Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma

Fudan University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Ovarian Clear Cell Carcinoma

Treatments: Drug: Metformin Hydrochloride; Drug: Zimberelimab

Study type: Interventional

Funder types: Other

Identifiers

NCT05759312

zsfud-OC-001

Details and patient eligibility

About

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

Full description

Ovarian clear cell carcinoma (OCCC) is one of the rare subtypes of ovarian cancer, yet its prognosis is extremely poor. Previous studies indicate that PD-1 inhibitors may have clinical benefits for OCCC patients. This single-arm, single-center, pilot study evaluates the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

zimberelimab plus metformin

Experimental group

Description:

Patients will start metformin at 1,000mg by mouth once daily during a 7-day induction period prior to starting zimberelimab. The dose will be increased by 500mg every 7 days until reaching the target dose of 2000mg. Zimberelimab will be administered at a fixed dose of 240 mg IV every 14 days. Treatment will continue until disease progression confirmed by RECIST criteria v1.1, intolerable toxicity, or withdrawal of consent.

Treatment:

Drug: Zimberelimab

Drug: Metformin Hydrochloride