Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma
NCT ID: NCT05759312
Last Updated: 2023-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2023-03-31
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Zimberelimab
Zimberelimab 240mg IV every 2 weeks
Metformin Hydrochloride
Metformin 2000mg PO QD
Interventions
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Zimberelimab
Zimberelimab 240mg IV every 2 weeks
Metformin Hydrochloride
Metformin 2000mg PO QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Libing Xiang
Associate chief physician
Principal Investigators
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Libing Xiang
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecologic Oncology, Zhongshan Hospital, Fudan University
Central Contacts
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Other Identifiers
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zsfud-OC-001
Identifier Type: -
Identifier Source: org_study_id
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