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.
Volunteer to participate and sign the informed consent form.
Has a histologically confirmed diagnosis of endometrial carcinoma (EC). Has Documented evidence of advanced, recurrent or metastatic EC and are not candidates for curative surgery or radiation.
Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC.
Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blind Independent Imaging Review Committee (BIRC).
Previous lab results showed dMMR or MSI-H.
Participate in the clinical trials of other investigational drugs within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy or targeted therapy.
The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level.
Recieved major surgery with 28 days before the first medication or has serious nonhealing wound, ulcer, or bone fracture at screening.
Factorial
Envafolimab+Lenvatinib
DrugEnvafolimab: 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
DrugEnvafolimab: 400mg envafolimab was administered once in D1 and D15 of the first treatment cycle and once in D1 of each subsequent 28 day cycle.
ORR 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.
The duration of response (DoR）
Disease control rate (DCR)
Time to response (TTR)
Progression-free survival (PFS)
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