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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
No Placebo-Only Group
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 belowSelect...
I have had treatments for kidney cancer that has spread, but not with anti-CTLA-4, cabozantinib, or MET inhibitors.
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I can take care of myself and am up and about more than half of the day.
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I am 18 years old or older.
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I have kidney cancer that has spread to my brain and can be measured.
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I am not a candidate for immediate surgery or radiation for my condition.
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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.
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My side effects from cancer treatment are mild, except for hair loss.
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I do not have significant liver disease such as hepatitis or cirrhosis.
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I have not had severe infections or been hospitalized for them in the last 4 weeks.
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I need immediate brain surgery or radiation due to my cancer symptoms.
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I have a specific type of blood cancer, such as acute leukemia or Burkitt lymphoma.
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I need immediate surgery or radiation for cancer outside my brain.
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I have active tuberculosis.
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I have not had any other cancers in the last 5 years.
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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
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420
Cabozantinib
2020
Completed Phase 2
~2360
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,686 Previous Clinical Trials
4,129,787 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,569 Total Patients Enrolled
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread to the lining of my brain and spinal cord.I have never had lung conditions like pulmonary fibrosis or pneumonitis.My side effects from cancer treatment are mild, except for hair loss.I do not have significant liver disease such as hepatitis or cirrhosis.I have not had severe infections or been hospitalized for them in the last 4 weeks.I agree to use effective birth control during and for 12 months after treatment.I need immediate brain surgery or radiation due to my cancer symptoms.The size of the tumor is between 5mm and 30mm, as seen on an MRI scan with a special dye.I haven't taken corticosteroids in the last 10 days, except for allowed exceptions.I have a specific type of blood cancer, such as acute leukemia or Burkitt lymphoma.You cannot have an MRI because you have a metal implant or are allergic to gadolinium contrast.I have had treatments for kidney cancer that has spread, but not with anti-CTLA-4, cabozantinib, or MET inhibitors.I have an autoimmune disease, but it's not one of the exceptions listed.I have not taken antibiotics in the last 2 weeks.I haven't had radionuclide therapy in the last 6 weeks.I do not have any health conditions that could interfere with the study treatment.I can take care of myself and am up and about more than half of the day.I need immediate surgery or radiation for cancer outside my brain.I have active tuberculosis.You are expected to live for more than 12 weeks.You are expected to live for less than 3 months.I haven't had cancer treatment in the last 4 weeks, except for some allowed therapies.You are allergic to synthetic human antibodies.I have a history of HIV or active hepatitis B/C, with an exception.I haven't had signs of infection in the last 2 weeks.I have not had any other cancers in the last 5 years.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I am 18 years old or older.My side effects from previous treatments are mild or gone.I have kidney cancer that has spread to my brain and can be measured.Your blood clotting tests should be within a certain range before you can join the study.I am not a candidate for immediate surgery or radiation for my condition.My recent blood tests show my organs are functioning well.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I have brain-related symptoms that don't affect my daily activities and haven't taken steroids for 10 days.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab
- Group 2: Ipilimumab
- Group 3: Cabozantinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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