In the study, treatment is given before surgery, and then the planned surgery is performed if possible. During the study, there are regular checkups, blood tests, and other routine medical exams to watch for side effects and to see how the disease is responding. After surgery, follow-up continues for a period of time to look for any return of the cancer and to monitor overall health.

Durvalumab is a type of medicine that helps the immune system attack cancer cells. The chemotherapy used with it is ddMVAC, a group of cancer medicines that are commonly given together for bladder cancer. The study is open-label, which means both the medical team and the participant know which treatment is being given.

The purpose of this study is to test the effectiveness and safety of a new drug called vepugratinib compared to a placebo. Participants in the study will receive a combination of treatments. This includes vepugratinib or a placebo taken as an oral tablet, along with enfortumab vedotin and pembrolizumab, which are administered through intravenous use, meaning they are delivered directly into a vein. The study is designed so that neither the participants nor the researchers know which specific treatment is being administered during the process.

During the study, participants will undergo regular medical monitoring to track the progress of the treatment. The involvement in this clinical trial may last for up to approximately 6 years.

Participants in the study may receive MK-2870 through an intravenous infusion, which is a method of delivering medicine directly into a vein. Other participants will receive a choice of different chemotherapy drugs selected by the doctor, such as docetaxel, vinflunine, or paclitaxel. Some participants may also be given colony stimulating factors, which are substances used to help the body produce more white blood cells, or corticosteroids, which are medicines used to reduce swelling or inflammation.

The purpose of this study is to investigate the cardiovascular side effects of immune checkpoint inhibitors, which means looking at how these cancer treatments might affect the heart and blood vessels. The study will monitor patients who are receiving these treatments as part of their regular cancer care. During the study, doctors will check for various heart-related problems that might develop or get worse during treatment. The treatment period with these medicines can last up to twelve months.

The main focus of the study is to track serious heart-related events, including death from heart problems, heart attacks, strokes, chest pain that requires hospital care or urgent treatment to restore blood flow to the heart, and hospital stays due to heart failure (when the heart cannot pump blood well enough). The study will also look at other heart and blood vessel problems such as new or worsening high blood pressure, irregular heartbeats, blood clots in the veins, and other heart-related issues that require hospital admission. This research aims to better understand how these cancer treatments affect the heart and blood vessels so that doctors can better monitor and care for patients receiving these medicines.

During the study, patients will undergo the standard surgery to remove their diseased bladder and create a new one from intestinal tissue. At the same time, the expanded autologous urothelial cells, which are the patient’s own bladder lining cells, will be placed onto the inside of the new bladder using the bioprinter. The study will monitor patients for any serious problems such as death, rejection of the new bladder, or the need for additional surgery to fix complications. Doctors will also watch for any side effects or complications that happen during or after the surgery.

The study will also look at how well the bioprinter works and whether it is easy to use during surgery. Patients will be checked to see if the new bladder functions properly, including whether they can control urination, if there is mucus production, and if there are any chemical imbalances in the blood. Tissue samples will be examined to see how well the bladder lining cells have grown on the new bladder. The study will also measure changes in quality of life to understand how patients feel after the treatment.

The main purpose of this research is to determine how long patients can live without their disease getting worse or requiring additional treatments when using this drug combination. The study will monitor patients to see if the tumor becomes smaller and to evaluate how well they tolerate the treatment. The medications work in different ways – Sacituzumab Govitecan targets cancer cells directly, while Zimberelimab helps the body’s immune system fight the cancer.

During the study, participants will receive regular treatments with both medications. Their condition will be monitored through various medical examinations and imaging tests to check how the cancer responds to the treatment. The treatment period may last up to 48 weeks, depending on how well patients respond to the therapy and whether they experience any side effects.

The purpose of the study is to assess the short-term effects of these cancer treatments on speech perception in noise. Participants will undergo various assessments to measure changes in their ability to understand speech in noisy settings, as well as changes in their hearing and cognitive functions. The study will also evaluate the impact of these treatments on the participants’ quality of life related to hearing. The trial will follow participants from the start of their treatment and include follow-up visits to monitor any changes over time.

By participating in this study, researchers aim to gain a better understanding of how cancer treatments affect important aspects of daily life, such as communication and cognitive abilities. This information could help improve future treatment plans and support services for individuals undergoing cancer therapy. The study is expected to continue until the end of 2031, with recruitment starting in August 2024.

