What the trial was testing
The JAVELIN BLADDER 100 enrolled 700 patients with bladder cancer. The study was sponsored by Pfizer and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. 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
Patients who continued avelumab after chemotherapy lived 7 months longer on average.
The New England journal of medicine · 2020 · NCT02603432
These findings — that patients lived 7 months longer when continuing avelumab versus stopping treatment after chemotherapy — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 700 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
Avelumab is FDA-approved as maintenance therapy for advanced bladder cancer that hasn't grown after initial chemotherapy. If you've completed first-line chemotherapy for metastatic bladder cancer and your disease is stable, ask your oncologist whether continuing with avelumab maintenance is right for you.
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
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy