Clinical trial NCT05422183: Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer, Epithelial
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: ORR
timeFrame: 6 months
Secondary outcomes:
measure: OS
timeFrame: 12 months
measure: PFS
timeFrame: 12 months
measure: DCR
timeFrame: 9 months
measure: AEs AEs
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Yang Shen, MD
role: STUDY_DIRECTOR
References: