Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
1 other identifier
interventional
108
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedStudy Start
First participant enrolled
March 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 25, 2026
March 1, 2026
4.7 years
October 28, 2021
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to approximately 24 months
Secondary Outcomes (5)
The duration of response (DoR）
Up to approximately 24 months
Disease control rate (DCR)
Up to approximately 24 months
Time to response (TTR)
Up to approximately 24 months
Progression-free survival (PFS)
Up to approximately 24 months
To evaluate the overall survival (OS) in in subjects with advance endometrial cancer
Up to approximately 24 months
Study Arms (2)
Envafolimab + Lenvatinib
EXPERIMENTALSubjects receive lenvatinib daily and envafolimab once on Day 1 and 15 of the first cycle and at the beginning of each subsequent 4 week treatment cycle D1.
Envafolimab
EXPERIMENTALSubjects receive envafolimab once on Day 1 and 15 of the first cycle and at the beginning of each subsequent 4 week treatment cycle D1.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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).
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of 12 weeks or more.
- Sufficient organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 14 days before the first study drug treatment).
- Archival tumor tissue or a newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis. Tissue samples need to be from lesions that have not received local radiotherapy.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug.
You may not qualify if:
- 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.
- Has received prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Uncontrolled blood pressure (BP) with or without antihypertensive medications, defined as BP \>150/90 mmHg.
- Uncontrolled or major Cardio-cerebral vascular disease.
- Have active, or have had autoimmune diseases or risks that may recur. However, subjects required only replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) or with skin diseases that do not require systemic treatmentare are allowed to be included.
- Subjects who need to use corticosteroids (\> 10 mg/day prednisone equivalent dose) for systemic therapy within 14 days before the study drug is administered.
- Has received a live-virus vaccination within 28 days of planned treatment start or plan to reveived a live-virus vaccination during the study.
- Has current or suspected (non-infectious) pneumonitis.
- Active infection (any infection requiring systemic treatment).
- Has active Hepatitis B or C.
- Is positive for Human Immunodeficiency Virus (HIV).
- Has uncontrolled pericardial effusion, pleural effusion or ascites.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 40030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Wuhan Union Hospital of China
Wuhan, Hubei, 430022, China
:Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 200001, China
Yueyang Center Hospital
Yueyang, Hunan, 414604, China
:Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004, China
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, 341005, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250063, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
:Linyi Cancer Hospital
Linyi, Shandong, 276002, China
Tai'an Center Hospital
Tai’an, Shandong, 271099, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Tianjin Medical University Cancer Institute&Hospital
Tianjing, Tianjing, 300181, China
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, 310005, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xiaohua Wu, Dr
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 9, 2021
Study Start
March 4, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share