This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab alone or with lenvatinib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Envafolimab: 400mg envafolimab was administered once in D1 and D15 of the first treatment cycle and once in D1 of each subsequent 28 day cycle. Lenvatinib: the recommended Phase 2 dose (RP2D) orally 20mg QD during each 28-day cycle.
Envafolimab: 400mg envafolimab was administered once in D1 and D15 of the first treatment cycle and once in D1 of each subsequent 28 day cycle.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGORR of Envafolimab alone or with Lenvatinib
The ORR (either confirmed complete response \[CR\] or partial response \[PR\]) based on RECIST 1.1 will be determined in participants who have measurable disease at study entry.
Time frame: Up to approximately 24 months
The duration of response (DoR)
Time frame: Up to approximately 24 months
Disease control rate (DCR)
Time frame: Up to approximately 24 months
Time to response (TTR)
Time frame: Up to approximately 24 months
Progression-free survival (PFS)
Time frame: Up to approximately 24 months
To evaluate the overall survival (OS) in in subjects with advance endometrial cancer
Time frame: Up to approximately 24 months
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Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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RECRUITING...and 9 more locations