Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| 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:
Drug: Lenvatinib
8 mg(BW<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W
Other Names:
Drug: VP-16
50 mg/d, po,d1-14，Q3W
Other Names:
|
Outcome Measures
Primary Outcome Measures
- ORR [6 months]
objective response rate
Secondary Outcome Measures
- OS [12 months]
overall survival
- PFS [12 months]
progression free survival
- DCR [9 months]
disease control rate
- AEs AEs [12 months]
ａ advers adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥18 years；
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ECOG 0-1
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Life expectancy of at least 3 months；
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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；
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At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
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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;
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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:
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Suffered from other malignant tumors within 5 years before the start of treatment in this study;
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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;
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Subjects with any severe and/or uncontrolled disease ；
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Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ；
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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；
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Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ；
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Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ；
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Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ；
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Allergic to the active ingredients or excipients of the study drug ；
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Unsuitable for the study or other chemotherapy determined by investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongda Hospital | Nanjing | Jiangsu | China | 210000 |
Sponsors and Collaborators
- Zhongda Hospital
Investigators
- Study Director: Yang Shen, MD, Zhongda Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ENLEN-OC-001