Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma

Ovarian Clear Cell Carcinoma Clinical Trial

Official title:

Zimberelimab Combined With Metformin in the Treatment of Recurrent Ovarian Clear Cell Carcinoma: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05759312
• Other study ID #: zsfud-OC-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2023
• Est. completion date: February 2025

Study information

• Verified date: February 2023
• Source: Fudan University
• Contact: Libing Xiang
• Phone: 862164041990
• Email: xiang.libing[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Clear Cell Carcinoma

Intervention

Drug:
• Zimberelimab
Zimberelimab 240mg IV every 2 weeks
• Metformin Hydrochloride
Metformin 2000mg PO QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Overall survival	The time from date of randomization until the date of death from any cause or last follow-up	Up to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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