Recurrent Ovarian Cancer
Conditions
Interventions
Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron :Participants receive weekly paclitaxel/nab-paclitaxel plus pembrolizumab via intravenous (IV) infusion plus on Day 1 of each 21-day cyc
Sponsors
Obstetrics and Gynecology Hospital, Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject understands the study procedures, has signed the informed consent form, and agrees to participate in the study; 2. Female subjects aged >=18 and =10 mm; for lesions measured by chest X-ray, the longest diameter must be >=20 mm. Lymph nodes must be >=15 mm in short axis when assessed by CT or MRI; 6. Subjects must have received one prior platinum-based chemotherapy regimen and subsequently experienced disease progression. The platinum-free interval (PFI), defined as the time from the last dose of platinum-based therapy to documented progression, must be 12 weeks; 8. Adequate organ and bone marrow function within 14 days prior to enrollment, including: (1). Absolute neutrophil count (ANC) >=1500/µL; (2). Platelet count >=100,000/µL; (3) Hemoglobin >=10 g/dL; (4) Serum albumin >=2.8 g/dL; (5) Serum creatinine =60 mL/min (calculated by Cockcroft–Gault formula); (6) Total bilirubin <=1.5 × ULN or direct bilirubin <=1.0 × ULN; (7) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 × ULN, or <=5 × ULN in the presence of liver metastases; 9. Ability to comply with study procedures; 10. Toxicities from any prior chemotherapy must have resolved to <= CTCAE Grade 1 or to baseline levels, except for <= CTCAE Grade 2 stable sensory neuropathy or alopecia; 11. Availability of tumor tissue collected from a prior cytoreductive surgery or provision of a newly obtained tumor biopsy at screening.
Exclusion criteria
Exclusion criteria: 1. Histological types including non-epithelial cancers, borderline tumors, mucinous tumors, seromucinous tumors with predominant mucinous components, malignant Brenner tumors, and undifferentiated carcinomas; 2. Prior treatment with anti–PD-1, anti–PD-L1/2, anti–CTLA-4, or any agents targeting T-cell co-stimulatory or co-inhibitory molecules; 3. Receipt of systemic antitumor therapy, including radiotherapy or maintenance therapy, within 4 weeks prior to enrollment; 4. Known hypersensitivity to the investigational product or to any active or inactive components with similar chemical structures, or a history of severe hypertension; 5. Major surgery within 3 weeks prior to study initiation, or unresolved complications/sequelae from such surgery; 6. History of any invasive malignancy other than ovarian cancer within 5 years prior to enrollment; 7. Prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 8. History of organ transplantation; 9. Pregnant or breastfeeding women; 10. Presence of severe or uncontrolled medical conditions, including but not limited to: (1). Uncontrolled nausea and vomiting, symptomatic or unrelieved bowel obstruction, inability to swallow study medication, or any gastrointestinal disorder that may interfere with drug absorption or metabolism; (2). Active viral infections such as HIV, hepatitis B, hepatitis C, or others; (3). Uncontrolled seizures, unstable spinal cord compression, superior vena cava syndrome, or psychiatric disorders that may impair the ability to provide informed consent. (4). Immunodeficiency (except splenectomy) or any condition that, in the investigator’s judgment, may expose the patient to excessive toxicity. 11. History of bleeding tendency or thrombosis: (1). Any CTCAE Grade 2 bleeding event within 3 months prior to screening, or CTCAE Grade =3 bleeding event within 6 months prior to screening. (2) History of gastrointestinal bleeding within 6 months prior to screening or clear risk factors for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active peptic ulcer lesions, or fecal occult blood test >=++ . (3) Active bleeding or coagulation disorders, bleeding diathesis, or current use of thrombolytic or anticoagulant therapy; (4) Patients requiring anticoagulation therapy with warfarin or heparin; (5) Patients requiring long-term antiplatelet therapy (e.g., aspirin, clopidogrel); (6) Thrombotic or embolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack) or pulmonary embolism; 12. Significant cardiovascular history: (1) New York Heart Association (NYHA) Class III or IV congestive heart failure; (2) Unstable angina, newly diagnosed angina, or myocardial infarction within 12 months prior to screening; (3) Clinically significant arrhythmias requiring therapeutic intervention (patients receiving ß-blockers or digoxin may be eligible); (4) CTCAE Grade >=2 valvular heart disease; (5) Poorly controlled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg); 13. Patients with active or recurrent autoimmune diseases, including but not limited to: (1) Neurologic autoimmune diseases such as multiple sclerosis, autoimmune (demyelinating) neuropathies, Guillain–Barré syndrome, or myasthenia gravis. (2) Systemic autoimmune diseases such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn’s disease,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month progression-free survival;12-month overall survival (OS) rate; | — |
Countries
China
Contacts
Public ContactWu Xin
Obstetrics and Gynecology Hospital of Fudan University
Outcome results
None listed