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

NCT07261683 | Recruiting Phase 2

• 1 other identifier: FUOBGY-2025-202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Ovarian Cancer; Immunotherapy; Pembrolizumab

Keywords

ovarian cancer; immunotherapy

Outcome Measures

Primary Outcomes (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.

  Month 6

Secondary Outcomes (5)

• Progression Free Survival (PFS) at 6 Months

  Month 6

• Overall Survival (OS) at 6 Months

  Month 6

• Progression Free Survival (PFS) at 12 Months

  Month 12

• Overall Survival (OS) at 12 Months

  Month 12

• Incidence of grade 3-4 Adverse Events (AEs)

  up to 1 month after the end of treatment

Other Outcomes (6)

• Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity

  Baseline and 6 months from the the date of first study treatment

• Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity

  Baseline and 6 months from the the date of first study treatment

• Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity

  Baseline and 6 months from the the date of first study treatment

Study Arms (1)

Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron

EXPERIMENTAL

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

Interventions

Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron DRUG

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.

Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Eligible participants must self-identify as female and have a diagnosis of ovarian cancer with current or historical ovarian tissue.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

pembrolizumab; mirabegron

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Cao, Doctor

CONTACT

86 13301971027; caokankan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single-arm, open-label, Phase II interventional study designed to evaluate the efficacy and safety of weekly paclitaxel or nab-paclitaxel in combination with pembrolizumab and mirabegron in patients with recurrent ovarian cancer. All eligible participants will receive the same treatment regimen without randomization or masking. The study aims to assess treatment response, safety profile, and preliminary clinical benefit in this target population.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)