Clinical Trial on Combination Immunotherapy for Advanced Kidney Cancer
Sponsor: Michael B. Atkins, MD
ClinicalTrials ID:NCT05928806
This study is testing a new combination of immunotherapy drugs to see if they are safe and effective for patients with advanced kidney cancer that has spread. The trial compares two different drug combinations in patients who have not received prior treatment for their cancer.
Patient Parameters
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Program Overview
This clinical trial is exploring the safety and effectiveness of two different combinations of immunotherapy drugs for patients with advanced kidney cancer that has spread (metastatic renal cell carcinoma). The study will include 120 patients who have not received any previous treatment for their cancer. Participants will be randomly assigned to one of two groups: one group will receive the drugs botensilimab and balstilimab, while the other group will receive ipilimumab and nivolumab. The treatment will continue until the cancer progresses, side effects become too severe, or for a maximum of 96 weeks.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced kidney cancer with a clear cell component that cannot be treated with surgery or radiation.
- Have measurable cancer as shown by scans.
- Be classified into one of the risk groups based on specific health factors.
- Provide a tumor tissue sample from a metastatic site for testing.
- Have adequate organ function based on blood tests.
- HIV positive patients may be eligible if their condition is well-controlled.
- Patients with hepatitis B or C may be eligible if the virus is not active.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Men must agree to use contraception if they are sexually active with women of childbearing potential.
Exclusion Criteria
- Have received prior treatment for kidney cancer.
- Have active brain metastases that have not been treated.
- Have severe allergies to similar drugs or a history of severe immune reactions.
- Require ongoing treatment with steroids or other immune-suppressing drugs.
- Have an active autoimmune disease that required treatment in the past two years.
- Have uncontrolled heart disease or other serious medical conditions.
- Are pregnant or breastfeeding.
- Have had a major surgery less than 28 days before starting the study.
- Have had another active cancer within the past two years, except for certain skin cancers or other localized cancers that have been treated.
- Have received a live vaccine within 30 days before starting the study.
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