Mark D. Tyson, II, M.D., M.P.H.

This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC.

This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is.

The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: -Participants with CIS (± Ta/T1) who are BCG naive, or -Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: -Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.

The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are unfit for radical cystectomy (RC) during an 84-day induction period comprised of four consecutive 21-day dosing cycles.

The purpose of this study is to investigate the effectiveness and safety of UroGen's UGN-102 to treat patients with Low Grade (LG) Non Muscle Invasive Bladder Cancer (NMIBC) at intermediate risk of recurrence.

The purpose of this study is to evaluate the activity of intravesical (IVE) administration of Cretostimogene Grenadenorepvec in patients with tissue pathology confirmed non-muscule invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease.

The purpose of this study is to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction or that is naïve to BCG treatment.

The purpose of this study is to assess the safety and tolerability of durvalumab (1500 mg iv for 13 cycles every four weeks (q4w) + BCG (induction and maintenance) combination therapy by assessment of Grade 3/4 PRAEs in high-risk NMIBC participants.

The purpose of this study is to evaluate patient-reported preference for CxBladder Monitor compared to cystoscopy for patients on surveillance for NMIBC.

For Cohort A, the purpose of this study is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with CIS disease (with or without Ta/T1) in terms of complete response (CR) rate using cystoscopy, confirmatory bladder biopsy, and urine cytology. For Cohort B, the purpose is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with high-grade papillary disease (Ta/T1 only) in terms of disease-free survival (DFS) using cystoscopy, confirmatory bladder biopsy, and urine cytology.

The purpose of this study is to test drug enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.

The purpose of this study is to collect data on the early use of ADSTILADRIN. Data will be collected from participants, caregivers and prescribing physicians in a real-world setting.

The purpose of this egistry study is to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care.

The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

The purpose of this study is to compare general and disease-specific quality of life outcomes at 6, 12, 24, and 36 months after treatment for localized bladder cancer using the PROMIS-29 and the Bladder Cancer Index (BCI) respectively and to identify patient level characteristics that may influence quality of life outcomes after treatment for localized bladder cancer.

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

The primary purpose of this study is to characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.