The study will observe how well these methods help in removing the bladder tumor completely and whether there is any remaining cancer or changes in the cancer stage when the procedure is repeated. Participants will be randomly assigned to either the PDD or WL group. The study will also look at the recurrence of cancer three months after the procedure, the quality of life of participants, and any side effects experienced. Quality of life will be assessed using specific questionnaires designed for bladder cancer patients.

The trial aims to provide valuable information on the effectiveness of using PDD compared to WL during TURB for patients with NMIBC. This could potentially lead to better treatment outcomes and improved quality of life for patients with this type of bladder cancer. The study is expected to continue until 2028, with recruitment starting in 2025.

The purpose of the study is to compare the effectiveness of using mRNA-4157 in combination with the BCG vaccine against using the BCG vaccine alone. Participants will be randomly assigned to receive either the combination of mRNA-4157 and BCG or just the BCG vaccine. The study will also look at how well mRNA-4157 works on its own. The treatments will be given over a period of time, and participants will be monitored to see how their cancer responds to the treatments.

Throughout the study, participants will receive regular check-ups to monitor their health and the progress of their cancer. The study aims to provide valuable information on whether the combination of mRNA-4157 and BCG can improve outcomes for people with high-risk non-muscle invasive bladder cancer compared to the BCG vaccine alone. This research could lead to new treatment options for patients with this type of bladder cancer.

The purpose of this study is to see if using avelumab for a short period, up to six months, can help patients with advanced urothelial cancer live longer. These patients have already received chemotherapy that includes platinum-based drugs, and their cancer has not worsened during or after this initial treatment. The study will observe patients over a period of 18 months to determine if the treatment improves their overall survival.

Participants in the study will receive either the avelumab treatment or a placebo. The study will monitor the patients’ health and response to the treatment over time, focusing on how long they live and how their cancer responds to the treatment. The trial aims to provide valuable information on whether avelumab can be an effective maintenance therapy for patients with this type of cancer.

The purpose of the study is to evaluate how effective and safe EG-70 is when given directly into the bladder. The study will observe patients over a period of time to see if the cancer responds to the treatment. Patients will receive the treatment through a process called intravesical administration, which means the medication is delivered directly into the bladder. The study will monitor the patients’ response to the treatment at different intervals, such as 12, 24, 36, and 48 weeks, to see if there is a complete response, meaning no signs of cancer are found.

Throughout the study, the safety of EG-70 will be closely monitored by checking for any side effects. The trial will also look at how the treatment affects the patients’ quality of life and other health markers. The study aims to provide valuable information on whether EG-70 can be a beneficial treatment option for patients with NMIBC who have limited options due to their cancer not responding to or completing BCG treatment.

The purpose of the study is to learn more about how well the treatment works and how safe it is for participants. The study will involve taking the medication by mouth for a period of up to 36 months. Participants will be monitored regularly to see how their tumors respond to the treatment and to check for any side effects. The study will also look at how long the treatment keeps the disease under control and how it affects the overall health and quality of life of the participants.

Participants in the study will have regular check-ups and tests to track their progress. These tests will help researchers understand the effectiveness of the treatment and any potential risks. The study aims to provide valuable information that could lead to better treatment options for people with these types of tumors in the future.

The purpose of the study is to assess how well patients with this type of bladder cancer respond to the treatment in terms of progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse. Participants in the study will receive the treatment through a method called intravesical use, where the solution is directly instilled into the bladder. The study will monitor patients over a period of time to see how the cancer responds to the treatment and to evaluate any side effects or adverse reactions that may occur.

Throughout the study, various aspects will be observed, including the rate at which the cancer progresses at 12 and 24 months, the overall survival without disease recurrence, and the quality of life of the participants. The study will also look at the body’s immune response to the treatment by analyzing certain proteins in the urine. This trial aims to provide valuable information on the effectiveness and safety of IMUNO BCG Moreau RJ in preventing the progression of high-risk non-muscle invasive bladder cancer.

The purpose of the study is to investigate how effective this combination of treatments is in preventing the return of cancer in patients with this type of bladder cancer. Participants will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will also include radiotherapy, a treatment that uses high-energy rays to target and kill cancer cells. The trial will monitor patients over a period to assess their response to the treatment and any side effects they may experience.

