Neoadjuvant nivolumab plus gemcitabine-cisplatin followed by postsurgical adjuvant nivolumab versus neoadjuvant gemcitabine-cisplatin in patients with muscle-invasive bladder cancer: final results from the phase III CA017-078 trial.
Checkpoint inhibitor added to bladder cancer surgery increased complete tumor removal rates, and blood tumor DNA predicted which patients faced higher recurrence risk.
Perioperative nivolumab improved pCR (39.1% vs 29.6%) but did NOT significantly improve event-free survival (HR 0.94, P=0.67) in resectable MIBC at 54.5 months median follow-up; ctDNA positivity and persistence were strongly prognostic for EFS and OS. This record was retained from the prior triage attempt for PubMed pipeline handoff.
What the study was
- Study design
- Phase 3 RCT (final analysis)
- Category
- novel_therapeutics
- Maturity
- Potentially Practice-Changing
- Journal
- Ann Oncol
Why it surfaced
Final Phase 3 results from a high-profile Ann Oncol trial reporting a negative EFS primary endpoint despite improved pCR with perioperative nivolumab in MIBC, plus novel ctDNA prognostic data; important null finding with direct implications for standard-of-care and biomarker-stratified trial design.
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