A Study of Ivonescimab in People With Endometrial and Cervical Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ivonescimab
DrugIvonescimab 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)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Ivonescimab in People With Endometrial CancerExperimental treatment 1 intervention
Group B: Ivonescimab in People With Cervical CancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Time frame
27 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Summit Therapeutics
Collaborator
Source ClinicalTrials.gov