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Monoclonal Antibodies

Evolocumab + Nivolumab for Kidney Cancer

Phase 2

Waitlist Available

Led By Eric Jonasch, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undetectable HBV viral load on suppressive therapy if indicated

ECOG performance status of ≤ 1 OR KPS ≥ 70%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial will test if a combination of evolocumab and nivolumab can help treat advanced kidney cancer that has spread and not responded to other treatments. The study will also look at

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests whether combining two drugs, Evolocumab and Nivolumab, can manage advanced kidney cancer effectively. It also examines the safety profile of this drug combination in treating the disease.See study design

What are the potential side effects?

While not specified here, common side effects for immunotherapies like Nivolumab include fatigue, skin issues, and inflammation-related symptoms; Evolocumab may cause muscle pain or reactions at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hepatitis B virus is undetectable with treatment.

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I am mostly self-sufficient and can carry out daily activities.

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I had hepatitis C but it's either cured or undetectable now.

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My kidney cancer diagnosis includes clear-cell characteristics.

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I have received treatments targeting blood vessel growth or immune system in my cancer.

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I am 18 years old or older.

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My brain metastases have not worsened after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evolocumab + NivolumabExperimental Treatment2 Interventions

If you are found to be eligible to take part in this study, you will receive evolocumab and nivolumab on Day 1 of each cycle (every 4 weeks). Evolocumab will be given as an injection under the skin. Nivolumab will be given by vein over about 60 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Evolocumab

2011

Completed Phase 4

~13010

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,499 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,642 Previous Clinical Trials

4,130,113 Total Patients Enrolled

Cancer Prevention Research Institute of TexasOTHER

50 Previous Clinical Trials

98,428 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks of combining Evolocumab with Nivolumab for individuals?

"Based on our evaluation at Power, the safety rating for Evolocumab + Nivolumab is 2 out of 3. This assessment derives from ongoing Phase 2 trials where existing data supports safety measures without conclusive evidence regarding efficacy."

Answered by AI

Are there any current opportunities for potential participants to enroll in this trial?

"According to clinicaltrials.gov, the current status of this trial does not involve participant recruitment. It was initially registered on July 31st, 2024 and last modified on February 21st, 2024. Despite its inactive enrollment status, there are currently 2633 other studies actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)

2024. "A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06284564.

All > Metastatic Renal Cell Carcinoma