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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Zimberelimab 240mg IV every 2 weeks
Metformin 2000mg PO QD
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
Time frame: Up to 2 years
Progression-free survival
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Time frame: Up to 2 years
Overall survival
The time from date of randomization until the date of death from any cause or last follow-up
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.)
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Time frame: Up to 2 years