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Tyrosine Kinase Inhibitor
Cabozantinib + Nivolumab + Ipilimumab for Kidney Cancer
Phase 2
Recruiting
Led By Bradley McGregor, MD
Research Sponsored by Bradley A. McGregor, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
ECOG performance status ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up defined as the percentage of patients with partial (pr) or complete response (cr) as best overall response according to recist 1.1 by investigator assessment up to 21 months
Awards & highlights
Study Summary
This trial will study whether cabozantinib, nivolumab and ipilimumab can safely and effectively treat advanced renal cell carcinoma.
Who is the study for?
Adults with advanced or metastatic non-clear cell renal cell carcinoma (nccRCC) who haven't had certain previous treatments can join. They must be able to provide a fresh tumor biopsy, use contraception, and have normal organ/marrow function. Excluded are those with specific heart diseases, autoimmune conditions, lung fibrosis, bleeding disorders without therapeutic anticoagulation, severe infections or on strong CYP3A4 inhibitors/inducers.Check my eligibility
What is being tested?
The trial is testing the combination of Cabozantinib with immunotherapy drugs Nivolumab and Ipilimumab for effectiveness in slowing kidney cancer growth. Participants will receive all three medications to see if they work better together than current standard treatments.See study design
What are the potential side effects?
Possible side effects include liver problems, diarrhea, fatigue, skin rash and itching. There may also be risks of immune-related issues like inflammation in organs such as lungs or intestines and potential hormonal gland problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
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My kidney cancer cannot be removed by surgery and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ defined as the percentage of patients with partial (pr) or complete response (cr) as best overall response according to recist 1.1 by investigator assessment up to 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~defined as the percentage of patients with partial (pr) or complete response (cr) as best overall response according to recist 1.1 by investigator assessment up to 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
"Number of Participants with TreatmentRelated Adverse Events as Assessed by CTCAE version 5.
Duration of response (DOR)
Objective response rate (ORR)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment3 Interventions
Eligible patients will be enrolled and receive treatment with
Cycle 1-4 (cycles of 21 days)
Cabozantinib predetermined protocol dosage po daily
Nivolumab predetermined protocol dosage via IV every 3 weeks
Ipilimumab predetermined protocol dosage via IV every 3 weeks
After the first four cycles of therapy,
Cabozantinib determined protocol dosage po daily
Nivolumab predetermined protocol dosage via IV every 3 weeks (cycles of 28 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Bradley A. McGregor, MDLead Sponsor
2 Previous Clinical Trials
39 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,004 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,491 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken cancer drugs or tyrosine kinase inhibitors in the last 4 weeks.I have a bleeding disorder not caused by blood thinners.I have had a previous transplant of an organ or stem cells from a donor.You have a history of autoimmune disease.My organ and bone marrow functions are normal.I am not taking any strong drugs that affect liver enzymes.I cannot receive medications through an IV.I have a history of specific lung conditions or signs of lung inflammation on a recent chest CT.I have been treated with cabozantinib before.I will have a new tumor biopsy before starting treatment unless it's unsafe.I am 18 years old or older.I have been treated with CD137 agonists and immune checkpoint inhibitors before.I agree to use birth control during the study.You have more than 1.5 grams of protein in your urine over a 24-hour period.I have a history of certain infectious diseases.I am fully active and can carry on all pre-disease activities without restriction.You have a disease that can be measured using a specific set of guidelines.I have a condition that prevents my body from absorbing nutrients properly.I have serious heart problems.My kidney cancer cannot be removed by surgery and has spread.I haven't taken any immunosuppressive drugs in the last 2 weeks.I cannot swallow pills.I have a serious stomach or intestine condition that could lead to bleeding or a tear.I have received treatments for my condition before.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What ailments has Cabozantinib been found to successfully alleviate?
"Cabozantinib is often the treatment of choice for those with unresectable melanoma, but can also prove useful in fighting squamous cell carcinoma and high-risk recurrent illness."
Answered by AI
How many test subjects are participating in this research endeavor?
"Affirmative, the clinicaltrials.gov portal states that this medical experiment is now inviting participants to join. It was initially uploaded on November 5th 2020 and modified most recently on August 1st 2022; it needs 60 volunteers from 4 distinct locations."
Answered by AI
What other research has been conducted related to Cabozantinib?
"At the moment, 841 trials for cabozantinib are underway with 94 of those in the advanced Phase 3. Pittsburgh, Pennsylvania is a notable research hub for this drug though it can be found across 46024 sites worldwide."
Answered by AI
Has the U.S. Food and Drug Administration sanctioned Cabozantinib for medical usage?
"Our internal review has given cabozantinib a score of 2, which reflects the fact that this Phase 2 trial has data backing its safety but not yet demonstrating efficacy."
Answered by AI
Are any new participants currently being recruited for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this clinical trial is currently accepting participants and was originally posted on November 5th 2020. The study has recently been revised on August 1st 2022, with a total of 60 patients sought out from 4 centres across the US."
Answered by AI
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