Bladder Cancer Trials

This is a phase 3, open label, single arm study of TOOKAD (padeliporfin, a type of targeted therapy) in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade upper tract urothelial carcinoma in either the kidney or the ureter. The patients will be treated with TOOKAD VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for additional 12 months in the long term (non-intervention) follow up phase. The study has 1 treatment arm: Patients entered in the study will undergo an induction treatment phase consisting of 1-3 TOOKAD VTP treatments provided 4 weeks (28 +/-3 days) apart. Patients achieving a complete response (CR, no further evidence of your cancer) after the induction treatment phase will be allowed into the maintenance treatment phase. Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable. During treatment, an optical light fiber will be placed at a determined target area, through a ureteroscope. Intravenous (IV) administration of TOOKAD at the dose of 3.66 mg/kg will be infused over 10 minutes. Each target area will be illuminated for 10 minutes.

This is a Phase 3, open-label, randomized trial designed to evaluate the recurrence free survival of TURBT followed by cretostimogene Grenadenorepvec (a type of targeted immunotherapy) versus TURBT followed by observation for the treatment of participants with IR-NMIBC. Participants who recur after TURBT and observation will be offered treatment with cretostimogene. This study has 2 arms: Arm A: Cretostimogene after TURBT Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene. Dosing and schedule will be provided by the treatment team. Arm B: Observation after TURBT Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter observation. Participants who recur after TURBT and observation will be offered treatment with cretostimogene.

Small cell carcinoma of the bladder (SCCB) and other high-grade neuroendocrine tumors (HGNET) of the urinary tract are rare but aggressive cancers. Average survival for people diagnosed with SCCB or HGNET is about 1 year. Lurbinectedin (Zepzelca, a type of chemotherapy) and avelumab (Bavencio, a type of immunotherapy) are drugs that are approved to treat other cancers. Researchers want to see if these drugs can help people with SCCB or HGNET. The objective of this study is to assess the objective response rate (ORR, how many patients have their cancer shrink in response to taking the study medication) of lurbinectedin, either alone or in combination with avelumab, in participants with small cell carcinoma of the bladder (SCCB) or other high grade neuroendocrine tumors (HGNETs) of the urinary tract. This study has 2 treatment arms: Arm A: Lurbinectedin Lurbinectedin is administered intravenously (IV) over 1 hour on day 1 of each 21-day cycle. Arm B: Lurbinectedin + Avelumab Lurbinectedin is administered intravenously (IV) over 1 hour on day 1 of each 21-day cycle PLUS Avelumab is administered IV at 800 mg over 1 hour on day 1 of each 21-day cycle.

Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors. The objective of this study is to learn more about urinary tract cancers. Rare histological variants of the GU tract include bladder/urachal adenocarcinoma, squamous cell carcinoma, and small cell carcinoma; variants of urothelial carcinoma including plasmacytoid, sarcomatoid; renal tumors including sarcomatoid renal cell carcinoma and renal medullary carcinoma; penile cancers; micropapillary, giant cell, lipid rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns; small cell neuroendocrine carcinoma of the prostate, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC. Some GU tumors occur so infrequently that they are not systematically captured by currently available registries, treatment protocols or tissue banks. The rarity of these tumors limits the sufficient numbers of patients needed in larger randomized clinical studies to characterize standard treatments or disease course. Systematic and longitudinal collection and annotation of clinical history, tissue samples, imaging studies, participant reported outcomes, and other pertinent information in participants with these rare tumors will yield future knowledge and help with the development of subsequent prospective studies to optimize diagnosis and treatment paradigms for less common GU tumors. There is no treatment given as part of this study. This will be a long-term study to comprehensively study participants with rare GU tumors. Medical history will be collected, and participants followed throughout the course of their illnesses, with particular attention to patterns of disease presentation, recurrence and progression, response to therapies, duration of responses and participant reported outcomes. Tissue samples and blood will be obtained from participants during this study. A broad spectrum of scientific experiments, including genomics and immune monitoring will be performed.

