Combining pegylated liposomal doxorubicin and adebrelimab with or without mirabegron for relapsed ovarian cancer

Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in Relapsed Ovarian Cancer: a Randomized, Controlled, Open-label Trial

This study is testing a new treatment combination for adults with relapsed ovarian cancer to see if adding mirabegron to pegylated liposomal doxorubicin and adebrelimab makes it work better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 296 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (Academic / other)
• Drugs / interventions: adebrelimab, radiation, doxorubicin
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06791460 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of a treatment regimen combining pegylated liposomal doxorubicin and adebrelimab, with or without the addition of mirabegron, in adults with relapsed ovarian cancer. Participants will receive the treatment every 21 days and will be monitored for tumor volume reduction and any associated medical problems. The study will compare the outcomes of the two treatment regimens to determine which is more effective in managing the disease.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically confirmed relapsed ovarian, fallopian tube, or primary peritoneal carcinoma who have received prior platinum-based chemotherapy.

Not a fit: Patients who have not had a documented disease recurrence after initial treatment or those with a platinum-free interval of 12 months or more may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed ovarian cancer.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using pegylated liposomal doxorubicin in ovarian cancer have shown promise in previous studies.

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) or has participated in prior adebrelimab studies.
* Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before randomization.
* Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to pegylated liposomal doxorubicin, adebrelimab, mirabegron and any of their excipients.
* Has undergone major surgery within 3 weeks before randomization 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 randomization.
* 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 Recurrent