What the trial was testing
The SUNRISE-4 enrolled 163 patients with bladder cancer. The study was sponsored by Janssen Research & Development, LLC and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
42% of patients had no cancer remaining in their bladder after the combination treatment.
The Lancet. Oncology · 2025 · NCT04919512
These findings — that patients with muscle-invasive bladder cancer had no remaining cancer after combination treatment before surgery — were published in the The Lancet. Oncology and represent the headline result of the study.
Researchers tracked outcomes across 163 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with bladder cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
If you have muscle-invasive bladder cancer and can't get standard chemo before surgery, this combination might help shrink or clear your tumor. This was a mid-stage study and these treatments are not yet FDA-approved for this use. Talk to your oncologist about whether similar clinical trials are open or if these drugs are available as off-label options.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open bladder cancer trials
Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer
A multi-center, open-label, phase II clinical study of metformin in up to evaluable 49 patients with low-grade NMIBC with the aim to determine the overall response to administration of oral metformin for 3 months in a index papillary NMIBC tumour.
Bladder Cancer Longitudinal Biorepository for Development of Novel Therapeutics/Biomarkers
The purpose of this study is to create a registry, which is a "bank" of information about patients who have had similar medical conditions and treatments. The registry will be used by researchers to learn more about long term outcome of patients with bladder cancer, how bladder cancer tissues are related to tumor development, recurrence and survival.