Evolocumab + Nivolumab for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs: evolocumab (Repatha, a cholesterol-lowering medication) and nivolumab (Opdivo, an immunotherapy drug). The aim is to determine if they can control kidney cancer that has spread and does not respond to standard treatments. Researchers also seek to ensure the safety of this drug duo for participants. This trial suits individuals with kidney cancer that includes a clear-cell component, who have tried other treatments without success, and have no recent side effects from cancer treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot receive any other systemic therapy for kidney cancer while participating in this trial. If you are on chemotherapy, immunotherapy, or other experimental cancer therapy, you must stop at least 2 weeks before starting the study treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any other systemic therapy for kidney cancer while participating. If you are on chemotherapy, immunotherapy, or other experimental cancer therapy, you must stop at least 2 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both evolocumab and nivolumab have been tested in people, each with its own safety profile. Evolocumab is usually well-tolerated and is already approved to lower cholesterol, indicating a proven safety record. Nivolumab treats various cancers, including kidney cancer. Past studies have linked nivolumab to serious side effects like pneumonia and trouble swallowing, but these occur in only a small number of patients.
The combination of evolocumab and nivolumab is still under study specifically for kidney cancer. However, existing information on each drug alone offers some reassurance. This trial is in Phase 2, focusing on the safety of this combination for patients, and researchers have already collected initial safety data from earlier phases.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Evolocumab combined with Nivolumab for kidney cancer because this duo offers a novel approach. Unlike traditional treatments like surgery, targeted therapies, and other immunotherapies, this combination leverages different mechanisms. Evolocumab is a monoclonal antibody that targets PCSK9, primarily used to lower cholesterol, but here it may enhance immune response. Nivolumab, another monoclonal antibody, blocks the PD-1 pathway, helping the immune system attack cancer cells more effectively. Together, they could offer a new way to bolster the body's own defenses against cancer, potentially leading to improved outcomes for patients.
What evidence suggests that evolocumab and nivolumab might be effective for kidney cancer?
Research has shown that nivolumab, a type of immunotherapy, extends survival in people with advanced kidney cancer compared to other treatments. Patients taking nivolumab lived longer than those taking everolimus, another cancer drug. In this trial, participants will receive a combination of evolocumab and nivolumab. Evolocumab, typically used to lower cholesterol, is under study for its potential to enhance the immune system's ability to fight cancer. The combination of evolocumab and nivolumab aims to strengthen the body's defense against kidney cancer. Early studies suggest that this combination could improve treatment outcomes for people with metastatic renal cell carcinoma, a form of kidney cancer that has spread.12346
Who Is on the Research Team?
Eric Jonasch, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with metastatic renal cell carcinoma, a type of kidney cancer that has spread and doesn't respond to treatment. Participants should meet specific health criteria set by the researchers but these aren't detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive evolocumab and nivolumab on Day 1 of each cycle (every 4 weeks). Evolocumab is given as an injection under the skin, and nivolumab is given by vein over about 60 minutes.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Evolocumab
- Nivolumab
Evolocumab is already approved in United States, European Union for the following indications:
- To reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease
- Familial hypercholesterolemia
- High-risk patients with LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL on maximally tolerated statin therapy ± ezetimibe
- Primary hypercholesterolaemia and mixed dyslipidaemia
- Homozygous familial hypercholesterolaemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Cancer Prevention Research Institute of Texas
Collaborator
United States Department of Defense
Collaborator