A Study of Ivonescimab in People With Endometrial and Cervical Cancers

NCT06925724 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Endometrial Cancer; Cervical Cancer

Keywords

Ivonescimab; 25-007

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

  27 weeks

Study Arms (2)

Ivonescimab in People With Endometrial Cancer

EXPERIMENTAL

Study treatment will be given sequentially on the first day of each cycle in a 3-week dosing cycle: Ivonescimab will be administered as 20 mg/kg IV (a fixed dose of 3200 mg for ivonescimab should be used for patients ≥ 160 kg), Q3W administered for 60 minutes (± 10 minutes). The total duration of ivonescimab treatment is up to 24 months.

Drug: Ivonescimab

Ivonescimab in People With Cervical Cancer

EXPERIMENTAL

Study treatment will be given sequentially on the first day of each cycle in a 3-week dosing cycle: Ivonescimab will be administered as 20 mg/kg IV (a fixed dose of 3200 mg for ivonescimab should be used for patients ≥ 160 kg), Q3W administered for 60 minutes (± 10 minutes). The total duration of ivonescimab treatment is up to 24 months.

Drug: Ivonescimab

Interventions

Ivonescimab DRUG

Ivonescimab will be administered as 20 mg/kg IV (a fixed dose of 3200 mg for ivonescimab should be used for patients ≥ 160 kg), Q3W administered for 60 minutes (± 10 minutes)

Ivonescimab in People With Cervical Cancer; Ivonescimab in People With Endometrial Cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Endometrial and Cervical Cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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) ≥ 50 mL/min using the Cockcroft-Gault formula

You may not qualify 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 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:
• 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 to randomization is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.
• 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 other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)
• 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 (partial colectomy or extensive small bowel resection) within 6 months prior to enrollmen
• Imaging during the screening period shows that the patient has:

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Summit Therapeutics: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Study Officials

• Maria Rubinstein, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Rubinstein, MD

CONTACT

646-888-6954; medgmoclinicaltrials@mskcc.org

Vicky Makker, MD

CONTACT

646-888-4224; medgmoclinicaltrials@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single arm, open-label, single-institution phase II trial.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 4, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)