Clinical trial NCT05759312: Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma
Official title: Zimberelimab Combined With Metformin in the Treatment of Recurrent Ovarian Clear Cell Carcinoma: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ovarian Clear Cell Carcinoma
Keywords: Ovarian Clear Cell Carcinoma
Immune Checkpoint Inhibitor
Metformin
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Up to 2 years
measure: Disease control rate
timeFrame: Up to 2 years
measure: Duration of response
timeFrame: Up to 2 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to 2 years
measure: Patterns of subsequent recurrence
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gynecologic Oncology, Zhongshan Hospital, Fudan University
name: Libing Xiang
role: PRINCIPAL_INVESTIGATOR
References: