NCT05759312

Brief Summary

This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

February 25, 2023

Last Update Submit

February 25, 2023

Conditions

Ovarian Clear Cell Carcinoma

Keywords

Ovarian Clear Cell CarcinomaImmune Checkpoint InhibitorMetformin

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria

    Up to 2 years

Secondary Outcomes (6)

  • Progression-free survival

    Up to 2 years

  • Overall survival

    Up to 2 years

  • Disease control rate

    Up to 2 years

  • Duration of response

    Up to 2 years

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Up to 2 years

  • +1 more secondary outcomes

Study Arms (1)

zimberelimab plus metformin

EXPERIMENTAL

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.

Drug: ZimberelimabDrug: Metformin Hydrochloride

Interventions

ZimberelimabDRUG

Zimberelimab 240mg IV every 2 weeks

Also known as: Anti PD-1
zimberelimab plus metformin
Metformin HydrochlorideDRUG

Metformin 2000mg PO QD

Also known as: Metformin
zimberelimab plus metformin

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

zimberelimabspartalizumabMetformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Libing Xiang

    Department of Gynecologic Oncology, Zhongshan Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Libing Xiang

CONTACT

862164041990xiang.libing@zs-hospital.sh.cn

Yulian Chen

CONTACT

862164041990emma_serendipity@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 8, 2023

Study Start

March 1, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

March 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share