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Ovarian Cancer, EpithelialPhase 2NCT05422183

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

A Phase 2 study testing Envafolimab, Lenvatinib and VP-16 in people with Ovarian Cancer, Epithelial, run by Zhongda Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Cancer, Epithelial
What is being tested?
Envafolimab, Lenvatinib and VP-16
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
30 Jun 2022to 30 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥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；

Who cannot join

  • 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 ；
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Yang Shen, MD contact

025-83262742

shenyang0924@sina.cn

China1 site

  • Zhongda Hospital

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

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

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.

Read the 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

Being tested
Envafolimab, Lenvatinib, VP-16
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnvafolimabDrug

    Also called Immunotherapy

    400mg，sc，d1，Q3W

  • LenvatinibDrug

    Also called Tyrosine kinase inhibitors

    8 mg(BW<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W

  • VP-16Drug

    Also called Chemotherapy

    50 mg/d, po,d1-14，Q3W

Study groups in NCT05422183
Study groupRoleWhat they receive
envafolimab，lenvatinib，VP-16Experimentalenvafolimab：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
Receives: Drug: Envafolimab; Drug: Lenvatinib; Drug: VP-16

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    objective response rate

    Measured: 6 months

Secondary outcomes (4)

  1. OS

    overall survival

    Measured: 12 months

  2. PFS

    progression free survival

    Measured: 12 months

  3. DCR

    disease control rate

    Measured: 9 months

  4. AEs AEs

    ａ advers adverse events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start30 Jun 2022 (estimated)
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05422183
Sponsor's protocol ID
ENLEN-OC-001
Status last verified
Jun 2022
First submitted
13 Jun 2022
Last updated
16 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ding B, Yu T, Zheng S, Xu J, Ji F, Lin H, Zhao X, Qiu S, Shen Y. Combination therapy for platinum-resistant ovarian cancer: a novel at-home regimen with envafolimab, lenvatinib, and etoposide. Oncologist. 2025 Sep 1;30(9):oyaf210. doi: 10.1093/oncolo/oyaf210.

    PubMed 40658469

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab, Lenvatinib and VP-16 in people with Ovarian Cancer, Epithelial, run by Zhongda Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yang Shen, MD (025-83262742, shenyang0924@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05422183, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.

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