Bladder cancer research is continuously advancing, from new developments to best standards of care. Explore the links and research highlights below to stay informed and learn more about the latest advancements in the field.
Bladder Cancer Research & Studies
Summaries
Impact of Computational Histology AI Biomarkers on Clinical Management Decisions in Non-Muscle Invasive Bladder Cancer: A Multi-Center Real-World Study
A study was done to see whether an artificial intelligence (AI)–based pathology test can improve how doctors manage high‑grade non–muscle‑invasive bladder cancer. This “computational histology” tool (Vesta Bladder) reads routine tumour slides and predicts both the risk that the cancer will recur or progress and how likely it is to respond poorly to BCG treatment. In 105 real‑world cases across six centres, urologists recorded their treatment plan before and after seeing the AI report, and they changed the main management decision in about two‑thirds of patients after viewing the results—most often by switching intravesical therapy when the AI suggested BCG resistance. In some patients, the AI results supported moving earlier to bladder removal (cystectomy) because of very high risk, while in others it gave confidence to continue bladder‑sparing treatment with adjusted follow‑up. Overall, the study suggests that AI‑generated slide analysis can meaningfully influence real‑world decisions and help personalize care for people with high‑risk early‑stage bladder cancer.
Note: This summary was based on research and findings from the following published paper in Cancers by Packiam, V et al., (Jan 2026; https://www.mdpi.com/2072-6694/18/2/249)
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/ INTerpath-005)
ClinicalTrials.gov ID: NCT06305767
Researchers are investigating new treatments for high-risk muscle-invasive urothelial carcinoma (MIUC). MIUC is a bladder cancer that starts in cells lining the inside of the bladder and urinary tract, like the kidneys and urethra. The standard treatment for MIUC is a course of chemotherapy before surgery that removes the tumour. Depending on the patient’s case, after surgery, more medicine is given to stop the cancer from returning. A drug that is commonly used in these cases is pembrolizumab. It is an immunotherapy drug which is a compound that increases the ability of the immune system to destroy cancer cells. To increase the amount of pembrolizumab that reaches cancer cells, researchers use enfortumab vedotin (EV), an antibody drug conjugate (ADC). ADCs can bind to specific proteins only located on cancer cells to deliver the treatment that destroys them. In this clinical trial, scientists are studying the effects of a new treatment, intismeran autogene (V940) in combination with pembrolizumab. Intismeran autogene is a personalized vaccine treatment that uses unique mutations in an individual’s cancer to train the immune system to target cancer cells. Researchers want to find out whether V940 taken with pembrolizumab is better than pembrolizumab alone, whether EV affects these treatments, and the general safety of pembrolizumab, EV, and V940.
Note: This summary was based on research and findings from ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06305767.
Subcutaneous Administration of Nivolumab Approved in Quebec Public Drug Plans, Making this Time-Efficient Treatment More Accessible
In December 2025, Quebec became the first Canadian province to publicly fund a new form of the immunotherapy drug Opdivo (nivolumab) that is given as a quick injection under the skin (subcutaneous injection or SC) Opdivo is an antibody-based immunotherapy drug known as a checkpoint inhibitor, which works by targeting a protein on the surface of cancer cells that offers them protection. Until now, Opdivo has usually been given through intravenous (IV) infusion. Subcutaneous (SC) administration is less invasive than IV and more efficient for patients, going from a typical IV infusion time of 30-60 minutes down to 3-5 minutes by SC injection. The proposed effects of the transition to Opdivo SC in Canada are freeing up 30 000 hours of infusion chair time for patients as well as 64 000 hours of health care professional time over three years. Setting a precedent for the rest of Canada, Quebec’s inclusion of Opdivo SC contributes to quicker treatment times and higher patient satisfaction.
