NCT05422183

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Ovarian Cancer, Epithelial

Interventions

Type	Name	Description
DRUG	Envafolimab	400mg，sc，d1，Q3W
DRUG	Lenvatinib	8 mg(BW\<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W
DRUG	VP-16	50 mg/d, po,d1-14，Q3W

Timeline

• Start date: 2022-06-30
• Primary completion: 2022-12-30
• Completion: 2023-12-30
• First posted: 2022-06-16
• Last updated: 2022-06-16

Locations

1 site across 1 country: China