Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma
Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
Seoul National University Hospital
Seoul, South Korea
Response rate (RR)
RECIST1.1
Time frame: 24months
•Progression-Free Survival (PFS)
Disease progression is assessed by RECIST 1.1.
Time frame: 24months
•Overall Survival (OS)
Overall Survival is defined as the time from first dose to death due to any cause. Through the follow-up within 30 days after study completion or termination of the last subject, death and date of death will be checked for subject alive during treatment period
Time frame: 24months
•Toxicity
number of patients with treatment-related AE as assessed by NCI CTCAE version 4.03
Time frame: 24months
•biomarker
NGS, nanostring technology
Time frame: 24months
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