Study of datopotamab deruxtecan with platinum-based therapy compared to gemcitabine with platinum-based therapy in patients with advanced urothelial cancer after prior treatment
This study focuses on treating patients with Locally Advanced or Metastatic Urothelial Carcinoma, a type of cancer that affects the urinary system, including the bladder, kidney pelvis, ureter, or urethra, and has spread to nearby tissues or other parts of the body. The study will test a new medication called datopotamab deruxtecan (also known as Dato-DXd) in combination with either carboplatin or cisplatin, comparing it to a combination of gemcitabine with carboplatin or cisplatin.
The purpose of this research is to evaluate how well datopotamab deruxtecan works when combined with platinum-based therapy (carboplatin or cisplatin) compared to the standard treatment of gemcitabine with platinum-based therapy. The study is designed for patients whose cancer has progressed during or after previous treatment with enfortumab vedotin and pembrolizumab.
During the study, participants will receive their assigned treatment through intravenous infusion. The medications will be given in cycles, with treatment continuing for up to 120 weeks for datopotamab deruxtecan and up to 5 weeks for the other medications. Throughout the study, doctors will monitor the participants’ response to treatment through various medical examinations and imaging tests.
1Initial medical assessment
You will undergo evaluation to confirm locally advanced or metastatic urothelial carcinoma (cancer in the urinary system).
Your doctor will review your medical history and perform necessary tests to ensure you meet the study requirements.
A tissue sample from your tumor will be required for testing.
2Treatment assignment
You will be randomly assigned to receive one of two treatment combinations:
Option 1: Datopotamab deruxtecan plus either carboplatin or cisplatin
Option 2: Gemcitabine plus either carboplatin or cisplatin
All medications will be given through intravenous infusion (delivered directly into your vein)
3Treatment period
You will receive regular treatment sessions according to your assigned medication combination
Your doctor will monitor your response to treatment through regular imaging scans
Blood tests will be performed to check your body’s response to the treatment
Your overall health status will be regularly assessed
4Monitoring and assessment
Regular physical examinations will be conducted
Imaging scans will track any changes in your cancer
Side effects will be monitored and documented
Quality of life assessments will be performed using questionnaires
5Follow-up period
After completing treatment, you will continue to have regular check-ups
Your health status will be monitored to track long-term outcomes
The study will continue until April 2030
Who Can Join the Study?
Must be 18 years or older when signing the consent form
Must have confirmed urothelial carcinoma (cancer in the urinary system) that is either:
– Advanced and cannot be surgically removed, or
– Has spread to other parts of the body (metastatic)
Must be able to provide a tissue sample from previous tests or agree to a new biopsy
Must be suitable to receive treatment with cisplatin or carboplatin (types of chemotherapy medications)
Must have had disease progression during or after previous treatment with enfortumab vedotin and pembrolizumab (cancer medications). Patients who stopped these treatments due to side effects are eligible if their disease has progressed
Must have cancer that can be measured on CT or MRI scans (imaging tests)
Must have good physical function, with an ECOG performance status of 0 or 1 (able to perform daily activities with minimal assistance)
Must have acceptable levels in laboratory tests showing:
– Good bone marrow function
– Good kidney function
– Good liver function
– Normal blood clotting
Who Cannot Join the Study?
History of active brain metastases (cancer that has spread to the brain) within the last 3 months
Known allergic reactions to platinum-based drugs or similar medications used in the study
Significant heart problems including heart failure or uncontrolled high blood pressure
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Other types of cancer within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
Pregnant or breastfeeding women
Severe kidney or liver problems
Previous treatment with similar cancer medications within the past 4 weeks
Any medical condition that could interfere with the study treatment or affect patient safety
Unable to swallow medications or have conditions that could affect drug absorption
Participation in another clinical trial within the past 4 weeks
Datopotamab Deruxtecan (also known as Dato-DXd) is an antibody-drug conjugate medication that targets specific cancer cells in patients with urothelial carcinoma (bladder cancer and cancers of the urinary system). It works by delivering cancer-fighting medicine directly to tumor cells.
Carboplatin is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell DNA, which helps stop cancer cells from growing and dividing.
Cisplatin is a chemotherapy medication similar to carboplatin. It also works by damaging cancer cell DNA to stop tumor growth and spread.
Gemcitabine is a chemotherapy medication that works by preventing cancer cells from making and repairing DNA, which stops them from multiplying.
Enfortumab Vedotin is an antibody-drug conjugate that targets specific proteins found on cancer cells to deliver cancer-fighting medicine directly to the tumors.
Pembrolizumab is an immunotherapy medication that helps the body’s immune system recognize and fight cancer cells more effectively.
Urothelial Carcinoma – A type of cancer that begins in the cells lining the urinary system, most commonly in the bladder. The disease can develop in the renal pelvis, ureter, bladder, and urethra, affecting the transitional epithelial cells that make up the inner lining of these organs. When described as locally advanced, the cancer has grown into deeper layers of the bladder wall or nearby tissues. In metastatic form, the cancer has spread beyond its original location to other parts of the body, such as lymph nodes, bones, liver, or lungs. The condition typically develops gradually, with the abnormal cells multiplying and forming tumors in the urinary system.
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