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New cocktail of chemo, immunotherapy, and bladder drug takes on recurrent ovarian cancer

NCT ID NCT07261683

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Obstetrics and Gynecology Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200090, China

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