Clinical trial · Interventional
Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma
Zimberelimab Combined With Metformin in the Treatment of Recurrent Ovarian Clear Cell Carcinoma: A Pilot Study
NCT05759312CI-TRIAL-00064529unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Clear Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hydrochloride | Drug | Metformin | ALIAS |
| Zimberelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- zimberelimab plus metformin
- description
- 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.
- interventionNames
- Drug: Zimberelimab
- Drug: Metformin Hydrochloride
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Up to 2 years
- description
- 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 outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.