Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer

Adebrelimab Plus Chemotherapy and Bevacizumab Induction Therapy Followed by Maintenance Therapy With Adebrelimab Plus Fluzoparib and Bevacizumab in Platinum-Sensitive Relapsed Ovarian Cancer (CHANGCHUN): A Single-Arm, Exploratory Study

NCT06446206•The First Hospital of Jilin University

View on ClinicalTrials.gov

Summary

The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus chemotherapy and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib (PARP inhibitor)and bevacizumab in platinum-sensitive relapsed ovarian cancer.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients volunteered to participate in this study after full informed consent and signed a written informed consent form;
•2. Aged 18-75 years old;
•3. Pathologically confirmed ovarian epithelial cancer, epithelial fallopian tube cancer, or primary peritoneal cancer;
•4. International Federation of Gynecology and Obstetrics (FIGO) 2018 edition staging III-IV;
•5. Having received no more than 2 prior lines of platinum-containing chemotherapy and ≥ 6 months between the time of last chemotherapy and tumor recurrence;
•6. No more than 1 prior PARP inhibitor;
•7. Negative for germline breast cancer susceptibility gene(BRCA) mutations;
•8. At least 1 measurable lesion according to RECIST 1.1 evaluation criteria;
•9. Patients with expected survival of ≥12 weeks;
•10. Have an Eastern Cooperative Oncology Group(ECOG) Performance Status(PS) score of 0-1;
+12 more criteria

Exclusion Criteria

•1. Known hypersensitivity or severe allergic reactions to the study drug or any of its excipients;
•2. Concurrent other incurable malignancies;
•3. The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases;
•4. Pregnancy or confirmed by blood or urine Human Chorionic Gonadotropin(HCG) test or lactation, or subjects of childbearing potential who are unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
•5. Difficult-to-control diabetes mellitus (defined as high fluctuations in blood glucose that interfere with the patient's life as well as frequent hypotension despite standard insulin therapy and frequent blood glucose monitoring);
•6. Myocardial infarction, severe/unstable angina pectoris, New York Heart Association(NYHA) class 2 or greater cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure, uncontrolled hypertension of moderate or greater severity (Systolic Blood Pressure \>160 mm Hg or Diastolic Blood Pressure \>100 mm Hg) within 4 weeks prior to the first study dose, known coronary artery disease, congestive heart failure that does not meet the above criteria congestive heart failure or left ventricular ejection fraction \<50% that meets the above criteria must be treated with an optimally stabilized medical regimen as determined by the treating physician and, if appropriate, in consultation with a cardiologist;
•7. Patients with a history of neurologic autoimmune disease, or moderate to severe autoimmune disease, or high doses of immunosuppressive agents for symptom control
•8. History of known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
•9. Receipt of any of the following medications or treatments prior to the first study drug treatment
•1. major surgery within 6 weeks (tissue biopsies and Peripherally Inserted Central Catheter or infusion port implantation via peripheral venous puncture for diagnostic purposes are permitted)
+4 more criteria

Key Dates

Start Date

June 1, 2024

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2028

Last Updated

June 6, 2024

Enrollment

ESTIMATED participants

Conditions

Platinum-sensitive Relapsed Ovarian Cancer

Interventions

Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib

DRUG