Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer

January 30, 2024 updated by: 3D Medicines (Sichuan) Co., Ltd.

An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yunong Gao
    • Chongqing
      • Chongqing, Chongqing, China, 40030
        • Recruiting
        • Chongqing University Three Gorges Hospital
        • Contact:
        • Principal Investigator:
          • Wenhua Ran
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian cancer hospital
        • Contact:
        • Principal Investigator:
          • Qin Xu
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Bingzhong Zhang
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yanlin Luo
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital of China
        • Contact:
        • Principal Investigator:
          • Guiling Li
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • :Hubei Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yi Huang
    • Hunan
      • Changsha, Hunan, China, 200001
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • Chun Fu
      • Yueyang, Hunan, China, 414604
        • Recruiting
        • Yueyang Center Hospital
        • Contact:
        • Principal Investigator:
          • Jianbing Hu
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Recruiting
        • :Nanjing Maternity and Child Health Care Hospital
        • Contact:
        • Principal Investigator:
          • Xuemei Jia
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341005
        • Recruiting
        • Ganzhou Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xiuhong Wu
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning cancer hospital
        • Contact:
        • Principal Investigator:
          • Danbo Wang
    • Shandong
      • Jinan, Shandong, China, 250063
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Youzhong Zhang
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Qingshui Li
      • Linyi, Shandong, China, 276002
        • Recruiting
        • :Linyi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xiumin Li
      • Tai'an, Shandong, China, 271099
        • Recruiting
        • Tai'an Center Hospital
        • Contact:
        • Principal Investigator:
          • Zhaofeng Zhu
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Xiaohua Wu
    • Tianjing
      • Tianjing, Tianjing, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute＆Hospital
        • Contact:
        • Principal Investigator:
          • Ke Wang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Recruiting
        • Cancer Hospital of The University of Chinese Academy of Sciences
        • Contact:
        • Principal Investigator:
          • Xiang Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 factor, blood transfusion or platelet therapy was given within 14 days before the first study drug treatment).
  8. 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.
  9. Females of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug.

Exclusion Criteria:

  1. Previous lab results showed dMMR or MSI-H.
  2. 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.
  3. The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level.
  4. Recieved major surgery with 28 days before the first medication or has serious nonhealing wound, ulcer, or bone fracture at screening.
  5. 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.
  6. Uncontrolled blood pressure (BP) with or without antihypertensive medications, defined as BP >150/90 mmHg.
  7. Uncontrolled or major Cardio-cerebral vascular disease.
  8. 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.
  9. Subjects who need to use corticosteroids (> 10 mg/day prednisone equivalent dose) for systemic therapy within 14 days before the study drug is administered.
  10. Has received a live-virus vaccination within 28 days of planned treatment start or plan to reveived a live-virus vaccination during the study.
  11. Has current or suspected (non-infectious) pneumonitis.
  12. Active infection (any infection requiring systemic treatment).
  13. Has active Hepatitis B or C.
  14. Is positive for Human Immunodeficiency Virus (HIV).
  15. Has uncontrolled pericardial effusion, pleural effusion or ascites.
  16. Has symptomatic/active brain metastasis or meningeal carcinomatosis; for patients with brain metastases who have previously received treatment, if the clinical and imaging evidence does not indicate disease progression within 4 weeks before the first study drug treatment, and 2 weeks before the first administration There is no need to receive corticosteroid treatment and can be considered for inclusion.
  17. Suffered from other known malignant tumors within 5 years before enrollment (except for treated skin basal cell carcinoma, skin squamous cell carcinoma and/or carcinoma in situ after radical resection).
  18. Hypersensitivity to either of the study drug or its components.
  19. Females who are pregnant or breastfeeding and who refuse to use a highly effective method of contraception throughout the entire study period, and for 6 months after the last dose of study drug;
  20. According to the judgement of the investigators, there are other factors indicate that the subject should not be enrolled.
  21. Has received prior treatment with any treatment targeting VEGF-directed angiogenesis.
  22. Has radiographic evidence of major blood vessel invasion/infiltration.
  23. Has a history of hypertensive crisis or hypertensive encephalopathy.
  24. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
  25. Has a history of serious bleeding disease within 6 months prior to the first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Envafolimab + Lenvatinib
Subjects 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.
Drug: Envafolimab+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.
Experimental: Envafolimab
Subjects receive envafolimab once on Day 1 and 15 of the first cycle and at the beginning of each subsequent 4 week treatment cycle D1.
Drug: Envafolimab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR of Envafolimab alone or with Lenvatinib
Time Frame: Up to approximately 24 months
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 Outcome Measures

Outcome Measure
Time Frame
The duration of response (DoR）
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Disease control rate (DCR)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Time to response (TTR)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Progression-free survival (PFS)
Time Frame: Up to approximately 24 months
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
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3D Medicines (Sichuan) Co., Ltd.

Investigators

  • Principal Investigator: xiaohua Wu, Dr, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KN035-CN-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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