This phase II trial studies how well cabozantinib (Cabometyx, a type of targeted therapy) works in combination with nivolumab (Opdivo, a type of immunotherapy) and ipilimumab (Yervoy, a type of immunotherapy) in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone. All participants will receive treatment: Treatment (cabozantinib, nivolumab, ipilimumab) Patients will take cabozantinib orally (PO) QD on days 1-21 of cycles 1-4, and on days 1-28 of subsequent cycles. Patients also receive nivolumab intravenously (IV) over 30 minutes on day 1 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Treatment repeats every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years.

This phase III trial compares the effectiveness of pembrolizumab (Keytruda, a type of immunotherapy) and sacituzumab govitecan (a type of targeted chemotherapy) to standard of care in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Immunotherapy may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Standard of care is treatment with chemotherapy such as cisplatin, carboplatin, gemcitabine, docetaxel or paclitaxel. Giving pembrolizumab and sacituzumab govitecan may be more effective than standard of care with carboplatin or cisplatin with gemcitabine, docetaxel or paclitaxel in treating patients with locally advanced or metastatic urothelial cancer. This study has 2 treatment arms: Arm A: Standard of care Chemotherapy will be given intravenously (IV). Medications, dosage and dosing schedule will be provided by treatment team. Arm B: Pembrolizumab + sacituzumab govitecan Patients receive pembrolizumab IV over 30 minutes on day 1 and sacituzumab govitecan IV over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, but require an additional treatment called immunotherapy to help prevent their bladder cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab (Opdivo) and relatlimab, can help the body's immune system to attack cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life, and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of bladder cancer patients who have undergone surgical removal of their bladder. This study has 3 arms: Arm A: Nivolumab Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial. Arm B: Nivolumab + Relatlimab Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial. Arm C: ctDNA surveillance + nivolumab Patients undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans throughout the trial.

Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab (a type of targeted therapy) in combination with budigalimab (a type of immunotherapy). This study has 2 arms: Arm A: Livmoniplimab + Budigalimab Participants will receive livmoniplimab intravenously (IV) in combination with budigalimab IV, as part of the approximately 3.5 years study duration. Dosage and dosing schedule will be provided by treating site. Arm B: Standard of care with Docetaxel, Paclitaxel, or Gemcitabine (these are all types of chemotherapy) Participants will receive investigator's choice of docetaxel, paclitaxel, or gemcitabine, all given IV, as part of the approximately 3.5 years study duration.

This is an open-label, expanded access trial designed to provide access to cretostimogene (a type of immunotherapy) in patients with NMIBC unresponsive to BCG (another type of immunotherapy). All participants will receive treatment, and will be assigned the same treatment schedule. Participants will receive an induction course of 6 weekly treatments, and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15.

This study is being done to learn more about a new medicine called PF-08634404 (a type of targeted immunotherapy). It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body. The purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects cancer. The study will also look at how this medicine may change certain markers in the body that are linked to cancer. This study has 2 treatment arms: Arm A: PF-08634404 alone PF-08634404 is given intravenously (IV) Arm B: PF-08634404 + enfortumab vedotin Enfortumab vedotin (Padcev, a type of targeted therapy) is also given IV. Dosages and dosing schedules will be provided by the treatment site.

Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy. Researchers want to know if giving sacituzumab tirumotecan (sac-TMT, a type of targeted therapy) can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies. This study has 2 treatment arms: Arm A: Sacituzumab tirumotecan Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity. Arm B: Chemotherapy Participants receive paclitaxel 175 mg/m2, docetaxel 75 mg/m2, or vinflunine 320 mg/m2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity.

This phase II trial tests the effect of giving pembrolizumab (Keytruda, a type of immunotherapy) 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 to 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. This study has 1 treatment arm: photon beam radiation therapy (RT) + pembrolizumab Patients undergo photon beam RT once daily on Monday-Friday for up to 20 treatments and receive pembrolizumab IV (intravenously) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 18 cycles (for a total of 12 months) in the absence of disease progression or unacceptable toxicity.

This is a registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices. The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by Global Vision Technologies. Data will be captured longitudinally over five (5) years on patients from each enrolled site. Each center will enter their respective site's patient data electronically. This study does NOT offer any treatment.

