RecruitingPhase 2NCT05112991

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

Sponsor

3D Medicines (Sichuan) Co., Ltd.

Enrollment

108 participants

Start Date

Mar 4, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Endometrial Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing two drugs — envafolimab (an immunotherapy) alone or combined with lenvatinib (a targeted therapy) — in people with advanced endometrial (uterine) cancer that has spread or come back after prior chemotherapy. The goal is to find out if this combination is safe and effective. **You may be eligible if...** - You have been diagnosed with advanced, recurrent, or metastatic endometrial cancer - You are not a candidate for curative surgery or radiation - Your cancer has stopped responding to standard platinum-based chemotherapy - Your cancer can be measured on scans - You have a performance status of 0 or 1 (able to carry out daily activities with minimal restriction) - You are expected to live at least 12 weeks - You are 18 or older **You may NOT be eligible if...** - You still have active, untreated brain metastases - You have significant uncontrolled heart disease - You have severe liver or kidney problems - You are pregnant or breastfeeding - You have autoimmune conditions requiring systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnvafolimab+Lenvatinib

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.

DRUGEnvafolimab

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.

Locations(19)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

:Hubei Cancer Hospital

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Yueyang Center Hospital

Yueyang, Hunan, China

:Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

:Linyi Cancer Hospital

Linyi, Shandong, China

Tai'an Center Hospital

Tai’an, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute&Hospital

Tianjing, Tianjing, China

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05112991

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