← Back to Search

Tyrosine Kinase Inhibitor

Immunotherapy + Targeted Therapy for Genitourinary Cancers

Phase 2
Recruiting
Led By Andrea B Apolo
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of specified metastatic cohorts
No evidence of tumor invading major blood vessels, GI tract, or any other specified conditions
Must not have
History of organ or allogeneic stem cell transplant
Active autoimmune disease or history of autoimmune disease that might recur
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is studying a combination of drugs as a possible treatment for rare genitourinary tumors.

Who is the study for?
This trial is for adults with rare genitourinary tumors that have spread, who can swallow pills and don't have active brain metastases or certain illnesses. They may have had up to two cancer treatments before or none at all. Participants must not be on warfarin, have a good performance status (Karnofsky >=80%), no recent major surgeries, no severe allergies to monoclonal antibodies, and controlled medical conditions are okay.
What is being tested?
The study tests how well the combination of cabozantinib (a drug blocking enzymes needed for cell growth), nivolumab and ipilimumab (both immunotherapy drugs) works against advanced genitourinary cancers compared to each drug alone. It's a phase II trial where these drugs' effectiveness in stopping tumor growth will be observed using scans like PET, CT, MRI.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in organs due to nivolumab and ipilimumab; fatigue; digestive issues; skin problems; hormonal changes; increased risk of infections. Cabozantinib might cause high blood pressure, hand-foot syndrome (redness and pain in hands/feet), mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer's type and stage have been confirmed with a biopsy.
Select...
My cancer has not spread to major blood vessels or the digestive system.
Select...
I do not have any active cancer spread to my brain.
Select...
I am 18 years old or older.
Select...
I am not taking warfarin or certain long-term medications.
Select...
I am mostly self-sufficient and active.
Select...
I do not have an active autoimmune disease or a history of one that might come back.
Select...
My cancer has spread to new areas or worsened, as shown on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had an organ or stem cell transplant.
Select...
I have or had an autoimmune disease that could come back.

Timeline

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

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Clinical benefit rate (CBR)
Duration of response
Incidence of adverse events (AE)
+2 more
Other study objectives
Effects of treatment in patients with bone-only disease

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02315430
85%
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%
Sore Throat
15%
Activated Partial Thromboplastin Time Prolonged
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, nivolumab, ipilimumab)Experimental Treatment7 Interventions
Patients receive cabozantinib PO QD on days 1-21 of cycles 1-4 and on days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Treatment repeats every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, and bone scan throughout the trial and may undergo PET/CT throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3140
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Nivolumab
2014
Completed Phase 3
~5220
Positron Emission Tomography
2011
Completed Phase 2
~2200
Bone Scan
2015
Completed Phase 2
~50
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2740

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,686 Total Patients Enrolled
Andrea B ApoloPrincipal InvestigatorAlliance for Clinical Trials in Oncology
3 Previous Clinical Trials
1,041 Total Patients Enrolled

Media Library

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03866382 — Phase 2
Bladder Cancer Research Study Groups: Treatment (cabozantinib, nivolumab, ipilimumab)
Bladder Cancer Clinical Trial 2023: Cabozantinib S-malate Highlights & Side Effects. Trial Name: NCT03866382 — Phase 2
Cabozantinib S-malate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03866382 — Phase 2
~23 spots leftby Feb 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.
Back to top