Throughout the study, researchers will collect data to understand the safety and effectiveness of the treatment combination. They will look at how many patients remain free of cancer, how many might need additional surgery, and the overall quality of life of the participants. The study aims to provide valuable information that could help improve treatment options for patients with muscle-invasive bladder cancer in the future.

Participants in the study will receive UGN-102 as a primary treatment to see if it can effectively remove the cancer. The study will follow a single-arm design, meaning all participants will receive the same treatment without a comparison group. The treatment period will last for a maximum of six weeks, and the participants will be monitored for any changes in their condition. The study will assess the cancer’s response to the treatment at various points, including three months after the first dose.

Throughout the study, the safety of UGN-102 will be closely monitored by checking for any side effects or adverse reactions. Participants will undergo regular check-ups, including physical exams and laboratory tests, to ensure their well-being. The study aims to provide valuable information on the potential of UGN-102 as a treatment option for patients with low-grade NMIBC, helping to determine if it can effectively reduce or eliminate the cancer while maintaining a good safety profile.

The trial will include patients with various types of advanced cancers, such as non-small cell lung cancer, renal cell carcinoma, urothelial bladder cancer, head and neck squamous cell cancer, breast cancer, gastric or gastroesophageal adenocarcinoma, epithelial ovarian cancer, cervical cancer, endometrial adenocarcinoma, prostate cancer, and soft tissue sarcoma. The study will be conducted in two phases. The first phase will focus on finding the right dose of JK06 by gradually increasing the amount given to patients. The second phase will involve giving the selected dose to more patients to further evaluate its effects.

Throughout the study, patients will receive the treatment every three weeks and will be monitored closely for any side effects or changes in their condition. The goal is to gather information that will help in developing JK06 as a potential treatment option for people with these types of advanced cancers. The study is expected to continue until 2028, with recruitment starting in 2024.

The purpose of the study is to evaluate how well patients do when their bladder is left intact after receiving sasanlimab. The study will follow patients for 12 months after they start the treatment to see how many are alive and have not needed surgery to remove the bladder, known as a cystectomy. Patients will receive sasanlimab after they have already undergone a type of chemotherapy called neoadjuvant therapy, which is given before the main treatment to shrink the tumor. The study will also look at other outcomes, such as the response to treatment, survival without the cancer spreading, and overall survival.

Participants in the study will receive regular injections of sasanlimab and will be monitored closely by healthcare professionals. The study will also assess the quality of life of participants using a questionnaire designed to understand how the treatment affects their daily lives. The trial aims to provide valuable information on whether sasanlimab can be an effective treatment option for preserving the bladder in patients with muscle-invasive bladder cancer.

The purpose of this study is to compare the effects of continuing standard immunotherapy with a reduced dose of the same treatment. The medications being studied include Pembrolizumab, Durvalumab, Avelumab, Nivolumab, Dostarlimab, Atezolizumab, and Cemiplimab. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. Some patients will receive the standard dose of these medications, while others will receive a reduced dose every three months.

The study will last for up to three years, during which time patients will continue to receive their assigned treatment. The main goal is to see if the reduced dose is as effective as the standard dose in keeping the cancer from getting worse. Patients will have regular check-ups and assessments to monitor their health and the progress of their cancer. The study will also look at other factors, such as the quality of life and any side effects experienced by the patients. This research aims to find the best way to use immunotherapy to treat cancer effectively while minimizing side effects.

The purpose of this study is to evaluate the effectiveness of the combination of visugromab and an anti-PD-1 checkpoint inhibitor compared to the anti-PD-1 checkpoint inhibitor alone. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will last for a period of up to 12 months, during which participants will be closely monitored by healthcare professionals. The study aims to assess how well the treatment works in reducing the size of the tumor and improving the overall health of the participants.

Throughout the study, participants will undergo various assessments, including imaging tests like computed tomography (CT) and magnetic resonance imaging (MRI), to evaluate the response of the cancer to the treatment. The study will also monitor for any side effects or adverse reactions to the medications. The ultimate goal is to determine if this new combination of treatments can provide a more effective option for patients with muscle-invasive bladder cancer who are unable or unwilling to receive traditional chemotherapy treatments.

Participants in the study will receive either erdafitinib alone or a combination of erdafitinib and cetrelimab. The study will monitor the response of the cancer to these treatments, particularly looking for any reduction in the size of the tumor or complete disappearance of the cancer. The study will also assess the safety of the treatments by keeping track of any side effects experienced by the participants. The trial is designed to help understand if these treatments can be effective options for patients with MIBC who have specific changes in their cancer cells known as FGFR gene alterations.

