A Phase 2 Study of Ivonescimab (Bispecific Antibody Against PD1 and VEGF) For the Treatment of Endometrial (EC) and Cervical (CC) Cancers

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ 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 120 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.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Maria Rubinstein, MD
medgmoclinicaltrials@mskcc.org
646-888-6954
Backup
Vicky Makker, MD
medgmoclinicaltrials@mskcc.org
646-888-4224
Time Frame
Start Date: 2025-04-04
Estimated Completion Date: 2027-04-04
Participants
Target number of participants: 50
Treatments
Experimental: Ivonescimab in People With Endometrial Cancer
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.
Experimental: Ivonescimab in People With Cervical Cancer
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.
Related Therapeutic Areas
Sponsors
Collaborators: Summit Therapeutics
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov