Ivonescimab for Endometrial and Cervical Cancers
This study is testing a medicine called ivonescimab in women with endometrial cancer or cervical cancer that has returned or spread after previous treatment with platinum-based chemotherapy. Researchers want to see if ivonescimab is an effective treatment and if it causes few or mild side effects. The main goal is to measure how many participants respond to the treatment (Overall Response Rate) after 27 weeks. The study is currently enrolling participants, with a plan for 50 women to join.
- Study design
- This study is for women aged 18 and older with advanced endometrial or cervical cancer. It is an interventional study, meaning participants will receive the study drug.
- What's involved
- Ivonescimab will be given intravenously (into a vein) every three weeks over 60 minutes. This treatment will continue for at least 27 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome of the study, overall response rate, will be measured at 27 weeks.
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NCT06925724
A Study of Ivonescimab in People With Endometrial and Cervical Cancers
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~50 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Ivonescimab
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over 27 weeks
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Maria Rubinstein, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed metastatic/recurrent endometrial or cervical cancer that has progressed after treatment with at least one platinum-based regimen.
Measurable disease per RECIST v 1.1 criteria
Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
All patients must have received at least 1 line of platinum-based therapy. Prior PD1 or VEGF therapy is allowed.
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤160/90 mmHg.
Have adequate laboratory values as defined in the following table:
Hematologic
Absolute neutrophil count (ANC) ≥1500/mm3 (≥1.5 × 103/µL)
Platelets ≥100,000/µL
Hemoglobin ≥9.0 g/dL
International Normalized Ratio (INR) ≤1.5
Renal
Creatinine clearance (CrCL) Urinalysis Creatinine clearance (CrCl) ≥ 30 mL/min using the Cockcroft-Gault formula
Urinalysis Urine protein \< 2+ (or 24 hour urine protein quantification \< 1.0 g)
Hepatic
Total bilirubin ≤1.5 ×ULN (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
AST and ALT ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
TSH TSH within normal limits. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal free T4 level is required.
Coagulation Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy, or prophylactic coagulation
Age ≥18 years at the time of informed consent.
Patients with treated brain metastases are eligible if follow-up brain imaging after CNS directed therapy shows no evidence of progression. Patients with treated brain metastasis should be excluded if they have any evidence of bleeding, or if they have large lesions at risk of bleeding ie \>1.5cm. Patients should also be off corticosteroids at the time of enrollment. Patients with untreated brain metastasis are excluded.
Not Pregnant and Not Nursing. If with childbearing potential, should have a negative urine pregnancy test at the time of screening.
Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab.
Must have clinical IMPACT data available, if data is not available, must have adequate tissue to available for clinical IMPACT. Patient will consent to 12-245 at enrollment if not previously completed.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion
Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.
Patient not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:
History of major diseases before enrollment, specifically:
Imaging during the screening period shows that the patient has:
Has participated in a study of an investigational agent and received cancer directed study therapy within 4 weeks prior to start of study treatment
Prolongation of QTc interval (Fredericia) to \>480 msec
Active/Acute Hepatitis B infection
Active/Acute Hepatitis C infection
Known intolerance to either of the study drugs (or any of the excipients)
History of organ allograft (subject has had an allogenic tissue/solid organ transplant)
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (up to 10 mg/d of prednisone or equivalent) may be approved after consultation with the study PI or Co-PI.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Patient with any prior immune related events (irAE) Grade 3 or higher that resulted in discontinuing or significant delay of dosing of immunotherapy
Has received a live-virus vaccination within 30 days of planned treatment start.
What this trial measures
- Overall response rate (ORR)27 weeks
Response Evaluation Criteria in Solid Tumors (RECIST v1.1).