Ovarian Clear Cell Carcinoma
Conditions
Keywords
Ovarian Clear Cell Carcinoma, Immune Checkpoint Inhibitor, Metformin
Brief 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.
Interventions
DRUGZimberelimab
Zimberelimab 240mg IV every 2 weeks
DRUGMetformin Hydrochloride
Metformin 2000mg PO QD
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to 2 years | The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to 2 years | The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first |
| Overall survival | Up to 2 years | The time from date of randomization until the date of death from any cause or last follow-up |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to 2 years | The adverse event assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Duration of response | Up to 2 years | The time interval from the first record of disease response to disease progression or death (whichever occurs first) |
| Patterns of subsequent recurrence | Up to 2 years | The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc.) |
| Disease control rate | Up to 2 years | 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 |
Contacts
Primary ContactLibing Xiang
Backup ContactYulian Chen
Outcome results
None listed