The study will take place over a period of time, during which participants will receive the treatments and undergo regular check-ups to monitor their health and the progress of the cancer. The goal is to gather information that could lead to new treatment options for patients with muscle-invasive bladder cancer who are not able to use standard chemotherapy. This research is important for developing new ways to manage and treat this type of cancer, potentially improving outcomes for patients in the future.

The purpose of this research is to determine how safe the medication is, how it moves through the body, and how effective it is in treating these types of cancer. The study is divided into two parts. In the first part, different doses of the medication will be tested to find the most appropriate amount. In the second part, researchers will evaluate how well the medication works in treating the cancer.

During the study, participants will take CYC140 once daily for 28-day cycles. The treatment will continue as long as it remains beneficial for the patient. Throughout the study, doctors will monitor patients’ health status and how their cancer responds to the treatment. Various medical assessments will be performed to track the progress of the treatment and ensure patient safety.

The purpose of the study is to evaluate how effective and safe UGN-103 is in treating this type of bladder cancer. Participants in the study will receive the treatment and will be monitored over a period of time to see how well the cancer responds. The study will involve regular check-ups, including procedures like cystoscopy, which is a way to look inside the bladder, and urine tests to check for cancer cells. The study will also track any side effects or reactions to the treatment to ensure it is safe for patients.

Throughout the study, the main goal is to see if the treatment can successfully remove the cancer and prevent it from returning. Participants will be followed for several months to observe the long-term effects of the treatment. This research aims to provide new insights into treating Nonmuscle Invasive Bladder Cancer and potentially offer a new option for patients with this condition.

The study will use two different treatment approaches. Some patients will receive nivolumab alone, while others will receive a combination of nivolumab and ipilimumab. Both medications are given through an intravenous infusion, which means they are delivered directly into a vein. The medications being tested are designed to boost the immune system’s ability to detect and destroy cancer cells.

During the study, doctors will monitor how patients respond to the treatment and track any side effects that may occur. The study will look at whether tumors shrink or stop growing in response to the treatment, and how long patients survive without their cancer getting worse. This research may help develop new treatment options for patients with these types of advanced cancers.

The purpose of this research is to evaluate how well these treatments work in preventing the cancer from returning or getting worse. BCG is a type of bacteria that helps stimulate the immune system to fight cancer cells, while mitomycin-C is a chemotherapy drug that directly kills cancer cells. Both medications are given as a solution that is placed into the bladder.

The treatment period lasts up to 12 months, during which participants receive either BCG alone or BCG followed by electromotive mitomycin-C treatments. The maximum dose of BCG is 3000 million colony forming units per treatment, while the maximum dose of mitomycin-C is 40 milligrams per treatment. Throughout the study, doctors monitor participants to check if the cancer returns or progresses.

Participants in the study will receive the treatment over a period of time, and the study will monitor the response to the treatment. The main goal is to see if the treatment can completely remove visible tumors from the bladder. The study will also look at other outcomes, such as the overall response to the treatment, any side effects that occur, and how the treatment affects the quality of life of the participants.

This study is designed to provide important information about the potential benefits and risks of using GEMSOL for treating low-grade bladder cancer. The results will help determine if this treatment could be a useful option for patients with this condition in the future.

The treatment plan involves receiving Tecentriq (atezolizumab) as an intravenous solution, with each dose containing 1,200 milligrams of medication. Patients will receive treatment for up to 12 months. During this time, some patients will receive both atezolizumab and BCG bladder treatments, while others will receive only BCG treatments.

Throughout the study, patients will have regular check-ups to monitor their health. These visits include medical examinations and quality of life assessments. The doctors will track how long patients remain free from cancer events and watch for any signs that the disease has returned or gotten worse. Blood and urine samples will be collected to study how the treatment is working.

Participants in the study will be divided into different groups. One group will receive pembrolizumab along with a surgical procedure called a cystectomy, which involves removing the bladder. Another group will receive both pembrolizumab and enfortumab vedotin, along with the cystectomy. There is also a group that will undergo the cystectomy alone. The study will observe how these treatments affect the participants over time, focusing on how long they remain free from cancer-related events and their overall survival.