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan (a type of targeted therapy) and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works. All subjects will receive treatment. The study has 1 treatment arm: Sacituzumab tirumotecan Participants receive intravesical (instilled directly into the bladder) Sacituzumab Tirumotecan for 6 weeks at varying dose levels. Treatment dose and dosing scheduled will be provided by the study team.

The main objectives of this study are to determine the feasibility and safety of AU-011 (a type of immunotherapy) treatment of bladder cancer utilizing intratumoral (directly in the tumor) injection with or without intramural (injection to the local tumor area) injection and with or without laser application. This study has 6 treatment arms: Arm A: Intratumoral and intramural injection of AU-011 prior to TURBT Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC. Arm B: Intratumoral and intramural injection of AU-011 with laser application before TURBT Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC. Arm C: Intratumoral injection of AU-011 with laser application before TURBT Intratumoral injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC. Arm D: Intratumoral injection of AU-011 with laser application before TURBT Intratumoral injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC. Arm E: AU-011 intratumoral injection with laser application prior to cystectomy Intratumoral injection of AU-011 (100 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC. Arm F: AU-011 intratumoral injection with laser application prior to cystectomy Intratumoral injection of AU-011 (200 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC. Treatment dose and treatment schedule will be provided by the study team.

Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin (a type of gene therapy) in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting. There is no treatment provided as part of this study.

"This study will evaluate the safety and effectiveness of intravesical (directly into the bladder) administration of EG-70 in the bladder and its effect on bladder tumors in patients with non-muscle invasive bladder cancer (NMIBC). The study will include patients with NMIBC for whom BCG therapy is unresponsive and are recommended for radical cystectomy, or high-risk NMIBC patients who are BCG-naïve or have received incomplete BCG treatment. EG-70 is a novel non-viral gene therapy. EG-70 is designed to elicit a local immune response following delivery of the study gene therapy to the bladder urothelium (cells lining the bladder). This approach of local administration through bladder instillation has the potential to induce a potent immune response exclusively at the site of the tumor, resulting in greater therapeutic benefit while reducing undesirable systemic toxicity. All subjects will receive treatment will EG-70. Dose level will be provided by the treatment site. Patients will receive up to 4 cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle lasts approximately 12 weeks. "

A Phase 2/3 Trial of Izalontamab Brengitecan (a type of targeted therapy) versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy. This study has 2 treatment arms: Arm A: Izalontamab Brengitecan Dosage and dosing schedule will be provided by treatment team. Arm B: Platinum based chemotherapy (Cisplatin, Gemcitabine, Carboplatin) Dosing regimen, dosage and dosing schedule will be provided by treatment team.

The purpose of this study is to test a new medicine, vepugratinib (a type of targeted therapy), in comparison with placebo, to see if it is safe and can help people with bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin (Padcev, a type of targeted therapy) and pembrolizumab (Keytruda, a type of immunotherapy). This study has 2 treatment arms: Arm A: Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion. Dosage and dosing schedule will be provided by the treatment team. Arm B: Placebo + EV + Pembrolizumab Placebo administered orally, and EV + pembrolizumab administered by IV infusion. Dosage and dosing schedule will be provided by the treatment team.

This is a phase III, single-arm, multicenter, international study to assess the effectiveness and safety of ONCOFID-P-B (a type of chemotherapy) following intravesical instillation (infused directly into the bladder) in adult patients with histologically and cytologically confirmed carcinoma in situ (CIS) of the bladder, with or without papillary disease, who are unresponsive to Bacillus Calmette–Guérin (BCG) therapy and unwilling or unfit to undergo radical cystectomy. All subjects will receive treatment. ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) ONCOFID P-B will be infused directly into the bladder (intravesically) once a week for 12 consecutive weeks (induction phase). Patients who achieve a complete response (meaning the cancer can no longer be seen on imaging) at the end of the induction phase will enter the maintenance phase, during which ONCOFID-P-B is administered once a month for 12 months until recurrence or progression of the disease.

