This clinical trial is focused on studying treatments for muscle-invasive bladder cancer, a type of cancer that affects the bladder muscle. The study will compare two different treatment approaches. One group of participants will receive a combination of two medications: enfortumab vedotin and pembrolizumab (also known by the code name MK-3475). The other group will receive a combination of gemcitabine and cisplatin, which are commonly used chemotherapy drugs. The purpose of the study is to evaluate which treatment is more effective in improving the outcomes for patients with this type of cancer.
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.
1joining the study
Upon joining the study, you will be assigned to one of two groups. Each group will receive a different treatment plan for muscle-invasive bladder cancer.
2treatment group assignment
If assigned to Arm A, you will receive a combination of enfortumab vedotin and pembrolizumab. These medications are administered through an intravenous infusion, which means they are given directly into your vein.
If assigned to Arm B, you will receive gemcitabine and cisplatin, also administered through an intravenous infusion.
3treatment administration
For Arm A, the treatment with enfortumab vedotin and pembrolizumab will be given before and after surgery. The exact schedule and dosage will be explained by your healthcare provider.
For Arm B, the treatment with gemcitabine and cisplatin will be given before surgery. The exact schedule and dosage will be explained by your healthcare provider.
4surgery
Both groups will undergo a surgical procedure called radical cystectomy (RC) with pelvic lymph node dissection (PLND). This surgery involves the removal of the bladder and nearby lymph nodes.
5post-surgery treatment
After surgery, if you are in Arm A, you will continue to receive enfortumab vedotin and pembrolizumab as part of your treatment plan.
If you are in Arm B, no further chemotherapy is planned after surgery.
6follow-up and monitoring
Throughout the study, regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment. These visits may include physical exams, imaging tests, and laboratory tests.
Who Can Join the Study?
Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) with predominant (50% or more) urothelial histology. This means that a tissue sample from your bladder shows this type of cancer under a microscope.
Have clinically non-metastatic bladder cancer, which means the cancer has not spread to other parts of the body. This is determined by imaging tests like a CT scan or MRI of the chest, abdomen, and pelvis.
Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND). This means your doctor believes you can undergo surgery to remove the bladder and nearby lymph nodes.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some restrictions but can still do light work.
Have adequate organ function, meaning your vital organs like the liver and kidneys are working well enough to handle treatment.
Be within the age range of adults and older adults.
Both male and female participants are eligible.
Who Cannot Join the Study?
Patients who do not have Muscle Invasive Bladder Cancer cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not male or female cannot participate.
Patients who are considered part of a vulnerable population cannot participate.
Enfortumab Vedotin is a type of cancer treatment known as an antibody-drug conjugate. It works by attaching to cancer cells and delivering a powerful drug directly to them, which helps to kill the cancer cells while trying to minimize damage to normal cells. In this trial, it is being used to treat muscle-invasive bladder cancer.
Pembrolizumab, also known as MK-3475, is an immunotherapy medication. It helps your immune system to recognize and attack cancer cells more effectively. It is used in this trial to help treat muscle-invasive bladder cancer by boosting the body’s natural defenses against the cancer.
Gemcitabine is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is used in this trial as part of a treatment plan for muscle-invasive bladder cancer, aiming to shrink the tumor before surgery.
Cisplatin is another chemotherapy medication that helps to kill cancer cells by damaging their DNA. It is often used in combination with other drugs to treat various types of cancer, including bladder cancer, as part of a strategy to reduce the size of the tumor before surgical removal.
Muscle Invasive Bladder Cancer – Muscle Invasive Bladder Cancer is a type of bladder cancer that has spread into the muscle layer of the bladder wall. It typically begins in the cells lining the bladder and progresses deeper into the bladder muscle. As the cancer grows, it can invade surrounding tissues and organs, potentially spreading to other parts of the body. The progression of this disease can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the cancer may cause more severe symptoms as it affects other areas. The disease’s progression is influenced by various factors, including the cancer’s stage and grade.
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