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

December 14, 2025 updated by: Xin Wu, Obstetrics & Gynecology Hospital of Fudan University

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:

i) 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?

Participants will:

i) 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200090
        • Recruiting
        • Obstetrics and Gynecology Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron
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.
Drug: Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Month 6
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.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3-4 Adverse Events (AEs)
Time Frame: up to 1 month after the end of treatment
Incidence of grade 3-4 AEs, according to CTCAE, version 5.0
up to 1 month after the end of treatment
Progression Free Survival (PFS) at 6 Months
Time Frame: Month 6

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.
Month 6
Overall Survival (OS) at 6 Months
Time Frame: Month 6
OS at 6 months is defined as the percentage of patients who are alive at 6 months from the date of first study treatment.
Month 6
Progression Free Survival (PFS) at 12 Months
Time Frame: Month 12

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.
Month 12
Overall Survival (OS) at 12 Months
Time Frame: Month 12
OS at 12 months is defined as the percentage of patients who are alive at 12 months from the date of first study treatment.
Month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity
Time Frame: Baseline and 6 months from the the date of first study treatment
Biomarker testing for PD-L1 expression in exploratory analysis.
Baseline and 6 months from the the date of first study treatment
Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity
Time Frame: Baseline and 6 months from the the date of first study treatment
Biomarker testing for BMI (weight and height will be combined to report BMI in kg/m^2) in exploratory analysis.
Baseline and 6 months from the the date of first study treatment
Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity
Time Frame: Baseline and 6 months from the the date of first study treatment
Biomarker testing for tumor microenvironment (including density and state of CD8+ T cells density and other immune cells) in exploratory analysis.
Baseline and 6 months from the the date of first study treatment
Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity
Time Frame: Baseline and 6 months from the the date of first study treatment
Biomarker testing for circulating anti-tumor immunity (including density and state of CD8+ T cells density and other immune cells) in exploratory analysis.
Baseline and 6 months from the the date of first study treatment
Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity
Time Frame: Baseline and 6 months from the the date of first study treatment
Biomarker testing for transcriptome in exploratory analysis.
Baseline and 6 months from the the date of first study treatment
Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity
Time Frame: Baseline and 6 months from the the date of first study treatment
Biomarker testing for genome in exploratory analysis.
Baseline and 6 months from the the date of first study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUOBGY-2025-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe