The Phase 3 KEYNOTE-866 study (NCT03924856) investigating perioperative pembrolizumab combined with neoadjuvant chemotherapy for cisplatin-eligible muscle-invasive bladder cancer completed its primary data collection on 2026-01-26. This milestone indicates the completion of the main data collection period for the trial, moving it closer to potential data analysis and reporting.
Background
Pembrolizumab (Keytruda) is an established immunotherapy. This trial focuses on its use in bladder cancer, specifically cisplatin-eligible muscle-invasive bladder cancer (MIBC).
Trial design
The KEYNOTE-866 study (NCT03924856) is a Phase 3, global, randomized trial that enrolled 907 participants. The study is evaluating perioperative pembrolizumab plus neoadjuvant chemotherapy compared to perioperative placebo plus neoadjuvant chemotherapy in patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC). The interventions involved pembrolizumab, gemcitabine, cisplatin, and placebo arms. The trial's objective is to assess the efficacy of pembrolizumab in this perioperative setting.
What this means
The primary completion of the KEYNOTE-866 study signifies a critical step towards understanding the potential role of perioperative pembrolizumab in treating cisplatin-eligible muscle-invasive bladder cancer. Clinicians and researchers will await the full results of this Phase 3 trial to evaluate its efficacy and safety profile in this specific patient population. The findings could potentially inform future treatment strategies for bladder cancer.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT03924856, titled 'Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866),' was posted on 2026-01-26 on clinicaltrials.gov.