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This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zimberelimab plus metformin | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimberelimab | Drug | Zimberelimab 240mg IV every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first | Up to 2 years |
| Overall survival | The time from date of randomization until the date of death from any cause or last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Libing Xiang | Contact | 862164041990 | 2801 | xiang.libing@zs-hospital.sh.cn |
| Yulian Chen | Contact | 862164041990 | 2801 | emma_serendipity@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Libing Xiang | Department of Gynecologic Oncology, Zhongshan Hospital, Fudan University | Principal Investigator |
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| ID | Term |
|---|---|
| C000719848 | zimberelimab |
| C000711728 | spartalizumab |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin Hydrochloride | Drug | Metformin 2000mg PO QD |
|
|
| Up to 2 years |
| Disease control rate | The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD) assessed by the investigator in accordance with the RECIST 1.1 criteria | Up to 2 years |
| Duration of response | The time interval from the first record of disease response to disease progression or death (whichever occurs first) | Up to 2 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | The adverse event assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Up to 2 years |
| Patterns of subsequent recurrence | The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc.) | Up to 2 years |