E-Newsletter - May 2022
Spotlight on Alliance Trials


May is National Bladder Cancer Awareness Month. Every year, more than 570,000 people are diagnosed with bladder cancer. It is the 10th most commonly diagnosed cancer worldwide and the sixth most common cancer in the United States. Most tumors develop on the inner layer of the bladder. Some can grow into deeper bladder layers. As cancer grows through these layers into the muscle wall, it becomes harder to treat. Urothelial cells are also found in the kidneys and the ureters, the tubes that connect the kidneys to the bladder. Bladder cancer can happen in the kidney and ureters, as well, though much less frequently.

Risk factors for bladder cancer include gender, age, race, and genetics. About one in 100 men and one in 400 women will be diagnosed with bladder cancer, worldwide. It is the sixth most common cancer in men and 17th most common cancer in women. It is said that cigarette smoking is the number one risk factor for bladder cancer.

In recognition of National Bladder Cancer Awareness Month, let’s take a look at the active trials in the Alliance portfolio.

Gopakumar Iyer, MD, of Memorial Sloan Kettering Cancer Center, leads Alliance A031701 (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). This trial looks at how well drugs (gemcitabine hydrochloride and cisplatin) work in treating patients 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. This trial opened on August 1, 2018. To learn more about this trial, visit http://bit.ly/AllianceA031701.

Michael Woods, MD, of Loyola University Medical Center, leads Alliance A031803 (Phase II trial of intravesical gemcitabine and MK-3475 (pembrolizumab) in the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer). This phase II trial 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. The trial opened on January 6, 2020. To learn more about this trial, visit http://bit.ly/AllianceA031803.

Xiao X. Wei, MD, MAS, of Dana-Farber Cancer Institute, leads Alliance A031901 (Duration of immune checkpoint therapy in locally advanced or metastatic urothelial carcinoma: A randomized phase III non-inferiority trial (IMAGINE). The phase III IMAGINE trial compares survival in patients with urothelial cancer who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients. This trial opened on December 10, 2020. To learn more about the IMAGINE trial, visit https://bit.ly/AllianceA031901

Shilpa Gupta, MD, of the Cleveland Clinic, leads Alliance A032001 (MAIN-CAV: Phase III randomized trial of maintenance cabozantinib and avelumab vs maintenance avelumab after first-line platinum-based chemotherapy in patients with metastatic urothelial cancer). This phase III MAIN-CAV rial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, 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 and avelumab together may further shrink the cancer or prevent it from returning/progressing. The trial opened on March 10, 2022. To learn more about this MAIN-CAV trial, visit https://bit.ly/Alliance-A032001.

Himanshu Nagar, MD, of Weill Cornell Medicine, leads Alliance A032002 (Phase II randomized trial of atezolizumab versus atezolizumab and radiation therapy for platinum ineligible/refractory metastatic urothelial cancer (ART)). This phase II ART trial 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. This trial opened on December 1, 2021. To learn more about the ART trial, visit https://bit.ly/Alliance-A032002



For other articles in this issue of the Alliance E-news Newsletter, see below: