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Ovarian CancerPhase 2NCT07261683

Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer

A Phase 2 study testing Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron in people with Ovarian Cancer and Immunotherapy, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if drug regimen weekly paclitaxel/nab-paclitaxel, pembrolizumab, and mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of the drug regimen. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer, Immunotherapy, Pembrolizumab
What is being tested?
Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Dec 2025to 30 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has provided documented informed consent for the study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment).
  • Has a platinum-free interval (PFI) of < 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of < 12 months if the last regimen received is a non-platinum-based.
  • Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
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  • Has a life expectancy of ≥12 weeks.
  • Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening.
  • Has adequate organ function.
  • Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent.

Who cannot join

  • Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
  • Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], tumor necrosis factor receptors OX-40 or CD137).
  • Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before enrollment.
  • Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to paclitaxel/nab-paclitaxel, pembrolizumab, mirabegron and any of their excipients.
  • Has undergone major surgery within 3 weeks before enrollment or has complications/sequelae that have not yet recovered.
  • Has a known additional malignancy that progressed or required active treatment within the last 5 years.
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  • Is pregnant or breastfeeding.
  • Has a history of allogenic tissue/solid organ transplant.
  • Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before enrollment.
  • Has a history of active autoimmune disease.
  • Has an active infection requiring systemic therapy.
  • Has a history of human immunodeficiency virus (HIV) infection.
  • Has a history of Hepatitis B or C virus infection.
  • Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cao, Doctor contact

86 13301971027

caokankan@126.com

China1 site, 1 recruiting

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200090

    Wu, Doctor, 86 13764046908, wuxin_fc@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study Evaluating the Efficacy and Safety of Weekly Paclitaxel or Nab-Paclitaxel Combined With Pembrolizumab and Mirabegron in Patients With Recurrent Ovarian Cancer

The goal of this clinical trial is to learn if drug regimen weekly paclitaxel/nab-paclitaxel, pembrolizumab, and mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of the drug regimen. The main questions it aims to answer are:

  1. Does drug weekly paclitaxel/nab-paclitaxel, pembrolizumab, and mirabegron reduce tumor volume? ii) What medical problems do participants have when taking drug weekly paclitaxel/nab-paclitaxel, pembrolizumab, and mirabegron?
Read more

Participants will:

  1. Take drug paclitaxel/nab-paclitaxel every week and pembrolizumab every 21 days with everyday mirabegron ii) Visit the clinic once every 2 months for checkups and tests iii) Keep a diary of their symptoms
Being tested
Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron
Keywords
ovarian cancer, immunotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and MirabegronDrug

    Participants receive weekly paclitaxel/nab-paclitaxel plus pembrolizumab via intravenous (IV) infusion plus on Day 1 of each 21-day cycle orally with daily mirabegron until intolerance or disease progression.

Study groups in NCT07261683
Study groupRoleWhat they receive
Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and MirabegronExperimentalParticipants receive weekly paclitaxel/nab-paclitaxel plus pembrolizumab via intravenous (IV) infusion plus on Day 1 of each 21-day cycle orally with daily mirabegron until intolerance or disease progression.
Receives: Drug: Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron

What is being measured

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

  1. Objective response rate (ORR)

    Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). ORR was defined as the percentage of participants who had a Complete Response (Disappearance of all target lesions) or a Partial Response (≥30% decrease in the sum of the longest diameter of target lesions) using RECIST 1.1 based on BICR.

    Measured: Month 6

Secondary outcomes (5)

  1. Progression Free Survival (PFS) at 6 Months

    PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm.

    The appearance of ≥1 new lesion is also PD. PFS at 6 months is defined as the percentage of patient who was progression free at 6 months from the date of first study treatment.

    Measured: Month 6

  2. Overall Survival (OS) at 6 Months

    OS at 6 months is defined as the percentage of patients who are alive at 6 months from the date of first study treatment.

    Measured: Month 6

  3. Progression Free Survival (PFS) at 12 Months

    PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm.

    The appearance of ≥1 new lesion is also PD. PFS at 12 months is defined as the percentage of patient who was progression free at 12 months from the date of first study treatment.

    Measured: Month 12

  4. Overall Survival (OS) at 12 Months

    OS at 12 months is defined as the percentage of patients who are alive at 12 months from the date of first study treatment.

    Measured: Month 12

  5. Incidence of grade 3-4 Adverse Events (AEs)

    Incidence of grade 3-4 AEs, according to CTCAE, version 5.0

    Measured: up to 1 month after the end of treatment

Timeline

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

  1. First posted3 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2028 (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
NCT07261683
Sponsor's protocol ID
FUOBGY-2025-202
Status last verified
Dec 2025
First submitted
21 Nov 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron in people with Ovarian Cancer and Immunotherapy, run by Obstetrics & Gynecology Hospital of Fudan University 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Cao, Doctor (86 13301971027, caokankan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Month 6). 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 NCT07261683.

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 19 Dec 2025.

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