Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Cabozantinib + Enfortumab Vedotin for Bladder Cancer
Phase 1
Recruiting
Led By Mehmet A Bilen, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor tissue samples must be available for submission prior to initiation of study treatment or patient must be willing to undergo repeat tumor biopsy
Must either have prior treatment with platinum-containing chemotherapy or be ineligible at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study completion (estimated 5 years)
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining cabozantinib with enfortumab vedotin to see if it is safe and effective in treating patients with urothelial cancer that has spread to nearby tissues or other parts of the body.
Who is the study for?
Adults with advanced or metastatic urothelial cancer, who have previously been treated with chemotherapy and checkpoint inhibitors. They must be in a stable condition, not pregnant, able to swallow tablets, and without serious recent illnesses or surgeries. Participants need measurable disease according to RECIST criteria and acceptable organ function tests.Check my eligibility
What is being tested?
The trial is testing the combination of Cabozantinib (an enzyme blocker that may stop tumor growth) and Enfortumab Vedotin (a monoclonal antibody linked to a toxin targeting cancer cells). It aims to determine the best dose and assess potential benefits/side effects for treating advanced urothelial cancer.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, digestive issues like nausea or diarrhea, blood cell count changes increasing infection risk, liver problems indicated by abnormal tests results, possible bleeding complications due to clotting issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide tumor samples or am willing to have a biopsy before starting the study.
Select...
I have had platinum-based chemotherapy or cannot have it now.
Select...
I can perform daily activities with minimal assistance.
Select...
I have previously been treated with a PD-1 or PD-L1 inhibitor.
Select...
I am 18 years old or older.
Select...
My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
My white blood cell count is healthy without needing medication.
Select...
My cancer has spread or cannot be removed by surgery.
Select...
I have previously been treated with a checkpoint inhibitor.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can provide samples of my tumor or am willing to have another biopsy.
Select...
I am not pregnant and can have children.
Select...
My cancer is a type of bladder cancer known as urothelial carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to study completion (estimated 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study completion (estimated 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Disease control rate (DCR)
Objective response rate
Overall survival
+1 moreOther outcome measures
Biomarker analysis
Frailty assessment
Maximum Plasma Concentration [Cmax]
+2 moreSide effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Activated Partial Thromboplastin Time Prolonged
15%
Sore Throat
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Generalized Muscle Weakness
8%
Allergic Rhinitis
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib, enfortumab vedotin)Experimental Treatment4 Interventions
Patients receive cabozantinib PO QD on days 1-28 and enfortumab vedotin IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,614 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,519 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,822 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation therapy in the last 2 weeks or radionuclide treatment in the last 6 weeks.I can perform daily activities with minimal assistance.I have recovered from previous treatment side effects, or they are minor and stable.I can provide tumor samples or am willing to have a biopsy before starting the study.I have previously been treated with a PD-1 or PD-L1 inhibitor.I am 18 years old or older.I haven't taken any kinase inhibitor medication in the last 2 weeks.I have had platinum-based chemotherapy or cannot have it now.My liver tests are within acceptable limits, even with bone metastases.My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.My diabetes is not under control, with an A1C level of 8% or higher.My liver function is moderately to severely impaired.My brain metastases are treated and stable for at least 4 weeks.My blood clotting tests are normal or I'm on blood thinners.I haven't had cancer treatment in the last 2 weeks.My white blood cell count is healthy without needing medication.My cancer has spread or cannot be removed by surgery.You have had an allergic reaction or hypersensitivity to the study treatment components before.I have previously been treated with a checkpoint inhibitor.I cannot swallow pills.Your disease must be measurable using specific criteria called Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).I don't have any major ongoing illnesses that would make it unsafe for me to join the study.I have a serious wound, ulcer, or bone fracture that isn't healing.I can take care of myself and am up and about more than half of my waking hours.I can provide samples of my tumor or am willing to have another biopsy.I am not pregnant and can have children.I haven't had major surgery in the last 2 weeks or minor surgery in the last 10 days.I have recovered from side effects of previous treatments.I have been treated with cabozantinib before.I am currently taking blood thinners like warfarin or aspirin.I have symptoms of underactive thyroid that aren't treated.My cancer is a type of bladder cancer known as urothelial carcinoma.I do not have any other cancer that needs treatment.I have not been in a study or treated with drugs similar to enfortumab vedotin.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cabozantinib, enfortumab vedotin)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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 there any vacancies for participants in this clinical trial?
"Confirmed. According to medical records found on clinicaltrials.gov, this trial is actively seeking participants since its inception on July 23rd 2021 and the last time it was updated was August 8th 2022. The researchers need to recruit 32 people from a single site."
Answered by AI
Has Cabozantinib S-malate been explored through previous research initiatives?
"At present, 17 of the 126 clinical trials studying Cabozantinib S-malate are in Phase 3. Most studies related to this medication take place within Cordoba and Calabria, but there is a total of 8202 sites globally running tests with it."
Answered by AI
Has the United States Food and Drug Administration given authorization to Cabozantinib S-malate?
"Due to the limited amount of data available on cabozantinib s-malate's efficacy and safety, it was assigned a score of 1."
Answered by AI
Is this the inaugural study of its kind?
"The exploration of Cabozantinib S-malate began in 2012, when a Phase 1 trial was sponsored by Exelixis. This initial research yielded positive results, leading to its subsequent regulatory approval for usage during Phase 2 trials. Currently, 126 live studies are being conducted with this drug across 1492 cities and 50 countries worldwide."
Answered by AI
How many participants may join this experiment?
"Affirmative. Data on clinicaltrials.gov confirms that this research project, initially posted on July 23rd 2021, is actively seeking participants. A total of 32 individuals will be admitted from 1 trial site."
Answered by AI
What ailments can Cabozantinib S-malate be used to ameliorate?
"Patients with high risk renal cell carcinoma may be prescribed cabozantinib s-malate in conjunction with sorafenib."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger