The purpose of this study is to is to investigate the combination of CV301 (an experimental cancer vaccine) with anti-PD-1 Therapy (atezolizumab which was approved for the treatment of advanced Urothelial Bladder Cancer) for treatment of locally advanced or metastatic UC.
CV301 involves the use of a two-component dosing regimen; a prime vaccine, MVA-BN-CV301 (the first vaccine generating a response from your immune system) and a boost vaccine, FPV-CV301 (the second vaccine increasing and maintaining the response of your immune system). Treatment with anti-PD-1 therapy may help the immune system detect and attack cancer cells.
In this clinical trial the use of CV301 vaccine in combination with atezolizumab infusion is being investigated to determine whether the overall survival and immune response observed in subjects treated with atezolizumab can be enhanced when combined with CV301.
This clinical trial is being performed at up to 8 clinical trial sites, and 68 people in total will be selected to participate. The trial is scheduled to last up to 104 weeks from the time you are first seen at the trial site until you start the long-term follow-up contacts. Once deemed eligible for participation, visits are every 3 weeks for the first 16 weeks on study. Then, visits will be every 6 weeks until week 28 on study, at which time visits will be every 12 weeks until end of treatment.
Participation in this trial will not guarantee any direct or immediate benefit, but can help gain future knowledge about the treatment of UC that may be beneficial to others with this disease.
Overactive bladder (OAB) is a clinical diagnosis characterized by the presence of bothersome urinary symptoms including urgency, frequency, nocturia, and urgency incontinence. Urinary incontinence is a prevalent condition that markedly impacts quality of life affecting both men and women. This investigation is a study of the Valencia Technologies eCoin system for people experiencing the accidental leakage of urine. If you choose to participate in this trial, you will have the eCoin device placed under the skin in your right or left leg near your ankle. The device will attempt to improve or restore normal control of your bladder by sending out electrical impulses to the tibial nerve. The electrical stimulation comes from a small device that is slightly larger than a nickel. The stimulation pulse intensity is adjusted to your highest comfortable level. An engineer will do this programming at the study center using an external controller. After activation, the implant automatically provides 30 minute stimulation sessions according to a fixed interval schedule. For the first 12 weeks of therapy, you will get your 30 minute session every third day. After 12 weeks, you will get your 30 minute sessions every fourth day. The time of day may vary from session to session. The duration of the study is 56 weeks.
The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your transitional cell cancer to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.
Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing and are expected to be very similar in safety and effectiveness. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of your cancer and allow you to live longer.
This is a randomized trial so patients will receive one of two treatments: Arm A: Gemcitabine, cisplatin, and placebo (sugar water or salt water)OR Arm B: Gemcitabine, cisplatin, and bevacizumab (an experimental drug). Arm A is the current standard treatment for patients with this type of cancer. Your participation in this trial will continue for as long the cancer is responding to or is stabilized by the drugs and you do not have any severe side effects from the drugs.
The purpose of this study is to find out what effects (good and/or bad) chemotherapy combined with external radiation therapy and possible removal of your bladder has on you and your cancer. The chemotherapy drugs used in this study (5-Fluorouracil, cisplatin, and gemcitabine) are not experimental drugs. This research is being done because we do not know whether one combination of drugs with radiation is superior to another in the treatment of your disease. This study uses similar therapies to the standard treatment, but chemotherapy and radiation therapy are given before removal of the bladder is considered. In this study, bladder removal is advised if, after chemotherapy and radiation, your tumor has not completely disappeared, if your tumor comes back, or if it gets larger.
Patients who participate in this trial will be randomized into two groups. Patients will receive either cisplatin and 5-FU chemotherapy and radiation twice per day OR gemcitabine chemotherapy and radiation once per day. Participation in this study may last up to 8 months with continued follow up after treatment is complete.