RecruitingPhase 2NCT07261683

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


Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

20 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining weekly paclitaxel or nab-paclitaxel (chemotherapy), pembrolizumab (an immunotherapy drug), and mirabegron (a drug used for overactive bladder, which also activates immune-boosting fat cells) can treat recurrent ovarian, fallopian tube, or peritoneal cancer. **You may be eligible if...** - You have confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back after prior treatment - You previously received at least one platinum-based chemotherapy regimen - You are in good overall physical condition (ECOG 0–1) **You may NOT be eligible if...** - You have autoimmune disease that requires systemic treatment - You have received prior pembrolizumab or similar checkpoint inhibitor drugs and experienced severe side effects - You have significant heart problems or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWeekly 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.


Locations(1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT07261683


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