Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Volunteer to participate and sign the informed consent form. 2. 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. 3. Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC. Note: If recurrence occurs during adjuvant/neoadjuvant therapy or within 12 months after completion, adjuvant/neoadjuvant therapy is considered to be the first-line treatment for advanced disease. There is no restriction regarding prior hormonal therapy. 4. 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). 5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy of 12 weeks or more. 7. Sufficient organ and bone marrow function (no hematopoietic growth