Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Kidney Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07516366
This study is exploring whether using two immunotherapy drugs, botensilimab and balstilimab, before surgery can safely and effectively treat high-risk clear cell kidney cancer that hasn't spread. The goal is to see if these drugs can help the immune system attack the cancer and make surgery more successful.
Patient Parameters
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Program Overview
This phase II trial is testing the effects of two immunotherapy drugs, botensilimab and balstilimab, given before surgery to treat patients with high-risk clear cell kidney cancer that hasn't spread. The standard treatment usually involves surgery to remove the kidney or part of it. These drugs may help the immune system fight the cancer and stop it from growing. The study aims to find out if using these drugs before surgery is safe and effective for patients with this type of cancer.
Description
The main goal of this study is to see if using botensilimab and balstilimab before surgery is safe and feasible for patients with high-risk clear cell kidney cancer that hasn't spread. Researchers will check if patients can have surgery on time after receiving these drugs.
Secondary goals include:
- Checking the safety of these drugs using standard criteria for side effects.
- Evaluating any surgical complications using a specific classification system.
- Measuring how well the primary tumor responds to the treatment.
- Assessing the percentage of patients who have a major or partial response in the tumor.
- Monitoring disease-free survival and rates of cancer spread or return after treatment.
Exploratory goals include:
- Studying the relationship between certain proteins and immune cells in the tumor and treatment outcomes.
- Examining genetic changes and their link to treatment results.
- Analyzing immune cells and proteins in the blood before and after treatment.
- Using blood tests to detect minimal residual disease as a marker of treatment response.
- Investigating the link between a specific protein in the blood and treatment outcomes.
Patients will receive botensilimab and balstilimab through an IV on specific days over several weeks. Surgery to remove the kidney or part of it will occur 12-16 weeks after starting treatment. Blood samples and CT scans will be taken throughout the study. After treatment, patients will have follow-up visits every 3 months for up to a year.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of high-risk clear cell kidney cancer that hasn't spread.
- Cancer must be resectable, meaning it can be surgically removed.
- Must be 18 years or older.
- Must have a good performance status, meaning they can carry out daily activities with minimal assistance.
- Must be suitable for surgery to remove the kidney or part of it.
- Must have adequate blood cell counts and organ function.
- HIV-positive patients must have an undetectable viral load.
- Hepatitis B and C patients must have controlled or cured infections.
- Must not have any other cancer that could interfere with the study.
- Must agree to use effective birth control during and after the study.
- Must be able to understand and sign a consent form.
- Must provide a pre-treatment tumor sample.
Exclusion Criteria
- Cancer that has spread beyond the kidney.
- Not fully recovered from previous cancer treatments.
- Currently taking other investigational drugs.
- Allergic to similar drugs as botensilimab or balstilimab.
- Have uncontrolled illnesses that make participation risky.
- Pregnant or breastfeeding women.
- No clear cell component in kidney biopsy.
- Previous treatment with certain immune therapies.
- Recent major surgery.
- Active or recent autoimmune diseases requiring treatment.
- Certain heart conditions or abnormal heart rhythms.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University Cancer Center LAO | 06520 | New Haven | Connecticut |
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