ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
In the randomized, phase 3 AMBASSADOR trial, adjuvant pembrolizumab after radical surgery significantly extended disease-free survival compared with observation alone in patients with high-risk muscle-invasive or locally advanced urothelial carcinoma.…
✓ Primary source cited
Last reviewed
Clinical Trials
Important: Eligibility and enrollment are not guaranteed, and listing here is not a treatment recommendation. Talk to your care team.
Participants age 18 Years and older with Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8 who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-23
Regulatory status by jurisdiction
Country or region not specified
Status
Investigational
Last verified
2026-10-23
Cancer-type scope for this record is not yet recorded.
Participants age 18 Years and older with Intermediate Risk Non-Muscle Invasive Bladder Cancer who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-21
Regulatory status by jurisdiction
Country or region not specified
Status
Investigational
Last verified
2026-10-21
Cancer-type scope for this record is not yet recorded.
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Adults with muscle-invasive bladder cancer (MIBC) who had radical cystectomy with lymph node dissection and had detectable circulating tumor DNA (ctDNA) molecular residual disease (MRD) on serial blood testing within 12 months of surgery, randomized to atezolizumab or placebo, in the randomized, double-blind, phase 3 IMvigor011 trial.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease, as determined by an FDA-authorized test.
Biomarker requirement
Circulating tumor DNA (ctDNA) molecular residual disease, as determined by Signatera CDx
Adjuvant Atezolizumab Guided by Circulating Tumor DNA in Muscle-Invasive Bladder Cancer (New England Journal of Medicine). DOI 10.1056/NEJMoa2511885, PMID 41124204.
CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.