The study aims to provide valuable information on the potential benefits of combining these medications with surgery for patients who cannot or choose not to receive a common chemotherapy drug called cisplatin. By comparing these different approaches, researchers hope to find more effective treatment options for individuals with muscle-invasive bladder cancer. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein.

The purpose of the study is to evaluate how effective these medications are when used together before and after surgery in patients who cannot or choose not to receive a common chemotherapy treatment called cisplatin. The study will observe how well the combination of these medications works in eliminating the cancer from the bladder and nearby lymph nodes, as well as their impact on the patient’s survival and the cancer’s return.

Participants in the study will receive the medications over a period of time before undergoing surgery to remove the bladder. The study will also monitor the safety and side effects of the treatment combination. The goal is to understand if this combination can be a beneficial treatment option for patients with muscle invasive bladder cancer who are not suitable for cisplatin-based chemotherapy.

The purpose of the study is to assess the safety and tolerability of these treatments, which means checking for any side effects and determining how well patients can handle the medications. The study will also gather preliminary information on how effective these treatments are in managing the disease. Participants will receive the medications in different doses and combinations to find the most effective and safest way to use them. The trial will also explore if a more convenient dosing schedule can be established for patients.

Throughout the study, participants will be monitored for any adverse events, which are unwanted effects that may occur during treatment. The trial will also measure how the body processes the medications, including how long they stay in the body and how they are eliminated. The study will continue until the estimated end date in 2026, with the goal of providing valuable information on the potential benefits of Relatlimab and Nivolumab for treating advanced solid tumors.

The purpose of this study is to determine how well this treatment plan works and how safe it is for patients with muscle-invasive bladder cancer. The study will involve several stages, starting with the combination treatment before surgery, followed by surgery, and then continuing with Durvalumab alone. Patients will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over a period to assess the treatment’s effectiveness and any side effects.

Participants in the study will be closely observed to see how their cancer responds to the treatment and to ensure their safety throughout the process. The study aims to provide valuable information that could improve treatment options for people with muscle-invasive bladder cancer in the future.

The purpose of the study is to compare how long participants remain free from the disease after receiving the treatments. The study will involve the use of gemcitabine hydrochloride, which is a chemical substance used in chemotherapy, and mitomycin, another chemotherapy drug. These medications will be administered directly into the bladder, a method known as intravesical use. The study will also involve the use of a device called a urinary placement catheter, which helps deliver the treatment directly to the bladder.

Participants will be randomly assigned to receive either the TAR-200 treatment or the chemotherapy chosen by their doctor. The study will monitor the participants over a period to observe the recurrence of cancer, any progression of the disease, or any other significant health events. The trial aims to provide valuable information on the effectiveness of these treatments in managing HR-NMIBC and improving the quality of life for those affected by this condition.

The purpose of this study is to evaluate how effective atezolizumab is when used as a maintenance therapy after patients have received a combination of chemotherapy and radiotherapy. This is specifically for patients who are not able to undergo a surgery called radical cystectomy, which involves removing the bladder. The study aims to see if atezolizumab can help patients remain free of cancer for a longer period, specifically looking at disease-free survival over two years.

Participants in the study will first receive standard chemotherapy and radiotherapy. After completing this initial treatment, they will begin receiving atezolizumab. The study will monitor the participants over time to assess their health and any changes in their cancer status. The goal is to determine if atezolizumab can help maintain the benefits of the initial treatment and improve outcomes for patients with muscle-invasive bladder cancer. Some participants may receive a placebo instead of atezolizumab to compare the effects of the treatment. The study will also look at other factors such as overall survival, local control of the cancer, and the quality of life of the participants.

The purpose of the study is to determine if adding nivolumab, with or without BMS-986205, to chemotherapy before surgery can improve outcomes for patients with muscle-invasive bladder cancer. Participants will be randomly assigned to one of the treatment groups. After receiving the initial treatment, participants will undergo surgery to remove the bladder cancer. Following surgery, some participants will continue to receive nivolumab, with or without BMS-986205, to see if it helps prevent the cancer from returning.

The study will last for a period of time, during which participants will receive their assigned treatments and be monitored for any changes in their condition. The researchers will be looking at various outcomes, such as the rate of complete response to the treatment, which means no signs of cancer are found after treatment, and event-free survival, which refers to the length of time participants remain free from cancer-related events. The study will also track overall survival and any side effects or adverse events that may occur during the trial.

