Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age ≥ 18 years to ≤ 75 years

• Pathologic confirmed ovarian clear cell carcinoma

• Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy

• According to the definition of RECIST1.1, the patient must have measurable lesions

• PD-L1 Combined Positive Score ≥ 1

• ECOG performance status of 0 to 2

• Adequate bone marrow, liver, and renal function to receive combined immunotherapy

• Written informed consent

Exclusion Criteria:

• Histological evidence of non-ovarian clear cell carcinoma

• Lack of tumor samples (archived and/or recently obtained)

• Previous administration of immunotherapy

• Patients have been vaccinated with the live vaccine or received anti-tumor treatment within 4 weeks before the first administration

• An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) within 2 years before the first administration

• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity) Symptomatic or uncontrolled visceral metastases that require simultaneous treatment

• Patients are known to be allergic to the active ingredients or excipients of zimberelimab or metformin

• Known human immunodeficiency virus (HIV) infection history (HIV 1/2 antibody positive).

• Untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center)

• Contraindications to metformin: kidney dysfunction or abnormal creatinine from any cause; acute or metabolic acidosis