This is a Phase I/Phase II study. Phase 1 will be conducted in BCG-unresponsive (a type of chemotherapy given directly in the bladder) patients with non-metastatic invasive bladder cancer (NMIBC) to establish the safety of durvalumab (Imfinzi, a type of immunotherapy) given:

1. alone

2. in combination with BCG

3. in combination with external beam radiation therapy (EBRT)



Provided safety is demonstrated, the study will proceed to phase 2 testing. Phase 2 will be conducted in the BCG-relapsing (meaning the cancer returns after treatment with BCG) NMIBC population. In phase 2, BCG-relapsing NMIBC subjects will be randomized to treatment with:

1. intravesical (directly in the bladder) BCG in combination with durvalumab

2. durvalumab in combination with radiation (EBRT)

3. retreatment with intravesical BCG alone



In addition to providing additional safety data on the combination regimens studied, phase 2 will provide preliminary information on effectiveness for BCG-relapsing NMIBC subjects.

Durvalumab is given intravenously (IV) in clinic. BCG is instilled (infused) directly in to the bladder in clinic. Frequency of visit dates will vary depending on which treatment arm you are assigned to.

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 (a type of targeted therapy). LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse. This study has 2 potential treatment arms: Arm A: LOXO-435 alone LOXO-435 will be administered orally (by mouth, PO) at various dosages. Dosage will be provided by the treatment team. Arm B: LOXO-435 + Pembrolizumab (Keytruda, a type of immunotherapy) LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV). Dosage and dosing schedule will be provided by the treatment team.

This trial will evaluate the use of combination pembrolizumab (Keytruda, a type of immunotherapy) and enfortumab vedotin (PADCEV, a type of targeted therapy) for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients' intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset. This study has 1 treatment arm: Pembrolizumab + Enfortumab Vedotin Enfortumab vedotin will be administered on Days 1 and 8 of every 21 day cycle, at 1.25mg/kg by intravenous (IV) infusion given over approximately 30 minutes. Pembrolizumab will be administered on Day 1 of every 21 day cycle at 200mg by IV infusion over approximately 30 minutes. Enfortumab vedotin and Pembrolizumab may be administered for up to total of 35 cycles (approximately 2 years).

This phase II trial compares the use of pembrolizumab (Keytruda, a type of immunotherapy) and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer. This study has 2 treatment arms: Arm A: Chemotherapy and radiation Patients receive one of the following chemotherapy regimens per physician's choice: 1. cisplatin intravenously (IV) once per week for 4 weeks, 2. gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22, and 25, or 3. mitomycin IV on day 1 and 5-fluorouracil IV continuously over 120 hours on days 1-5 and 16-20. Patients receiving cisplatin or gemcitabine continue chemotherapy for 6 weeks if they are receiving radiation according to the standard hypo fractionated radiation schedule. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Arm B: Pembrolizumab and radiation Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity.

This research is being done to learn more about coping and survivorship of women with bladder cancer, specifically regarding psychosocial distress and sexual dysfunction. This study is a non-therapeutic study and will randomize participants to a standard of care group and an education group. Patients in both groups will be asked to complete surveys regarding their mood and sexual function. Patients in the intervention group will be asked to complete attendance diaries regarding educational and support services utilized. Participants' clinical data will also be collected. The aim of this study is to help decrease demoralization and sexual dysfunction. The additional education consists of asking patients to attend the Women and Bladder Cancer Educational Series, Women's Bladder Cancer Support Group meetings, referrals to other support services, receiving supplemental handouts and treating physician led counseling incorporated into standard of care visits. There is no treatment offered as part of this study.

The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG, a type of vaccine therapy infused directly into the bladder). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries. There is no treatment provided as part of this study.

The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy (surgery to remove the bladder) improves functional outcomes without comprising cancer outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder (a pouch created from a portion of the small bowel that functions as a bladder) will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety. This study has 2 arms: Arm A: Prostate Capsule-Sparing Radical Cystectomy Patients randomized to this arm will receive the prostate capsule-sparing surgery performed in the form of standard simple prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder. Arm B: Nerve-Sparing Radical Cystectomy Patients randomized to this arm will receive the nerve-sparing surgery will be performed in the form of the standard nerve-sparing radical prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.

A Phase 2/3 Trial of Izalontamab Brengitecan (a type of targeted therapy) versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy. This study has 2 treatment arms: Arm A: Izalontamab Brengitecan alone Arm B: Cisplatin + Gemcitabine + Carboplatin Dosages and dosing schedules will be provided by the treatment site.

