← Back to Search

Checkpoint Inhibitor, Tyrosine Kinase Inhibitor

Triple Drug Therapy for Kidney Cancer with Brain Metastases

Phase 2

Recruiting

Led By Jianbo Wang

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

Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

Must not have

Patients with Leptomeningeal disease

AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing the combination of three drugs to treat patients with renal cell carcinoma that has spread to the brain.

Who is the study for?

This trial is for adults with untreated brain metastases from renal cell carcinoma. Participants should have a measurable brain lesion, be in good physical condition (ECOG 0-2), and not need immediate local therapy. They must have normal organ function and agree to contraception if applicable. Exclusions include recent radiation or systemic cancer treatments, significant liver disease, metal implants preventing MRI scans, symptomatic brain metastases needing urgent treatment, certain infections or vaccinations recently, other cancers within the last 5 years, autoimmune diseases.

What is being tested?

The study tests a combination of Nivolumab (an immunotherapy drug), Ipilimumab (another immunotherapy), and Cabozantinib (a medication targeting specific proteins in cancer cells) on patients who haven't treated their kidney cancer's spread to the brain yet. It aims to see how well this combo works together.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in organs such as lungs or intestines; skin issues; hormone gland problems; fatigue; liver enzyme changes; high blood pressure from Cabozantinib; diarrhea; mouth sores and hand-foot syndrome.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had treatments for kidney cancer that has spread, but not with anti-CTLA-4, cabozantinib, or MET inhibitors.

Select...

I can take care of myself and am up and about more than half of the day.

Select...

I am 18 years old or older.

Select...

I have kidney cancer that has spread to my brain and can be measured.

Select...

I am not a candidate for immediate surgery or radiation for my condition.

Select...

My recent blood tests show my organs are functioning well.

Exclusion Criteria

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

Select...

I have cancer that has spread to the lining of my brain and spinal cord.

Select...

My side effects from cancer treatment are mild, except for hair loss.

Select...

I do not have significant liver disease such as hepatitis or cirrhosis.

Select...

I have not had severe infections or been hospitalized for them in the last 4 weeks.

Select...

I need immediate brain surgery or radiation due to my cancer symptoms.

Select...

I have a specific type of blood cancer, such as acute leukemia or Burkitt lymphoma.

Select...

I need immediate surgery or radiation for cancer outside my brain.

Select...

I have active tuberculosis.

Select...

I have not had any other cancers in the last 5 years.

Select...

I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: NivolumabExperimental Treatment3 Interventions

by vein every 3 weeks for 4 doses

Group II: IpilimumabExperimental Treatment3 Interventions

by vein over 30 minutes every 3 weeks for 4 doses

Group III: CabozantinibExperimental Treatment3 Interventions

tablets by mouth 1 time every day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Ipilimumab

2014

Completed Phase 3

~3140

Cabozantinib

2020

Completed Phase 2

~1760

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,678 Previous Clinical Trials

4,125,605 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,661 Total Patients Enrolled

ExelixisIndustry Sponsor

119 Previous Clinical Trials

19,879 Total Patients Enrolled

Media Library

Nivolumab, Ipilimumab, Cabozantinib (Checkpoint Inhibitor, Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05048212 — Phase 2

Kidney Cancer Research Study Groups: Nivolumab, Ipilimumab, Cabozantinib

Kidney Cancer Clinical Trial 2023: Nivolumab, Ipilimumab, Cabozantinib Highlights & Side Effects. Trial Name: NCT05048212 — Phase 2

Nivolumab, Ipilimumab, Cabozantinib (Checkpoint Inhibitor, Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05048212 — Phase 2

~15 spots leftby Dec 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.