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
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.