Zimberelimab Combined With Metformin in the Treatment of Recurrent Ovarian Clear Cell Carcinoma: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Objective response rate
研究概览
简要总结
This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
zimberelimab plus metformin
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.
干预措施: Zimberelimab (Drug)
zimberelimab plus metformin
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.
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Objective response rate
时间窗: Up to 2 years
The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria
次要结局
- Overall survival(Up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to 2 years)
- Patterns of subsequent recurrence(Up to 2 years)
- Disease control rate(Up to 2 years)
- Duration of response(Up to 2 years)
- Progression-free survival(Up to 2 years)
研究者
Libing Xiang
Associate chief physician
Fudan University