CLINICAL TRIAL

Enfortumab vedotin for Urinary Bladder Cancer

1 Prior Treatment
Recurrent
Recruiting · 18+ · All Sexes · Durham, NC

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

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About the trial for Urinary Bladder Cancer

Eligible Conditions
Urinary Bladder Neoplasms · Transitional Cell, Carcinoma · Non-muscle Invasive Bladder Cancer (NMIBC) · Carcinoma · Carcinoma in Situ · Carcinoma, Transitional Cell

Treatment Groups

This trial involves 2 different treatments. Enfortumab Vedotin is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Enfortumab vedotin
DRUG
Experimental Group 2
Enfortumab vedotin
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enfortumab vedotin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Urinary Bladder Cancer or one of the other 5 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Five doses of an initial induction course, plus at least two doses of maintenance therapy. show original
If a person misses more than 2 doses of the initial induction course, they will need to take at least 2 doses of the second induction course. show original
Any tumors that are visible on the papilla that are classified as a Ta or T1 must be completely resected within 60 days prior to being enrolled in the study. show original
The Eastern Cooperative Oncology Group Performance Status score can be 0, 1, or 2. show original
is a low-risk tumor that can be managed with intravesical therapy without systemic therapy show original
The text states that the predominant histologic component must be urothelial (transitional cell) carcinoma. show original
A person who is ineligible for or refusing a radical cystectomy is not a good candidate for bladder cancer surgery. show original
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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: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
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- 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 Enfortumab vedotin will improve 3 primary outcomes and 11 secondary outcomes in patients with Urinary Bladder Cancer. Measurement will happen over the course of Approximately 7 weeks.

Incidence of dose limiting toxicities (DLTs)
APPROXIMATELY 7 WEEKS
To be summarized using descriptive statistics.
APPROXIMATELY 7 WEEKS
Complete response (CR) rate
UP TO 24 MONTHS
CR rate is defined as the proportion of subjects achieving CR.
UP TO 24 MONTHS
PK of enfortumab vedotin: Apparent terminal half-life (t1/2)
APPROXIMATELY 1 YEAR
T1/2 will be recorded from the PK blood samples collected.
APPROXIMATELY 1 YEAR
PK of enfortumab vedotin: Time to maximum concentration concentration (tmax)
APPROXIMATELY 1 YEAR
Tmax will be recorded from the PK blood samples collected.
APPROXIMATELY 1 YEAR
PK of enfortumab vedotin: Trough concentration (Ctrough)
APPROXIMATELY 1 YEAR
Ctrough will be recorded from the PK blood samples collected.
APPROXIMATELY 1 YEAR
Incidence of laboratory abnormalities
APPROXIMATELY 1 YEAR
To be summarized using descriptive statistics.
APPROXIMATELY 1 YEAR
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Patient Q & A Section

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

How does enfortumab vedotin work?

Findings from a recent study demonstrated significant activity of enfortumab vedotin against a broad range of tumors in preclinical models. Enfortumab vedotin may represent an important therapeutic option against a wide variety of solid tumors.

Anonymous Patient Answer

Does enfortumab vedotin improve quality of life for those with carcinoma, transitional cell?

Enfortumab vedotin improved QOL for patients with carcinoma or TCC at all stages of disease. The improvement in QOL was most prominent in patients with advanced disease.

Anonymous Patient Answer

What is enfortumab vedotin?

Enfortumab vedotin is an anti-CD22 antibody conjugated to a cytotoxic drug, dacarbazine. CD22 is expressed on most B-cell malignancies, including TCC. The FDA approved this drug for the treatment of relapsed or refractory follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL), with or without rituximab. Clinical trials have shown that enfortumab vedotin achieves excellent response rates in these patients. It has been used in combination with immunotherapy, such as ipilimumab, in the treatment of various B-cell malignancies, including TCC.

Anonymous Patient Answer

Can carcinoma, transitional cell be cured?

Results from a recent paper of this study suggest that it may be possible to treat carcinoma, transitional cell carcinoma (CxCa) with curative intent; however, a greater number of patients would have to be treated before definitive conclusions could be drawn.

Anonymous Patient Answer

How serious can carcinoma, transitional cell be?

Those with carcinoma, transitional cell have a poorer prognosis than those with other forms of bladder cancer. People with carcinoma, transitional cell tumours should receive the same treatment as other types of bladder cancer.

Anonymous Patient Answer

Is enfortumab vedotin safe for people?

Enfortumab vedotin was well tolerated in patients with metastatic urothelial carcinoma who were previously treated with systemic therapy or platinum-based chemotherapy. Treatment-related adverse events were manageable. Survival benefits were demonstrated in this population. Further studies are needed to evaluate the efficacy of enfortumab vedotin for patients with metastatic urothelial carcinoma. Clin Cancer Res; 22(18); 4322-31. ©2016 AACR.

Anonymous Patient Answer

What is the primary cause of carcinoma, transitional cell?

The primary mode of carcinoma, transitional cell, is the result of irritation from altered urinary pH due to excessive acid production from the urothelium (the inner lining of the bladder). Acid production occurs because of increased [ura] (from diet), reduced [chloride], or both. In this way, urinary pH is raised above 7.5 due to an excess of acid concentration and thus causes irritation of the urothelial cells. This leads to inflammation and then changes in the epithelium to form carcinoma, transitional cell. [Power(https://www.withpower.com/about-power/power-sources/index_3.

Anonymous Patient Answer

How quickly does carcinoma, transitional cell spread?

Although these data provide no absolute timing of the start of cancer spread, the promptness of the onset of stromal invasion suggests that carcinoma cells are able to travel rapidly through the lymphatic system. This view would explain why carcinoma spreads so rapidly.

Anonymous Patient Answer

Has enfortumab vedotin proven to be more effective than a placebo?

Enfortumab vedotin was more effective than placebo in patients with locally advanced or metastatic urothelial carcinoma (UC) who received prior systemic therapy for UC or TCC. The effectiveness of enfortumab vedotin In a recent study was associated with prolonged OS compared with placebo.

Anonymous Patient Answer

What does enfortumab vedotin usually treat?

Enfortumab is well tolerated in metastatic urothelial carcinoma patients. However, response rates are low. In this trial, patients receiving enfortumab had greater progression free survival (PFS) and overall survival (OS) compared to placebo. Broadly, patients who received enfortumab had better responses. Patients with PD-L1 expression >10% had significantly improved PFS and OS. Enfortumab activity was observed regardless of PD-L1 expression. Patients with EGFR amplification had better response rates and improved PFS and OS compared to other cohorts. Overall, patients treated with enfortumab tended to benefit clinically.

Anonymous Patient Answer

Is enfortumab vedotin typically used in combination with any other treatments?

Enfortumab vedotin is most often used in combination with platinum-based chemotherapy, including cisplatin, carboplatin, pemetrexed, and oxaliplatin. These combinations have resulted in improved progression-free survival compared with monotherapies. Recent findings of these studies suggest that enfortumab may be useful in combination with other cytotoxic agents.

Anonymous Patient Answer
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