This phase III trial compares the effect of adding gemcitabine (a type of chemotherapy) to intravesical Bacillus Calmette Guerin (BCG, a type of immunotherapy) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer. This study has 2 treatment arms: Arm A: BCG alone Patients receive BCG intravesically (instilled directly into the bladder) over 2 hours once per week for 6 weeks, followed by BCG over 2 hours once per week for 3 weeks at months 3, 6 and 12 in the absence of disease progression or unacceptable toxicity. Arm B: BCG + gemcitabine Patients receive gemcitabine intravesically over 1 hour twice weekly on weeks 1 and 10, and once weekly on weeks 4 and 7. Patients also receive BCG intravesically over 2 hours once per week on weeks 2, 3, 6, 8 and 9 followed by gemcitabine intravesically over 1 hour on week 1 and BCG intravesically over 2 hours on week 2-4 at months 3, 6 and 12 in the absence of disease progression or unacceptable toxicity.

This phase III trial compares the effect of adding durvalumab (Imfinzi, a type of immunotherapy) to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone. This study has 3 treatment arms: Arm A: Durvalumab + chemotherapy Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Arm B: Chemotherapy Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Arm C: Durvalumab + Gemcitabine Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510 (a type of targeted therapy) monotherapy (give alone) and in Combination with Cemiplimab (Libtayo, a type of immunotherapy) in participants with previously treated, advanced solid tumors. This study will investigate the safety, tolerability and effectiveness of BHV-1510 given in monotherapy and given in combination with cemiplimab. This study has 2 treatment arms: Arm A: BHV-1510 alone Dosage and dosing schedule will be provided by the treatment site. Arm B: BHV-1510 + Cemiplimab Dosage and dosing schedule will be provided by the treatment site.

Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in Transurethral Resection of Bladder Tumor (TURBT) for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determining the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. This study has 2 arms: Arm A: Blue light Cystoscopy Patients with bladder tumors will undergo BLC TURBT Arm B: White light Cystoscopy Patients with bladder tumors will undergo WLC TURBT

This is a single arm, Phase II trial involving the use of atezolizumab (Tecentriq, a type of immunotherapy) plus platinum (a type of chemotherapy) and etoposide (a type of chemotherapy) for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate (meaning there is no longer any cancer visible on imaging scans) at time of cystectomy (the surgical removal of the bladder) in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide. The study population will include male and female patients over the age of 18 with invasive small cell / neuroendocrine carcinoma of the bladder, with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. This study has 1 treatment arm: Atezolizumab with Platinum and Etoposide, followed by cystectomy. Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of every 21 day cycle (1 cycle = 21 days), with chemotherapy, for 4 cycles. Following cystectomy, Atezolizumab maintenance will continue once every 21 days for up to 1 year. Chemotherapy will include Etoposide given IV on Days 1 - 3 every cycle for the first 4 cycles. Chemotherapy will include either Carboplatin given IV on Day 1 every cycle for the first 4 cycles OR Cisplatin given IV on Day 1 every cycle for first 4 cycles. Cystectomy should be performed within 42 days after completion of last administered study therapy of induction phase (first 4 cycles of chemotherapy). Cystectomy should be performed within 42 days after completion of last administered study therapy (after the first 4 cycles of Atezolizumab + chemotherapy).

The pivotal phase 3 trial evaluating the effectiveness of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with carcinoma in situ (also called CIS or Tis and means there are very early cancer cells in the inner layer of the bladder lining) CIS ± high-grade achieved a complete response (CR, meaning there was no evidence of the cancer remaining) at 3 months. In this trial, the safety and effectiveness of intravesical instillation (instilled directly into the bladder) of nadofaragene firadenovec (ADSTILADRIN, a type of gene immunotherapy) alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS. This study has 3 treatment arms: Arm A: Nadofaragene firadenovec alone Nadofaragene firadenovec is instilled directly into the bladder (intravesically). Dosages and dosing schedule will be provided by the treatment site. Arm B: Nadofaragene firadenovec + gemcitabine + docetaxel Nadofaragene firadenovec, and sequential gemcitabine (Gemzar, a type of chemotherapy) and docetaxel (Taxotere, a type of chemotherapy) will all be given intravesically. Dosages and dosing schedule will be provided by the treatment site. Arm C: Nadofaragene firadenovec + Pembrolizumab Nadofaragene firadenovec is given intravesically. Pembrolizumab (Keytruda, a type of immunotherapy) is given intravenously (IV). Dosages and dosing schedule will be provided by the treatment site.

