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

Sponsor
3D Medicines (Sichuan) Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05112991
Collaborator
(none)
108
Enrollment
19
Locations
2
Arms
30.9
Anticipated Duration (Months)
5.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
This study is an open-label, two-arm study, without randomization and blindingThis study is an open-label, two-arm study, without randomization and blinding
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
Actual Study Start Date :
Mar 4, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. ORR of Envafolimab alone or with Lenvatinib [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.

Secondary Outcome Measures

  1. The duration of response (DoR） [Up to approximately 24 months]

  2. Disease control rate (DCR) [Up to approximately 24 months]

  3. Time to response (TTR) [Up to approximately 24 months]

  4. Progression-free survival (PFS) [Up to approximately 24 months]

  5. To evaluate the overall survival (OS) in in subjects with advance endometrial cancer [Up to approximately 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

  1. 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).

  2. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  3. Life expectancy of 12 weeks or more.

  4. 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).

  5. 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.

  6. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142
2 Chongqing University Three Gorges Hospital Chongqing Chongqing China 40030
3 Fujian Cancer Hospital Fuzhou Fujian China 350014
4 Sun Yat-Sen Memorial Hospital Guangzhou Guangdong China 510120
5 Henan Cancer Hospital Zhengzhou Henan China 450003
6 Wuhan Union Hospital of China Wuhan Hubei China 430022
7 :Hubei Cancer Hospital Wuhan Hubei China 430079
8 The Second Xiangya Hospital of Central South University Changsha Hunan China 200001
9 Yueyang Center Hospital Yueyang Hunan China 414604
10 :Nanjing Maternity and Child Health Care Hospital Nanjing Jiangsu China 210004
11 Ganzhou Cancer Hospital Ganzhou Jiangxi China 341005
12 Liaoning Cancer Hospital Shenyang Liaoning China 110801
13 Qilu Hospital of Shandong University Jinan Shandong China 250063
14 Shandong Cancer Hospital Jinan Shandong China 250117
15 :Linyi Cancer Hospital Linyi Shandong China 276002
16 Tai'an Center Hospital Tai'an Shandong China 271099
17 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032
18 Tianjin Medical University Cancer Institute&Hospital Tianjing Tianjing China 300181
19 Cancer Hospital of The University of Chinese Academy of Sciences Hangzhou Zhejiang China 310005

Sponsors and Collaborators

  • 3D Medicines (Sichuan) Co., Ltd.

Investigators

  • Principal Investigator: xiaohua Wu, Dr, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
3D Medicines (Sichuan) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05112991
Other Study ID Numbers:
  • KN035-CN-011
First Posted:
Nov 9, 2021
Last Update Posted:
Jun 23, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 3D Medicines (Sichuan) Co., Ltd.
endometrial cancer
Additional relevant MeSH terms:
Endometrial Neoplasms
Lenvatinib

Study Results

No Results Posted as of Jun 23, 2022