Actively Recruiting
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent for the study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Received a front line platinum-based regimen after primary or interval debulking surgery with documented disease recurrence
- Platinum-free interval of less than 12 months if last regimen was platinum-based, or treatment-free interval of less than 12 months if last regimen was non-platinum-based
- Measurable disease at baseline based on RECIST 1.1
- Life expectancy of at least 12 weeks
- Provided tumor tissue sample from prior surgery or fresh biopsy at screening
- Adequate organ function
- Not recovered from adverse events to Grade 1 or prior treatment level from previous agents
You will not qualify if you...
- Nonepithelial cancers, borderline tumors, mucinous or seromucinous tumors predominantly mucinous, malignant Brenner's tumor, or undifferentiated carcinoma
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other co-inhibitory T-cell receptor agents
- Received systemic anticancer therapy including radiation or maintenance therapy within 4 weeks before enrollment
- Severe hypersensitivity (Grade 3 or higher) or uncontrolled hypertension to study drugs or excipients
- Major surgery within 3 weeks before enrollment or unresolved surgery complications
- Known additional malignancy requiring treatment or progression within last 5 years
- Pregnant or breastfeeding
- History of allogenic tissue or solid organ transplant
- History of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before enrollment
- History of active autoimmune disease
- Active infection requiring systemic therapy
- History of HIV infection
- History of Hepatitis B or C infection
- Any condition, therapy, laboratory abnormality, or circumstance that could confound study results
- Known psychiatric or substance abuse disorder interfering with study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200090
Actively Recruiting
Research Team
C
Cao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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