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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGObjective 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.
Time frame: Month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
Incidence of grade 3-4 Adverse Events (AEs)
Incidence of grade 3-4 AEs, according to CTCAE, version 5.0
Time frame: up to 1 month after the end of treatment
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