E-Newsletter - May 2024
Spotlight on Alliance Trials


More than 83,000 new cases of bladder cancer will be diagnosed this year, according to estimates from the American Cancer Society. Bladder cancer, while relatively uncommon, originates in the bladder lining. The predominant form, urothelial carcinoma, begins in the urothelial cells lining the bladder interior. Categorically, bladder cancers are classified as non-invasive (affecting the inner layer of cells) or invasive (penetrating deeper layers of the bladder wall) depending on their spread into the bladder wall. Non-muscle invasive bladder cancer (NMIBC) refers to tumors that haven't extended into the muscle layer.

Treatment approaches for bladder cancer are determined by several factors, including the cancer type, grade, and stage, along with the patient's overall health and personal treatment preferences. Possible bladder cancer treatments include surgery, chemotherapy, radiation therapy, immunotherapy, and targeted therapy.

May is National Bladder Cancer Awareness Month!
Alliance has five bladder cancer trials currently open for enrollment.

Take a look.

  • A031701 (Invasive bladder cancer)
  • A031702 (Rare genitourinary cancers)
  • A031803 (Non-muscle invasive bladder cancer)
  • A032103 (Muscle invasive bladder cancer)
  • A032002 (Metastatic urothelial cancer)

A031701 (Invasive bladder cancer)
A phase II study of gemcitabine plus cisplatin chemotherapy in patients with muscle-invasive bladder cancer with bladder preservation for those patients whose tumors harbor deleterious DNA damage response (DDR) gene alterations

The standard therapy for bladder cancer that invades the muscle wall (muscle-invasive bladder cancer) is chemotherapy followed by surgery to remove the bladder. The purpose of this study that Gopakumar Iyer, MD, of Memorial Sloan Kettering Cancer Center, leads is to see if some patients with muscle-invasive bladder cancer can avoid surgery to remove their bladder. This clinical trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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.

Learn more about Alliance A031701 here.


A031702 (Rare genitourinary cancers)
A phase II study of ipilimumab, cabozantinib, and nivolumab in rare genitourinary cancers (ICONIC)

This phase II clinical trial led by Andrea Apolo, MD, of the National Cancer Institute, studies how well cabozantinib s-malate, nivolumab, and ipilimumab work together in treating patients with rare genitourinary (GU) cancers that have spread to other places in the body. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, specifically checkpoint inhibitors, 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 s-malate, nivolumab, and ipilimumab may work better in treating patients with rare GU cancers that have no treatment options compared to giving cabozantinib s-malate, nivolumab, or ipilimumab alone.

Learn more about Alliance A031702 (ICONIC) here.


A031803 (Non-muscle invasive bladder cancer)
Phase II trial of intravesical gemcitabine and MK-3475 (pembrolizumab) in the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer

Michael Woods, MD, of Loyola University Medical Center, leads this clinical trial that studies how well gemcitabine together with pembrolizumab works in treating patients with non-muscle invasive bladder cancer (NMIBC) who are unresponsive to the bacillus Calmette-Guérin (BCG) vaccine. NMIBC accounts for about 70 percent of all bladder cancer and is associated with a more than 88 percent survival rate over five years. Despite significant advances in the management of NMIBC, it remains associated with significant morbidity and mortality due to its tendency to recur and progress to muscle-invasive or systemic disease. This trial may have a significant impact on future research.

The results of this trial may provide a novel treatment approach to this patient population and support the importance of additional research combining intravesical therapy (injecting drug directly into the bladder) with immune checkpoint inhibition. Conversely, the results may direct urologic research toward different combinations of therapies for BCG-unresponsive non-muscle invasive bladder cancer.

Learn more about Alliance A031803 here.


A032002 (Metastatic urothelial cancer)
Phase II randomized trial of atezolizumab versus atezolizumab and radiation therapy for platinum ineligible/refractory metastatic urothelial cancer (ART)

This phase II clinical trial led by Himanshu Nagar, MD, of Weill Cornell Medicine, compares the effect of adding radiation therapy to an immunotherapy drug called atezolizumab vs. atezolizumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). The addition of radiation to immunotherapy may shrink the cancer, but it could also cause side effects. Immunotherapy with monoclonal antibodies such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 

Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. The combination of atezolizumab and radiation therapy may be more efficient in killing tumor cells.

Learn more about Alliance A032002 (ART) here.


A032103 (Muscle invasive bladder cancer)
MODERN: An integrated phase 2/3 and phase 3 trial of MRD-based optimization of ADjuvant ThErapy in URothelial CaNcer

Matthew Galsky, MD, of The Tisch Cancer Institute, leads this phase II/III clinical trial that 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 and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help 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.

Learn more about Alliance A032103 (MODERN) here.


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