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New treatment option for Endometrial Cancer
Official title A Study of Ivonescimab in People With Endometrial and Cervical Cancers
ClinicalTrials.gov ID: NCT06925724
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The researchers are doing this study to find out if ivonescimab is an effective treatment for people with endometrial cancer (EC) and/or cervical cancer (CC). The researchers will also look at whether the study drug is safe and causes few or mild side effects in participants.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically confirmed metastatic/recurrent endometrial or cervical cancer that has progressed after treatment with at least one platinum-based...
- Endometrial cancer histologies can include: endometrioid, serous, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma...
- Cervical cancer histologies can include: squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma
- Measurable disease per RECIST v 1.1 criteria
- people must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
You likely can't join if
- Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first...
- 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...
- Gastrointestinal bleeding
- Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic...
- Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
See the full eligibility criteria
Who can join
- Histologically confirmed metastatic/recurrent endometrial or cervical cancer that has progressed after treatment with at least one platinum-based regimen.
- Endometrial cancer histologies can include: endometrioid, serous, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma NOS, and carcinosarcoma.
- Cervical cancer histologies can include: squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma
- Measurable disease per RECIST v 1.1 criteria
- people 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) ≥ 50 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
What rules you out
- 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...
- 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:
- Gastrointestinal bleeding
- Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.
- Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
- Need for new therapeutic anticoagulant therapy within 14 days prior to enrollment. Note: Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior...
- History of major diseases before enrollment, specifically:
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or vascular disease that required hospitalization within 12 months prior to enrollment, or...
- History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment.
- History of arterial thromboembolic event, venous thromboembolic event, , transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to enrollment.
- Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection...
- Imaging during the screening period shows that the patient has:
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer
- Radiographic evidence of intratumor cavitation
- 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 a. Note: Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy should require the patient be on a suppressive antiviral therapy prior to...
- Active/Acute Hepatitis C infection a. Note: Patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution should be eligible.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.