Enfortumab vedotin for Urinary Bladder Cancer
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
See full descriptionAbout the trial for Urinary Bladder Cancer
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.
About The Treatment
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.