Actively Recruiting
Phase II Study of Weekly Paclitaxel or Nab-Paclitaxel Combined With 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a drug regimen combining weekly paclitaxel or nab-paclitaxel, pembrolizumab, and mirabegron to treat adults with relapsed ovarian cancer. This Phase II study aims to determine if this combination reduces tumor size and to understand what medical issues participants might experience while taking these drugs. Participants will receive weekly doses of paclitaxel or nab-paclitaxel and pembrolizumab every 21 days through intravenous infusion. They will also take mirabegron orally every day starting on Day 1 of each 21-day cycle. Treatment continues until participants cannot tolerate it or their disease progresses. During the study, participants will visit the clinic every two months for checkups and tests. They will keep a diary to record symptoms. Researchers will measure tumor response at 6 months and monitor survival and progression at 6 and 12 months. Safety is assessed by tracking severe side effects up to one month after treatment ends. The study runs from December 2025 to November 2028.
CONDITIONS
Brief 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 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 frontline platinum-based chemotherapy after surgery with documented disease recurrence
- Platinum-free interval or treatment-free interval less than 12 months
- Measurable disease at baseline by 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 therapy
You will not qualify if you...
- Nonepithelial cancers, borderline tumors, mucinous or seromucinous tumors, malignant Brenner's tumor, or undifferentiated carcinoma
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other co-inhibitory T-cell receptor agents
- Received systemic anticancer therapy 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 complications
- Additional malignancy requiring treatment within last 5 years
- Pregnant or breastfeeding
- History of allogenic tissue or organ transplant
- History of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months
- History of active autoimmune disease
- Active infection requiring systemic therapy
- History of HIV infection
- History of Hepatitis B or C infection
- Conditions or therapies that might confound study results
- Known psychiatric or substance abuse disorder interfering with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until intolerance or disease progression
Participants receive weekly paclitaxel or nab-paclitaxel plus pembrolizumab via intravenous infusion, along with daily oral mirabegron starting on Day 1 of each 21-day cycle until intolerance or disease progression.
Weekly visits for treatment and assessments
Duration - Up to 1 month after the end of treatment
Participants are monitored for safety and survival outcomes after the end of treatment.
Approximately 1 follow-up visit
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
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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