New cocktail of chemo, immunotherapy, and bladder drug takes on recurrent ovarian cancer
NCT ID NCT07261683
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether a combination of two chemotherapy drugs (paclitaxel or nab-paclitaxel), an immunotherapy (pembrolizumab), and a bladder drug (mirabegron) can shrink tumors in people with ovarian cancer that has come back after initial treatment. About 20 adults will receive the drugs and be monitored for tumor response and side effects. The goal is to see if this new mix is both effective and safe enough to pursue in larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel (or nab-paclitaxel), pembrolizumab, and mirabegron
- What this could lead to
- If this works, it could offer a new treatment option for people with ovarian cancer that has come back after initial therapy.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The drug combination may cause side effects or not shrink tumors as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment). * 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. Exclusion Criteria: * 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 \[CTLA-4\], tumor necrosis factor receptors OX-40 or CD137). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Obstetrics and Gynecology Hospital of Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200090, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer