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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Biomarker testing for PD-L1 expression in exploratory analysis. | Baseline and 6 months from the the date of first study treatment |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity |
Inclusion Criteria:
Exclusion Criteria:
Eligible participants must self-identify as female and have a diagnosis of ovarian cancer with current or historical ovarian tissue.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cao, Doctor | Contact | 86 13301971027 | caokankan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200090 | China |
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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.
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|
| 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. | 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. | 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. | Month 12 |
| Incidence of grade 3-4 Adverse Events (AEs) | Incidence of grade 3-4 AEs, according to CTCAE, version 5.0 | up to 1 month after the end of treatment |
Biomarker testing for BMI (weight and height will be combined to report BMI in kg/m^2) in exploratory analysis. |
| Baseline and 6 months from the the date of first study treatment |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Biomarker testing for tumor microenvironment (including density and state of CD8+ T cells density and other immune cells) in exploratory analysis. | Baseline and 6 months from the the date of first study treatment |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Biomarker testing for circulating anti-tumor immunity (including density and state of CD8+ T cells density and other immune cells) in exploratory analysis. | Baseline and 6 months from the the date of first study treatment |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Biomarker testing for transcriptome in exploratory analysis. | Baseline and 6 months from the the date of first study treatment |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Biomarker testing for genome in exploratory analysis. | Baseline and 6 months from the the date of first study treatment |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C520025 | mirabegron |
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