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The goal of this clinical trial is to learn if drug regimen pegylated liposomal doxorubicin and adebrelimab with or without mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of drug regimen pegylated liposomal doxorubicin and adebrelimab with or without mirabegron. The main questions it aims to answer are:
Does drug pegylated liposomal doxorubicin and adebrelimab with or without mirabegron reduce tumor volume? What medical problems do participants have when taking drug pegylated liposomal doxorubicin and adebrelimab with or without mirabegron?
Researchers will compare drug regimen pegylated liposomal doxorubicin and adebrelimab with mirabegron to a drug regimen pegylated liposomal doxorubicin and adebrelimab without mirabegron to see which drug regimen works better to treat relapsed ovarian cancer.
Participants will:
Take drug pegylated liposomal doxorubicin and adebrelimab every 21 days with or without everyday mirabegron Visit the clinic once every 2 months for checkups and tests Keep a diary of their symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated liposomal doxorubicin plus adebrelimab with mirabegron | Experimental |
| |
| Pegylated liposomal doxorubicin plus adebrelimab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated liposomal doxorubicin plus adebrelimab with mirabegron | Drug | Participants receive pegylated liposomal doxorubicin at a dose of 20mg/m2 plus adebrelimab at a dose of 20 mg/kg 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 randomization. |
| 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 randomization |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity |
Inclusion Criteria:
Exclusion Criteria:
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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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|
| Pegylated liposomal doxorubicin plus adebrelimab | Drug | Participants receive pegylated liposomal doxorubicin at a dose of 20mg/m2 plus adebrelimab at a dose of 20 mg/kg via intravenous (IV) infusion plus on Day 1 of each 21-day cycle until intolerance or disease progression. |
|
| 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 randomization. | 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 randomization. | 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 randomization. | 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 randomization |
| 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 randomization |
| 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 randomization |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Biomarker testing for transcriptome in exploratory analysis. | Baseline and 6 months from the randomization |
| Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Biomarker testing for genome in exploratory analysis. | Baseline and 6 months from the randomization |
| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| C520025 | mirabegron |
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