Note: This summary was based on research and findings from the BMS page: https://www.bms.com/ca/en/media/press-release-listing/2025-09-23-press-release.html
ctDNA-Guided Immunotherapy following Radical Cystectomy for Muscle-Invasive Bladder Cancer: Results from the TOMBOLA Trial
Researchers in Denmark tested a new “liquid biopsy” approach to help decide who should get immunotherapy after surgery for muscle‑invasive bladder cancer. Instead of relying only on tumour stage and PD‑L1 tests, they repeatedly checked patients’ blood for tiny fragments of tumour DNA (circulating tumour DNA, or ctDNA), which signal that cancer cells may still be present even when scans look clear. In this TOMBOLA trial, 178 patients received standard chemotherapy followed by bladder removal, then were monitored with personalized ctDNA blood tests. Patients who became ctDNA‑positive were offered up to one year of the immunotherapy drug atezolizumab, while ctDNA‑negative patients were simply followed and only treated if cancer later appeared on scans. About 6 in 10 ctDNA‑positive patients who received immunotherapy cleared the tumour DNA from their blood and had no visible cancer on imaging. Importantly, patients who stayed ctDNA‑negative after surgery had excellent outcomes, with 97% free of recurrence at one year, even though many would normally be labeled “high‑risk” and offered adjuvant immunotherapy under current guidelines. In contrast, ctDNA‑positive patients had a higher risk of relapse, but many appeared to benefit from starting immunotherapy early, before cancer was visible on scans. The treatment was generally well tolerated, and no new safety issues were seen. Overall, this study suggests that a simple blood test could more precisely show who truly needs immunotherapy after bladder removal and who can safely avoid it, reducing overtreatment and side effects while still catching recurrence early.
Note: This summary was based on research and findings from the following published paper in Annals of Oncology by Dyrskjøt, L., et al (Jan 2026; https://www.sciencedirect.com/science/article/pii/S0923753426000116?via=ihub)
FDA approves durvalumab for muscle-invasive bladder cancer: a new standard in neoadjuvant and adjuvant therapy
New findings from a large international clinical trial (Phase III NIAGARA trial) mark an important advance in the treatment of muscle-invasive bladder cancer, a form of the disease that carries a high risk of recurrence even after surgery. The study evaluated durvalumab, an immunotherapy that helps the immune system recognize and attack cancer cells, when used together with standard chemotherapy before surgery and continued after surgery. Patients who received this combined approach experienced a significant reduction in the risk of cancer returning or progressing, as well as improved overall survival, compared with those who received chemotherapy alone. Notably, many patients benefited from longer periods without disease recurrence, suggesting that strengthening the immune response early may help control bladder cancer more effectively over time. The treatment was generally well tolerated, with side effects consistent with those already seen for chemotherapy and immunotherapy. While access and reimbursement decisions may differ across countries, including Canada, these results represent a meaningful step forward and reinforce the growing role of immunotherapy in improving long-term outcomes for people living with bladder cancer.
Note: This summary was based on research and findings from the FDA page: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer
Proteomic profiling identifies muscle-invasive bladder cancers with distinct biology and responses to platinum-based chemotherapy
Scientists from the University of British Columbia have published novel research that uses protein profiling to better understand how muscle‑invasive bladder cancer (MIBC) responds to chemotherapy treatment. The research team analyzed protein patterns in tumor samples from 107 patients with MIBC who received neoadjuvant chemotherapy (treatment given before surgery). Using advanced mass spectrometry techniques, they identified four distinct protein‑based groups of bladder cancer, each with different biological characteristics and treatment responses. The study revealed that patients’ tumor protein profiles could help predict how well they might respond to standard platinum‑based chemotherapy. Additionally, by comparing tissue samples before and after treatment, researchers identified proteins that may contribute to chemotherapy resistance. Importantly, the research also found that tumors with high intra‑tumor protein variation were associated with worse patient outcomes, suggesting that protein diversity within individual tumors may influence treatment success. While this research represents an important step toward personalized bladder cancer treatment, the findings are still investigational. The protein signatures identified need validation in larger patient groups before they can guide clinical decision‑making. The study provides a foundation for developing protein‑based tests that could eventually help doctors select the most appropriate treatments for individual patients with muscle‑invasive bladder cancer.
Note: This summary was based on research and findings from the following published paper in Nature Communications by Contreras-Sanzet A et al., (Feb 2025; https://www.nature.com/articles/s41467-024-55665-1)