Phase II Study of Ivonescimab for Patients with Advanced Clear Cell Kidney Cancer Who Have Had Previous Treatments
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06940518
This clinical trial is exploring whether the drug ivonescimab can help control advanced clear cell kidney cancer in patients who have already received other treatments. The study will also assess the safety of ivonescimab and its effects on survival and disease progression.
Patient Parameters
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Program Overview
The aim of this study is to find out if ivonescimab can effectively manage advanced clear cell renal cell carcinoma (ccRCC) in patients who have already undergone at least one previous treatment. Researchers will evaluate how well the cancer responds to the drug and monitor patients for any side effects. The study will also look at how long patients live, how long they remain free from disease progression, and how long the response to the treatment lasts.
Description
This study focuses on patients with advanced clear cell kidney cancer who have already tried other treatments. The main goal is to see if ivonescimab can help control the cancer by measuring the response rate and disease control rate at 24 weeks. Researchers will also monitor the safety of ivonescimab, looking at overall survival, progression-free survival, and any side effects that occur during the study. Participants will receive ivonescimab as a monotherapy, meaning it will be the only treatment given during the trial.
Eligibility Criteria
Exclusion Criteria
- Cannot have had any other cancers in the past 2 years, except for certain types that are not likely to spread or cause death.
- No major surgeries or serious injuries within 4 weeks before starting the study, and no plans for major surgeries soon after starting.
- Cannot have high blood pressure that is not controlled by medication.
- Cannot have a history of significant bleeding issues or conditions that increase the risk of bleeding.
- Cannot have had major heart problems or certain other serious health issues within the past year.
- Cannot have had certain types of blood clots or strokes within the past year.
- Cannot have active or untreated brain metastases or need brain radiation soon after starting the study.
- Cannot have active inflammatory bowel disease or other chronic inflammatory conditions.
- Cannot be taking other experimental treatments.
- Cannot have active autoimmune diseases requiring treatment.
- Cannot have had organ or stem cell transplants.
- Cannot have had severe infections recently.
- Cannot have uncontrolled fluid buildup in the body.
- Cannot have allergies to similar drugs.
- HIV-positive patients must have an undetectable viral load.
- Cannot have active hepatitis B or C infections unless controlled.
- Cannot have severe nerve damage.
- Pregnant or breastfeeding women cannot participate.
- Cannot have ongoing severe side effects from previous cancer treatments.
- Cannot have any other medical conditions that might interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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