CLINICAL TRIAL

Cabozantinib for Urinary Bladder Cancer

Recruiting · 18+ · All Sexes · Milwaukee, WI

This study is evaluating whether a combination of two drugs may help treat muscle invasive bladder cancer.

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About the trial for Urinary Bladder Cancer

Eligible Conditions
Urinary Bladder Neoplasms · Bladder Cancer, Cancer

Treatment Groups

This trial involves 2 different treatments. Cabozantinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cabozantinib
DRUG
Atezolizumab
DRUG
Cystectomy
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Atezolizumab
FDA approved
Cystectomy
2014
Completed Phase 2
~120

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Urothelial carcinoma should be the predominant component (≥ 50%). NOTE: Any neuroendocrine differentiation is not permitted.
Creatinine clearance < 60 mL/min (Cockcroft-Gault formula will be used to calculate creatinine clearance)
Age ≥18 years at the time of consent.
ECOG Performance Status of ≤ 2 within 28 days prior to registration.
Archival tissue is required, if available. The tissue should be identified at screening and shipped after registration, prior to Cycle 3 Day 1. If archival tissue is not available a repeat biopsy is not required, and the subject may still be eligible. Archival tissue should have been obtained within 60 days prior to registration.
Clinical stage T2-T4aN0/xM0 disease.
Medically appropriate candidate for radical cystectomy as assessed by surgeon.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cabozantinib will improve 1 primary outcome and 3 secondary outcomes in patients with Urinary Bladder Cancer. Measurement will happen over the course of 12 months.

Event Free Survival
12 MONTHS
EFS is defined as the time from registration to the first recurrence of disease after cystectomy, the time of first documented progression in patients who are precluded from cystectomy, or the time of death due to any cause, whichever occurs first.
Pathologic complete response rate
12 MONTHS
Estimate the pathologic complete response (pCR) rate to neoadjuvant cabozantinib and atezolizumab in subjects with muscle-invasive urothelial cancer of the bladder. pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per local institutional pathology review using specimens obtained via cystectomy following the neoadjuvant treatment.
Frequency and Severity of Adverse Events
12 MONTHS
Assess the frequency and severity of adverse events per CTCAE v5
Pathologic Response Rate
12 MONTHS
Estimate the pathologic response (PaR) rate to neoadjuvant cabozantinib and atezolizumab in subjects with muscle-invasive urothelial cancer of the bladder. Pathologic response rate (PaR) is defined as the absence of residual muscle-invasive cancer in the surgical specimen (pathologic downstaging to ≤ pT1pN0), which includes pT0, pT1, pTa, and pTis

Patient Q & A Section

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

What are the signs of urinary bladder cancer?

The signs of urinary bladder cancer are rare, and can be diagnosed only incidentally by history or physical examination. The most important sign of bladder cancer is the presence of a palpable mass or mass detected during imaging studies.

Anonymous Patient Answer

Can urinary bladder cancer be cured?

The incidence and mortality of transitional cell adenocarcinoma remains high throughout the world and the disease is far from curable. The only treatments are palliative care during the disease course and the eventual control of life-threatening complications. The authors' view is that patients with urinary bladder cancer, who have a good prognosis, should be offered the full best of medical treatment and all treatments should be provided on an equal basis as possible. These will minimize treatment heterogeneity and lead to a better treatment result.

Anonymous Patient Answer

What is urinary bladder cancer?

The global incidence of bladder cancer continues to climb during most of the last 20 years. Although the incidence is higher in developed countries, the number of new cases of bladder cancer in developing countries is increasing. Most bladder cancer patients are diagnosed after their disease has begun. Bladder cancer is not a transmissible disease because it is not contagious, although it spreads through the air, through water, and into the soil. The disease is not related to environmental exposures to environmental carcinogens (dioxin, polycyclic aromatic hydrocarbons (e.g., benzo["a"]pyrene), or cigarette smoke) but probably arises as a result of alterations in epithelial cell physiology and/or DNA repair pathways.

Anonymous Patient Answer

What causes urinary bladder cancer?

A genetic predisposition may have a role. Other plausible factors are tobacco smoking and occupation. Smoking is the most prevalent cause of [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) incidence, whereas bladder cancer related to bladder cancer in the first degree relatives is less common. It is possible that this cancer has a multifactorial etiology.

