Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma

Sponsor
Fudan University
Study ID
NCT05759312
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Ovarian Clear Cell Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Zimberelimab — DRUG
    Zimberelimab 240mg IV every 2 weeks
  • Metformin Hydrochloride — DRUG
    Metformin 2000mg PO QD

Study Details

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

Key Dates

Start date
Mar 31, 2023
Status verified
Feb 2023
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: zimberelimab plus metformin
    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.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 2 years ]

Central Contacts

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