Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer

An Open, Single-arm Clinical Study of Envafolimab, Lenvatinib Combined With VP-16 in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer，Primary Fallopian Tube Cancer and Primary Peritoneal Carcinoma

This study is a single-arm, open-label, exploratory clinical study, the main purpose is to evaluate the combination of envafolimab, lenvatinib VP-16 in the treatment of platinum-resistant recurrent epithelial ovarian cancer，primary fallopian tube cancer and primary peritoneal carcinoma.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer, Epithelial
• Intervention / Treatment: Drug: Envafolimab; Drug: Lenvatinib; Drug: VP-16

Detailed Description

Platinum-resistant patients who have received at least 1 line chemotherapy in the past and the recurrence time is less than 6 months will receive envafolimab combined with lenvatinib and VP-16 for 6 cycles, followed by single-agent envafolimab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang Shen, MD; Phone Number: 025-83262742; Email: shenyang0924@sina.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Zhongda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ≥18 years；
• ECOG 0-1
• Life expectancy of at least 3 months；
• Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer； Ovarian cancer patients with drug-resistant recurrence after platinum-based chemotherapy；
• At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
• Satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
• Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects；

Exclusion Criteria:

• Suffered from other malignant tumors within 5 years before the start of treatment in this study;
• Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
• Subjects with any severe and/or uncontrolled disease ；
• Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ；
• Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture；
• Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ；
• Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ；
• Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ；
• Allergic to the active ingredients or excipients of the study drug ；
• Unsuitable for the study or other chemotherapy determined by investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: envafolimab，lenvatinib，VP-16; envafolimab：400mg，sc，d1，Q3W； lenvatinib：8 mg(BW<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W； VP-16：50 mg/d, po,d1-14，Q3W	Drug: Envafolimab; 400mg，sc，d1，Q3W; Other Names: Immunotherapy; Drug: Lenvatinib; 8 mg(BW<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W; Other Names: Tyrosine kinase inhibitors; Drug: VP-16; 50 mg/d, po,d1-14，Q3W; Other Names: Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	objective response rate	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	12 months
PFS	progression free survival	12 months
DCR	disease control rate	9 months
AEs AEs	ａ advers adverse events	12 months

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Study Director: Yang Shen, MD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: ENLEN-OC-001

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