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

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: Ovarian Cancer; Immunotherapy; Pembrolizumab
• Intervention / Treatment: Drug: Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cao, Doctor; Phone Number: 86 13301971027; Email: caokankan@126.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200090
      • Recruiting
      • Obstetrics and Gynecology Hospital of Fudan University
      • Contact: Wu, Doctor; Phone Number: 86 13764046908; Email: wuxin_fc@fudan.edu.cn

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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)	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	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	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	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	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	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	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	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	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	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	Biomarker testing for genome in exploratory analysis.	Baseline and 6 months from the the date of first study treatment

Collaborators and Investigators

• Sponsor: Obstetrics & Gynecology Hospital of Fudan University

Study record dates

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: immunotherapy; ovarian cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; pembrolizumab; mirabegron
• 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