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Tyrosine Kinase Inhibitor

Cabozantinib + Nivolumab + Radiation for Metastatic Kidney Cancer

Phase 1

Recruiting

Led By Ritesh Kotecha, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥18 years

Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen for definitive diagnosis of RCC

Must not have

Significant cardiovascular disease, uncontrolled hypertension, or QTcF > 500 msec within 28 days before the first dose of study treatment

Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combo of drugs and radiation therapy to treat kidney cancer that has spread to the brain, to see if it's safe and has few side effects. It will also measure QoL.

Who is the study for?

This trial is for adults with renal cell carcinoma that has spread to the brain. Participants must be over 18, have a good performance status (able to carry out daily activities), and agree to use effective contraception if necessary. They should not have had certain treatments recently, like whole brain radiotherapy or experimental drugs within the last month, and should not need major surgery during the study.

What is being tested?

The study tests a combination of cabozantinib and nivolumab with stereotactic radiosurgery on patients with kidney cancer in the brain. It aims to assess safety, effectiveness, and impact on quality of life through questionnaires.

What are the potential side effects?

Potential side effects may include fatigue, high blood pressure, diarrhea, liver issues, mouth sores, hand-foot syndrome (redness and pain in hands/feet), immune-related reactions such as inflammation in organs or skin rash.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can provide a tissue sample for my kidney cancer diagnosis.

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My kidney cancer cannot be removed by surgery and is not chromophobe type.

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I have small, treated brain tumors.

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I can carry out normal activities with minimal symptoms.

Exclusion Criteria

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

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I do not have serious heart disease, uncontrolled high blood pressure, or a specific heart rhythm issue.

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I have a serious wound that won't heal, an active ulcer, or an untreated broken bone.

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My cancer is growing into or around major blood vessels.

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I have had a solid organ or bone marrow transplant.

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I do not have any serious ongoing infections.

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I cannot swallow pills.

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I have lung lesions or disease in my airways.

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I have been treated with cabozantinib for kidney cancer.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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I have high calcium levels that need ongoing treatment.

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I haven't had major surgery in the last 14 days and don't expect to need one during the study.

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I am currently taking blood thinners.

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I have untreated or symptomatic thyroid issues.

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I need IV fluids, nutrition, or tube feeding due to stomach or intestine blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

percent of enrolled patients who are able to tolerate treatment

Secondary study objectives

objective response rate (ORR)

rate of CNS adverse events

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: Cabozantinib and Nivolumab With Radiation TherapyExperimental Treatment3 Interventions

Patients being newly initiated on cabo/nivo will be started on with cabozantinib 40 mg PO daily and nivolumab 480 mg IV day Q4 weeks o Dose de-escalation of cabozantinib for toxicity will be allowed per prespecified toxicity dose levels Radiation will be stereotactic radiosurgery, delivered over 1-5 fractions with a total dose of 18-30Gy depending on fractionation schedule per the discretion of the treating radiation oncologist. Standard institutional regimens such as 18-24 Gy in a single fraction, 24-27 Gy in three fractions, and 25-30 Gy in five fractions are permissible.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Stereotactic Radiosurgery (SRS)

2012

Completed Phase 2

~280