFR 1-3,VEGFR 1-3 ,VEGFR- 2) is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumour vasculature.(oral class)
  • Experimental: Arm4: Abemaciclib
    Abemaciclib represents a selective and potent small molecule CDK4 and CDK6 dual inhibitor with broad antitumor activity in preclinical pharmacology models.(oral class)
  • Experimental: Arm5: Durvalumab,Tremelimumab
    Durvalumab is a human immunoglobulin (Ig) G1 kappa (IgG1κ) monoclonal antibody (mAb) that blocks the interaction of PD-L1 with PD-1 on T-cells and CD80 on immune cells and is engineered to reduce antibody-dependent cell-mediated cytotoxicity.(IV class) Tremelimumab is specific for human CTLA-4; cluster of differentiation a cell surface receptor that is expressed primarily on activated T cells and acts to inhibit their activation.(IV class)

Primary Outcome Measure

Disease control rate (DCR) [ Time Frame: 24 months ]

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