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Trial Title:
Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma
NCT ID:
NCT05759312
Condition:
Ovarian Clear Cell Carcinoma
Conditions: Official terms:
Carcinoma
Adenomyoepithelioma
Adenocarcinoma, Clear Cell
Metformin
Conditions: Keywords:
Ovarian Clear Cell Carcinoma
Immune Checkpoint Inhibitor
Metformin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zimberelimab
Description:
Zimberelimab 240mg IV every 2 weeks
Arm group label:
zimberelimab plus metformin
Other name:
Anti PD-1
Intervention type:
Drug
Intervention name:
Metformin Hydrochloride
Description:
Metformin 2000mg PO QD
Arm group label:
zimberelimab plus metformin
Other name:
Metformin
Summary:
This study aims to evaluate the safety and effectiveness of zimberelimab combined with
metformin in treating relapsed/persistent ovarian clear cell carcinoma.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
March 2023
Completion date:
February 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759312
