Phase II Study on Improving Immunotherapy with Evolocumab and Nivolumab for Patients with Metastatic Kidney Cancer (BOOST-RCC)
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06284564
This clinical trial is exploring whether the combination of evolocumab and nivolumab can effectively control advanced kidney cancer that has spread and is resistant to other treatments. The study will also assess the safety of this drug combination.
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Program Overview
The aim of this study is to find out if using evolocumab and nivolumab together can help manage metastatic kidney cancer that hasn't responded to previous treatments. Researchers will also look at how safe this combination is for patients.
Description
The main goals of this study are to see how well the combination of evolocumab and nivolumab works in shrinking tumors in patients with advanced kidney cancer that hasn't responded to other treatments. The study will also check for any side effects and how long patients can live without the cancer getting worse. Researchers will also explore how the treatment affects certain immune cells and cholesterol levels in the blood.
Participants will be monitored for any adverse effects and the overall effectiveness of the treatment. The study will also track how long patients live after treatment and how long they remain free of disease progression. Additionally, researchers will examine changes in the tumor environment and blood markers before and after treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with kidney cancer that has spread, with a clear-cell component.
- Previously treated with VEGF or immunotherapy drugs, or have refused standard treatments.
- Aged 18 years or older.
- Signed informed consent to participate in the study.
- Good overall health with a performance status score of 0 or 1.
- Adequate organ and bone marrow function based on specific blood tests.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
- Men must use effective contraception and cannot donate sperm during the study.
- For those with hepatitis B, the virus must be under control with treatment.
- Those with hepatitis C must have been treated and cured, or have an undetectable viral load if still on treatment.
- Treated brain metastases are allowed if stable and not progressing.
- Other cancers are allowed if they do not interfere with the study treatment.
Exclusion Criteria
- Recent chemotherapy, immunotherapy, or experimental cancer treatment within 2 weeks before starting the study.
- Not fully recovered from previous cancer treatment side effects, except for hair loss and stable hormone-related conditions.
- Receiving other systemic therapy for kidney cancer.
- Symptomatic brain or spinal cord metastases requiring ongoing treatment.
- Allergic reactions to study drugs or similar products.
- Active infection needing treatment within 14 days before starting the study.
- Severe heart or lung conditions, uncontrolled high blood pressure.
- Any other medical or psychiatric conditions that could interfere with the study.
- Pregnant or breastfeeding women are not eligible.
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