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Tyrosine Kinase Inhibitor
Cabozantinib + Nivolumab for Kidney Cancer
Phase 2
Recruiting
Led By Tian Zhang, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow up until death or withdrawal, up to 36 months.
Awards & highlights
Study Summary
This trial tests if higher doses of cabozantinib or a combo of cabozantinib and nivolumab can help people with advanced kidney cancer who have been treated with cabozantinib.
Who is the study for?
Adults with advanced kidney cancer who've seen their disease progress after cabozantinib treatment can join. They must have used cabozantinib for over 6 months, be able to take it without severe side effects, and not be on certain medications or have specific health conditions. Participants need measurable cancer growth, good organ function, and a performance status indicating they can walk and care for themselves.Check my eligibility
What is being tested?
The trial is testing two approaches in patients whose kidney cancer has worsened despite previous treatment: one group will receive a high dose of cabozantinib alone, while the other will get a lower dose combined with nivolumab. The choice between these options depends on what dosage participants tolerated before.See study design
What are the potential side effects?
Cabozantinib may cause diarrhea, high blood pressure, fatigue, loss of appetite, weight loss and nausea. Nivolumab could lead to immune-related issues like inflammation in organs such as lungs or intestines; skin problems; hormonal gland changes; liver dysfunction; or infusion reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow up until death or withdrawal, up to 36 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up until death or withdrawal, up to 36 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival of cabozantinib or cabozantinib-nivolumab combination
Secondary outcome measures
Disease Control Rate of of cabozantinib or cabozantinib-nivolumab combination
Duration of response of of cabozantinib or cabozantinib-nivolumab combination
Objective Response Rate of cabozantinib or cabozantinib-nivolumab combination
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: cabozantinib + nivolumabExperimental Treatment2 Interventions
cabozantinib 40mg PO daily + nivolumab 480 mg IV every 4 weeks (q4w)
Group II: Cohort 1: Cabozantinib Dose EscalationExperimental Treatment1 Intervention
cabozantinib 80mg PO daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,515 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,699 Total Patients Enrolled
Tian Zhang, MDPrincipal InvestigatorUT Southwestern Medical Center
4 Previous Clinical Trials
348 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have another cancer needing treatment right now, except for certain exceptions.I can take care of myself but might not be able to do heavy physical work.I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.My brain metastases are treated and have been stable.I haven't taken steroids or immunosuppressants recently.My heart's electrical cycle is within a normal range.I cannot swallow pills.I cannot or do not want to receive treatments through an IV for Cohort 2.My advanced kidney cancer responded to cabozantinib treatment for over 6 months.My recent tests show my organs and bone marrow are functioning well.I agree to use birth control during and after the study.I am a woman capable of becoming pregnant.I have taken cabozantinib at 60mg or 40mg daily without severe side effects.I am 18 years old or older.I haven't had experimental cancer treatments in the last 4 weeks.I have recovered from previous cancer treatment side effects, or they are minor and stable.I have not had any major or minor surgeries recently.I am currently taking certain blood thinners.I have not received a live vaccine in the last 30 days.I do not have any severe ongoing illnesses affecting my heart, lungs, blood vessels, or stomach.I am currently being treated for an infection.I have previously been treated with cabozantinib/nivolumab.I have not had COVID-19 recently.I have previously been treated with a PD-1 or PD-L1 inhibitor.I have a history of specific lung, liver, kidney, hormone, wound healing, stomach, or transplant-related health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: cabozantinib + nivolumab
- Group 2: Cohort 1: Cabozantinib Dose Escalation
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.
Are any new participants being welcomed into this experiment?
"Clinicaltrials.gov reveals that this study, which was originally posted on September 1st 2023 and most recently adjusted on July 3rd 2023, is not currently actively recruiting patients. However, there are presently 2617 other trials searching for volunteers."
Answered by AI
Has the FDA endorsed Cohort 1: Cabozantinib Dose Escalation?
"The safety of Cohort 1: Cabozantinib Dose Escalation was appraised to be a 2 on account that this is Phase 2 clinical trial. Although there are data points supporting its security, no evidence has been found yet backing up its efficacy."
Answered by AI
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