Anonymous Patient Answer

How many people get urinary bladder cancer a year in the United States?

Nearly a quarter of the patients with bladder cancer in America are black. The disease and mortality from urinary bladder cancer in this population are much higher than in white patients, who make up the majority of the U.S. population.

Anonymous Patient Answer

What are common treatments for urinary bladder cancer?

While most patients in current trials will receive neoadjuvant treatment, some trials use a combination of treatment modalities, and a small percentage of patients will receive adjuvant treatment. In addition to neoadjuvant therapy with the treatment of choice, which includes chemotherapy, radiation, and/or surgery, some trials are investigating intravesical therapy. Intravesical therapy typically consist of a single dose of the immunotherapy drug interferon-alpha, which can cause patients to experience a slight improvement in symptoms, improvement in quality of life, and/or complete disappearance of symptoms. However, in some trials, patients with small tumors, who are unlikely to receive chemotherapy, are still experiencing disease progression-free survival improvements.

Anonymous Patient Answer

What is the survival rate for urinary bladder cancer?

The 5 year survival rate for urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) is 67% at St. Vincent Hospital in Southfield, MI. The 5 year survival rate for low grade tumors is 81%. For high grade tumors, which includes transitional cell carcinoma, the 5 year survival rate is only 56%. In total, the 5 year survival rate is 66.7%. Patients whose cancer has not invaded the surrounding muscle or the bladder neck are classified as transitional cell carcinoma in situ. It is imperative that patients with transitional cell carcinoma in situ and patients with transitional cell carcinoma who are medically fit be checked repeatedly to be sure that they are not developing invasive cancer. Survival rates for the invasive stage of transitional cell carcinoma can be found at http://www.

Anonymous Patient Answer

What does cabozantinib usually treat?

Cabozantinib is an effective, tolerable, and well-tolerated new targeted drug for treatment of metastatic urothelial carcinoma. This drug can also be the second line treatment for platinum-refractory disease not responding to [bevacizumab] in patients with newly diagnosed [pancreatic ductal adenocarcinoma], who have previously received platinum-based regimen.

Anonymous Patient Answer

What is the latest research for urinary bladder cancer?

An experiment using human urinary bladder carcinoma cells showed that a group of synthetic oligosaccharides (PS, PSH, LPSH) which have been shown to induce apoptosis of human leukemia HL60 or U937 cells in vitro had antimetastatic activity against the human urinary bladder carcinoma cell line (T24), suppressing the metastasizing ability of this cell line, which in turn, resulted in a decrease in the incidence of lung metastases. This suggests that PS, PSH and LPSH may be used as antimetastatic drugs for urinary bladder carcinoma.

Anonymous Patient Answer

What are the chances of developing urinary bladder cancer?

The predicted probability of bladder cancer occurrence at age 65 years was found to be 2% in males and 1% in females. When the probability equals 1%, the probability of bladder cancer occurs at age 64 years in males and at age 62 years in females. The expected number of bladder cancer cases per year in a specific age group is approximately 6% in males and 4% in females. It is of importance to note that the probability increases with age: 0.6% in men and 0.3% in women aged 45 years. Amongst men, the probability is 1.2% at age 65 years. For women, the risk increases with age: 0.6% at age 65 years.

Anonymous Patient Answer

What are the latest developments in cabozantinib for therapeutic use?

cabozantinib has been the subject of extensive drug development activities, resulting in three oral compounds with a unique pharmacokinetic profile from Phase II to Phase III clinical trials. The current clinical role of cabozantinib is to advance the therapeutic use of targeted therapy for cancer patients intolerant of conventional therapies.

Anonymous Patient Answer

How does cabozantinib work?

Cabozantinib has unique molecular properties. In preclinical studies, cabozantinib reduced cellular growth in a variety of human tumor lines. Importantly, in patients with metastatic bladder cancer with or without a BRAF V600E mutation, cabozantinib resulted in a significantly improved clinical benefit. Cabozantinib is now being tested in a phase 1/2 multicenter clinical trial in patients with bladder cancer with or without a BRAF V600E mutation.

Anonymous Patient Answer
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