Weekly paclitaxel or nab-paclitaxel with pembrolizumab and mirabegron for recurrent ovarian cancer

A Phase II Study Evaluating the Efficacy and Safety of Weekly Paclitaxel or Nab-Paclitaxel Combined With Pembrolizumab and Mirabegron in Patients With Recurrent Ovarian Cancer

This study tests whether weekly paclitaxel or nab-paclitaxel combined with pembrolizumab and daily mirabegron can shrink tumors and be safe for adults with relapsed ovarian cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (Academic / other)
• Drugs / interventions: pembrolizumab, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07261683 on ClinicalTrials.gov

What this trial studies

This is a Phase II trial giving participants weekly paclitaxel or nab-paclitaxel together with pembrolizumab every 21 days and daily mirabegron to see if the combination reduces tumor size and is tolerable. Eligible adults have relapsed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with measurable disease and generally good performance status. Participants will attend clinic visits about every two months for imaging, safety monitoring, and will keep a symptom diary. The main outcomes are change in tumor burden by RECIST 1.1 and the types and frequency of treatment-related adverse events.

Who should consider this trial

Good fit: Adults with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who relapsed after frontline platinum-based therapy (PFI/TFI < 12 months), have measurable disease, ECOG 0–1, and a life expectancy of at least 12 weeks are the intended participants.

Not a fit: Patients without measurable disease, with ECOG performance status ≥2, significant uncontrolled comorbidities, or a longer platinum-free interval (≥12 months) may not be eligible and are less likely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the regimen could shrink tumors and delay disease progression, offering a new treatment option for patients with relapsed ovarian cancer.

How similar studies have performed: Combining chemotherapy with PD-1 inhibitors has produced mixed but sometimes promising results in ovarian cancer, while adding mirabegron is a novel element that has not been well studied in this disease.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Cao, Doctor

Conditions Ovarian Cancer; Immunotherapy; Pembrolizumab; ovarian cancer; immunotherapy