The purpose of the study is to determine if this combination of atezolizumab and radiotherapy can lead to a complete response in patients, which means that the cancer is no longer detectable. Participants in the study will receive atezolizumab and radiotherapy over a period of time, and their response to the treatment will be monitored. The study will assess the effectiveness of the treatment based on specific criteria used to measure cancer response.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to observe any changes in their condition. The study is designed to provide valuable information about the potential benefits of combining atezolizumab with radiotherapy for treating muscle-invasive bladder cancer, with the hope of improving outcomes for patients with this type of cancer.

The purpose of the study is to see if Sasanlimab, either by itself or with BCG, can help improve the outcomes for patients with high-risk non-muscle invasive bladder cancer. The study will include participants who have not previously received BCG treatment, as well as those whose cancer did not respond to BCG. Participants will be randomly assigned to receive either Sasanlimab with BCG, Sasanlimab alone, or BCG alone. The study will monitor participants over a period to assess how well the treatments work in preventing the cancer from returning or progressing.

Throughout the study, participants will receive regular injections of the treatment and will be closely monitored by healthcare professionals. The study aims to provide valuable information on the effectiveness of Sasanlimab in treating non-muscle invasive bladder cancer, potentially offering new options for patients with this condition. The trial is expected to continue until 2026, with ongoing assessments to determine the best treatment approach for this type of cancer.

The purpose of the study is to assess the safety and tolerability of AZD9574 in patients with these advanced cancers. Participants will receive the medication in the form of a film-coated tablet taken orally. The study will monitor how the body processes the drug, its effects on the cancer, and any side effects that may occur. Some participants may receive a placebo for comparison. The study will also explore how the drug affects specific biomarkers, which are indicators of how the body is responding to the treatment.

Throughout the study, participants will undergo regular health checks, including blood tests and imaging scans, to track their progress and the impact of the treatment. The study aims to gather information over a period of time to determine the potential benefits and risks of AZD9574 for treating these types of cancers. This research is important for developing new treatment options for patients with advanced solid tumors.

The purpose of the study is to determine how well these combinations work in treating patients with this type of cancer. Participants in the study will receive treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will compare the outcomes of patients receiving the different treatment combinations to see which is most effective in improving overall survival and controlling the disease.

Throughout the study, participants will be monitored to assess their response to the treatment and any side effects they may experience. The trial aims to provide valuable information on the potential benefits of combining durvalumab and tremelimumab with chemotherapy for patients with advanced urothelial cancer, helping to guide future treatment options for this condition.

Participants in the study will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will compare the results of using these medications with the results of surgery alone. The trial will last for a period of time, during which the safety and effects of the treatment will be closely monitored. This includes checking for any side effects and assessing how well the treatment works in preventing the cancer from returning or spreading.

The study aims to provide valuable information on the potential benefits of using Durvalumab, Tremelimumab, and Enfortumab Vedotin together for treating Muscle Invasive Bladder Cancer. It will also look at the overall survival rates of patients, the time it takes for the disease to return, and the quality of life of participants. The trial is expected to continue until 2028, with the hope of finding a more effective treatment option for patients with this type of cancer.

The purpose of this study is to evaluate how effective and safe BI 907828 is when used alone in treating these cancers. The study will involve patients who have specific genetic characteristics, such as MDM2 amplification and TP53 wild-type status, which are important for the treatment to potentially work. Participants will take the medication in the form of a film-coated tablet by mouth. The study will monitor the patients over a period of time to see how their cancer responds to the treatment and to check for any side effects.

Throughout the study, patients will be closely observed to assess the treatment’s impact on their cancer and overall health. The study aims to gather information on how long the treatment can control the disease, how long patients live after starting the treatment, and any changes in their quality of life. This information will help determine if BI 907828 could be a beneficial treatment option for these types of cancer in the future.

Participants in the study will be randomly assigned to one of the two treatment groups. Those in the first group will receive enfortumab vedotin and pembrolizumab, while those in the second group will receive gemcitabine and cisplatin. All treatments will be administered through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period of time to monitor their health and the progression of their cancer.

The main goal of the study is to compare the event-free survival, which refers to the length of time participants remain free from certain negative events related to their cancer. Additionally, the study will look at other outcomes such as overall survival, which is the length of time participants live after starting the treatment, and the rate of complete response, which means the cancer has disappeared after treatment. Participants’ quality of life will also be assessed throughout the study to understand the impact of the treatments on their daily lives.