E-Newsletter - March 2025
Spotlight on Alliance Trials
Five important clinical trials focused on innovative treatments for colorectal and bladder cancer are spotlighted in observance of National Colorectal Cancer Awareness Month. These trials aim to improve outcomes and advance cancer care.
- A022101 (Limited metastatic colorectal cancer)
- A022104 (Advanced rectal cancer)
- A031701 (Invasive bladder cancer)
- A031803 (Non-muscular invasive bladder cancer)
- A032103 (Muscle invasive bladder cancer)
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States, affecting both men and women nearly equally. Those with a family history of CRC face a 10 to 15 percent higher risk of developing the disease. Below are the current CRC trials actively enrolling participants.
A022101 (ERASur: Limited metastatic colorectal cancer)
This clinical trial led by Eric Miller, MD, PhD, of Ohio State University Comprehensive Cancer Center, compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to four body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites.
Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.
Official title: A pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur)
Learn more: https://bit.ly/Alliance-A022101
********************************************************************
A022104/NRG-GI010 (Advanced rectal cancer)
This phase II clinical trial led by J. Joshua Smith, MD, PhD, of Memorial Sloan Kettering Cancer Center, compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Official title: A randomized phase II trial testing the efficacy of triplet versus doublet chemotherapy to achieve clinical complete response in patients with locally advanced rectal cancer
Learn more: https://bit.ly/Alliance-A022104
*****************************************************************************************************************
Bladder cancer, though relatively rare, begins in the bladder's lining. The most common type, urothelial carcinoma, starts in the urothelial cells that line the bladder. Bladder cancers are classified as non-invasive (affecting only the inner layer of cells) or invasive (spreading to deeper layers of the bladder wall). Non-muscle invasive bladder cancer (NMIBC) refers to cases that haven't yet reached the muscle layer. Below are active bladder cancer trials currently enrolling participants.
A031701 (Invasive bladder cancer)
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.
Official title: 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
Learn more: https://bit.ly/AllianceA031701
********************************************************************
A031803 (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.
Official title: Phase II trial of intravesical gemcitabine and MK-3475 (pembrolizumab) in the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer
Learn more: https://bit.ly/AllianceA031803
********************************************************************
A032103 (MODERN: Muscle invasive bladder cancer)
Matthew Galsky, MD, of Mount Sinai Medical Center, leads this 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 doctors 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.
Official title: MODERN: An integrated phase 2/3 and phase 3 trial of MRD-based optimization of ADjuvant ThErapy in URothelial CaNcer
Learn more: https://bit.ly/Alliance-A032103
