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New treatment option for Ovarian Cancer
Official title Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT07261683
What this study is testing
What is Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron?
Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Has provided documented informed consent for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or...
- Has a platinum-free interval (PFI) of \< 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of \< 12...
You likely can't join if
- Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated...
- Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory...
- Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before enrollment.
- Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to paclitaxel/nab-paclitaxel, pembrolizumab, mirabegron and any of their...
- Has undergone major surgery within 3 weeks before enrollment or has complications/sequelae that have not yet recovered.
- Has a known additional malignancy that progressed or required active treatment within the last 5 years.
See the full eligibility criteria
- Has provided documented informed consent for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with...
- Has a platinum-free interval (PFI) of \< 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of \< 12 months if the last regimen received is a non-platinum-based.
- Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Has a life expectancy of ≥12 weeks.
- Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening.
- Has adequate organ function.
- Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent.
- Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
- Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4...
- Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before enrollment.
- Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to paclitaxel/nab-paclitaxel, pembrolizumab, mirabegron and any of their excipients.
- Has undergone major surgery within 3 weeks before enrollment or has complications/sequelae that have not yet recovered.
- Has a known additional malignancy that progressed or required active treatment within the last 5 years.
- Is pregnant or breastfeeding.
- Has a history of allogenic tissue/solid organ transplant.
- Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before enrollment.
- Has a history of active autoimmune disease.
- Has an active infection requiring systemic therapy.
- Has a history of human immunodeficiency virus (HIV) infection.
- Has a history of Hepatitis B or C virus infection.
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.