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Monoclonal Antibodies

Evolocumab + Nivolumab for Kidney Cancer

Phase 2

Recruiting

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%

Must not have

Medical conditions, psychiatric condition, physical examination, or laboratory findings interfering with treatment

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any health issues that would interfere with the treatment.

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My high blood pressure is not under control.

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I am currently receiving systemic therapy for kidney cancer.

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I have not had an infection needing treatment in the last 14 days.

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I have severe symptoms of heart failure.

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I need medication for brain-related symptoms due to cancer spread.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5220