← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

I have small, treated brain tumors.

Select...

I can carry out normal activities with minimal symptoms.

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

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

Primary outcome measures

percent of enrolled patients who are able to tolerate treatment

Secondary outcome measures

objective response rate (ORR)

rate of CNS adverse events

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 240 mg IV Q2 weeks Dose de-escalation of cabozantinib for toxicity will be allowed per prespecified toxicity dose levels A switch to nivolumab 480mg IV Q4 weeks will be allowed starting C3 per investigator discretion. 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

Stereotactic Radiosurgery (SRS)

2012

Completed Phase 2

~240

Nivolumab

2014

Completed Phase 3

~4750

Cabozantinib

2020

Completed Phase 2

~1760

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,878 Total Patients Enrolled

ExelixisIndustry Sponsor

117 Previous Clinical Trials

19,531 Total Patients Enrolled

Ritesh Kotecha, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

42 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 is the current enrollment number for this clinical trial?

"Affirmative. Clinicaltrials.gov has published data indicating that the clinical trial, which was initially advertised on November 10th 2023, is in search of participants at this time. At 7 different medical facilities, a total of 20 patients are required to be enrolled for the study."

Answered by AI

Are there any vacancies presently available for enrollment in this clinical trial?

"Clinicaltrials.gov reveals that patient recruitment for this medical trial is currently underway; the study was initially published on November 10th 2023 and has been revised since then."

Answered by AI

To what extent can the combination of Cabozantinib and Nivolumab with Radiation Therapy be considered safe for individuals?

"Our team at Power have assigned Cabozantinib and Nivolumab With Radiation Therapy a score of 1, considering it is currently in Phase 1 trials. This indicates limited evidence to support its efficacy or safety."

Answered by AI

Are there any North American sites at which this research is being conducted?

"There are 7 sites that are currently running this trial. Of these, Memorial Sloan Kettering Cancer Suffolk - Commack in Commack and both the Harrison and New york centres of Memorial Sloan Kettering Westchester are relevant to all protocol activities. Additionally, there exist 4 other locations where the investigational treatment is taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Cabozantinib and Nivolumab With Radiation Therapy for People With Renal Cell Carcinoma That Has Spread to the Brain

2023. "A Study of Cabozantinib and Nivolumab With Radiation Therapy for People With Renal Cell Carcinoma That Has Spread to the Brain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132945.