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec (a type of gene immunotherapy) vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC). This study will assess the effectiveness of Nadofaragene Firadenovec in IRNMIBC. This study has 2 arms: Arm A: Nadofaragene Firadenovec Participants in the nadofaragene firadenovec arm will receive quarterly (once every 3 months) instillations (intravesical, instilled directly into the bladder) with nadofaragene firadenovec for 24 months. Arm B: Observation Subjects will be followed based on the surveillance schedule quarterly over the 24 months treatment period.

The study hypothesis is that patients with non-muscle invasive bladder cancer (NMIBC) who have not received treatment with BCG (a type of immunotherapy infused directly into the bladder) will have equal or better outcomes when treated with intravesical (infused directly into the bladder) Gemcitabine + Docetaxel (GEMDOCE, a type of chemotherapy). The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the standard of care BCG therapy. This study has 2 arms: Arm A: Gemcitabine + Docetaxel Intravesical infusion once a week for 6 consecutive weeks followed by monthly infusions during maintenance for 2 years. Arm B: BCG (Bacillus Calmette Guerin) Intravesical infusion once a week for 6 consecutive weeks during induction followed by weekly infusions for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 months.

This study is being done to see if a drug called disitamab vedotin (a type of targeted therapy), alone or with pembrolizumab (Keytruda, a type of immunotherapy), works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease. All patients will receive treatment with either: Disitamab vedotin alone: Given into the vein (IV; intravenous) every 2 weeks OR Disitamab vedotin + pembrolizumab: Disitamab vedotin is given into the vein (IV; intravenous) every 2 weeks + Pembrolizumab given by IV on Day 1 of each 6-week cycle.

This phase III trial compares the effect of adding durvalumab (Imfinzi, a type of immunotherapy) to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone. This study has 3 treatment arms: Arm A: Durvalumab + chemotherapy Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Arm B: Chemotherapy Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Arm C: Durvalumab + Gemcitabine Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs, sacituzumab govitecan (SG, a type of targeted chemotherapy) and atezolizumab (Tecentriq, a type of immunotherapy), are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with rare GU cancers. The objective of this study is to determine clinical effectiveness of sacituzumab govitecan (SG), either alone or in combination with atezolizumab in participants with rare metastatic non-prostate genitourinary tumors. This study has 2 treatment arms: Arm A: Sacituzumab govitecan Sacituzumab govitecan is administered intravenously (IV) at 10 mg/kg on days 1 and 8 of each 21-day cycle. Arm B: Sacituzumab govitecan PLUS Atezolizumab Sacituzumab govitecan is administered intravenously (IV) at 10 mg/kg on days 1 and 8 of each 21-day cycle PLUS Atezolizumab is administered IV at 1200 mg on day 1 each 21-day cycle.

Many cancers of the testicles and urinary tract are rare diseases; these are diseases that affect less than 200,000 people in the United States. It can be hard to study treatments for these diseases. One combination of drugs enfortumab vedotin (EV, a type of targeted therapy) and pembrolizumab (Keytruda, a type of immunotherapy), has already been approved to treat some urinary cancers. Researchers want to see if they can help people with other types of testicle and urinary cancers. The objective of this study is to test EV, with or without pembrolizumab, in patients with rarer cancers of the testicles or urinary tract. This study has 2 treatment arms: Arm A: Enfortumab vedotin (EV) EV is administered intravenously (IV) at 1.25 mg/kg. Dosing schedule will be provided by treatment team. Arm B: Pembrolizumab + Enfortumab vedotin (EV) Pembrolizumab is administered IV at 200 mg on day 1 of each 21-day cycle. EV is administered intravenously (IV) at 1.25 mg/kg. Dosing schedule will be provided by treatment team.