Timothy D. Lyon, M.D.

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 primary objective of this study is to characterize the safety and toxicity profile of TARA-002 administered intravesically.

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.

This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.

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 evaluate patient-reported preference for CxBladder Monitor compared to cystoscopy for patients on surveillance for NMIBC.

The purpose of this study is to evaluate how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.

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

The primary purpose of this study is to assess the effectiveness of a single intraoperative intravesical instillation of gemcitabine at time of radical nephroureterectomy (RNU) to prevent intravesical recurrence of urothelial carcinoma (UC) at 1 year in patients with clinically localized upper tract urothelial carcinoma (UTUC).

The purposes of this study are to assess image quality of a multiparametric MRI protocol for local staging imaging among patients with bladder cancer, and to assess accuracy of MR imaging in determining muscle invasion.

The purpose of this study is to explore thoughts and experiences of bladder cancer patients who underwent radical cystectomy at Mayo Clinic Florida through qualitative interviews.

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.