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Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer

Study acronym: AMBASSADOR
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 8, 2026 → Oct 31, 2026
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 664 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (914)
  2. Study sites revised (914)v663 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 915 to 914v662
  4. Primary and study completion pushed from Aug 8, 2026 to Oct 31, 2026v661
  5. Study sites revised (915)v660 See this version in full on ClinicalTrials.gov ↗
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites revised (915)v659 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (915)v658 See this version in full on ClinicalTrials.gov ↗
  1. Primary and study completion pushed from Jun 1, 2026 to Aug 8, 2026 Study sites: 916 to 915v657 Show 1 more changeShow less
    • Study sites: 916 to 915
  2. Primary and study completion dates: Jun 1, 2026 to Aug 8, 2026v656
  3. Study sites revised (916)v655 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv654
  5. Study sites: 917 to 916v653
  6. 38 versions Re-verified since Feb 17, 2026, no change to tracked fieldsv615-v652
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.
Trial Details
NCT Number NCT03244384
Lead Sponsor National Cancer Institute (NCI)
Conditions Localized Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage II Renal Pelvis and Ureter Cancer AJCC v7, Stage II Ureter Cancer AJCC v7 +3 more
Enrollment 739 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov