Ovarian Clear Cell CarcinomaPhase 1/2NCT05759312
Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma
A Phase 1/2 study testing Zimberelimab and Metformin Hydrochloride in people with Ovarian Clear Cell Carcinoma, run by Fudan University.
Trial summary
This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Clear Cell Carcinoma
- What is being tested?
- Zimberelimab and Metformin Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Zimberelimab Combined With Metformin in the Treatment of Recurrent Ovarian Clear Cell Carcinoma: A Pilot Study
This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.
Read the 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.
- Conditions
- Ovarian Clear Cell Carcinoma
- Being tested
- Zimberelimab, Metformin Hydrochloride
- Keywords
- Ovarian Clear Cell Carcinoma, Immune Checkpoint Inhibitor, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZimberelimabDrug
Also called Anti PD-1
Zimberelimab 240mg IV every 2 weeks
Metformin HydrochlorideDrug
Also called Metformin
Metformin 2000mg PO QD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zimberelimab; Drug: Metformin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
Secondary outcomes (6)
Progression-free survival
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Measured: Up to 2 years
Overall survival
The time from date of randomization until the date of death from any cause or last follow-up
Measured: Up to 2 years
Disease control rate
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
Measured: Up to 2 years
Duration of response
The time interval from the first record of disease response to disease progression or death (whichever occurs first)
Measured: Up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The adverse event assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 2 years
Patterns of subsequent recurrence
The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc.)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Clear Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Libing Xiang, Fudan University
- Investigators
- Libing Xiang, Principal investigator, Department of Gynecologic Oncology, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759312
- Sponsor's protocol ID
- zsfud-OC-001
- Status last verified
- Feb 2023
- First submitted
- 25 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zimberelimab Combined With Metformin in the Treatment of Recurrent Ovarian Clear Cell Carcinoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT05759312
- Acronym / sponsor ID
- zsfud-OC-001
- Conditions
- Ovarian Clear Cell Carcinoma
- Keywords
- Ovarian Clear Cell Carcinoma, Immune Checkpoint Inhibitor, Metformin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zimberelimab plus metformin | Experimental | Drug: Zimberelimab, Drug: Metformin HydrochloridePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZimberelimabAlso: Anti PD-1Zimberelimab 240mg IV every 2 weeks | Drug | zimberelimab plus metformin |
| Metformin HydrochlorideAlso: MetforminMetformin 2000mg PO QD | Drug | zimberelimab plus metformin |
Primary outcome
Objective response rate
Time frame: 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
6 secondary outcomes
Progression-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Disease control rate
Time frame: Up to 2 years
Duration of response
Time frame: Up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 2 years
Patterns of subsequent recurrence
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Ovarian Clear Cell Carcinoma
Active, not recruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Ovarian Clear Cell Carcinoma, Gynecologic Cancer
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
Not yet recruitingPhase 2
A Phase II Investigator-initiated Trial of Sacituzumab Tirumotecan Plus Pembrolizumab in Patients With Recurrent ovarIan Clear Cell Carcinoma Previously Treated With Platinum-based Chemotherapy（NCCH2407/MK014）
Ovarian Clear Cell Carcinoma
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Libing Xiang principal investigator
Department of Gynecologic Oncology, Zhongshan Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zimberelimab and Metformin Hydrochloride in people with Ovarian Clear Cell Carcinoma, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Libing Xiang (862164041990 ext. 2801, xiang.libing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.