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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 uncontrolled, significant intercurrent or recent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My cancer's type and stage have been confirmed with a biopsy.
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I do not have any severe illnesses that are not under control.
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My cancer has not spread to major blood vessels or the digestive system.
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I haven't had any major surgeries recently.
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I do not have any active cancer spread to my brain.
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I am 18 years old or older.
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I have had no more than 2 cancer treatments or none at all.
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I can swallow pills.
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I manage my condition with creams or hormone replacements.
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I have recovered from side effects of my previous treatments.
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I am not taking warfarin or certain long-term medications.
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I haven't had any major medical events or treatments recently.
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I am mostly self-sufficient and active.
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I do not have an active autoimmune disease or a history of one that might come back.
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My cancer has spread to new areas or worsened, as shown on scans.
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I haven't needed treatment for any cancer besides my current one in the last 2 years.
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I have taken a pregnancy test within the last week and it was negative.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response
Incidence of adverse events (AE)
+2 more
Other outcome measures
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, nivolumab IV and ipilimumab IV while on study. Patients undergo CT scan, MRI, PET and bone scans throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Positron Emission Tomography
2008
Completed Phase 2
~2260
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2790
Ipilimumab
2014
Completed Phase 3
~2670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,167 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any North American medical centers that have initiated this research?

"Epic Care Partners in Cancer Care, located in Emeryville, California; Saint Francis Medical Center situated in Cape Girardeau, Missouri; and the Missouri Baptist Outpatient Centre-Sunset Hills based out of Sunset Hills, Michigan are among the 100 other trial sites currently recruiting patients."

Answered by AI

Has the regulatory body given its blessing to Cabozantinib S-malate?

"Cabozantinib S-malate's safety is rated at 2 due to the Phase 2 trial, which has evidence of its security but no proof of efficacy."

Answered by AI

What illnesses has Cabozantinib S-malate been found to be efficacious in alleviating?

"Cabozantinib S-malate is a common remedy for unresectable melanoma, but has also been used to treat squamous cell carcinoma, high recurrence risk cases, and other illnesses."

Answered by AI

How many participants are taking part in the research trial?

"Affirmative, per the clinicaltrials.gov portal this medical study is currently recruiting individuals for participation. The trial was initially posted on April 12th 2019 and recently updated on November 24th 2022. This research requires 224 participants from 100 sites to be recruited."

Answered by AI

Is the recruitment process for this trial still open?

"Yes, according to clinicaltrials.gov this research project is currently seeking participants. It was initially advertised on April 12th 2019 and the most recent edit happened on November 24th 2022. A total of 224 volunteers are needed from 100 different sites."

Answered by AI

Are there any past experiments that utilized Cabozantinib S-malate?

"At present, there is a total of 841 clinical trials being conducted for Cabozantinib S-malate with 94 taking place in the third phase. Although Pittsburgh, Pennsylvania hosts many of these studies, 46024 sites are currently evaluating this medication."

Answered by AI
~36 spots leftby Feb 2025