18 and older, any sex, with Recurrent Bladder Urothelial Carcinoma or Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete Response (CR) Rate in the Subset of Patients With Carcinoma in Situ (CIS)Primary· At 25 weeks
To estimate complete response at 25 weeks after registration for those with a CIS component. Complete Response (CR) is defined as negative biopsy for high grade disease at Week 25 (± 7 days) for the subset of patients with a CIS component at study entry, according to local pathology call. In addition, patients with a CIS component who undergo negative biopsy at Week 13 for suspicious cystoscopy and or positive cytology and have cystoscopy not suspicious for cancer and cytology not positive for malignant cells at Week 25 do not require repeat biopsy at Week 25 and will be considered to have a c
Group
Value
95% CI
Atezolizumab - CIS +/ Ta/T1
27
17 – 38
Event-free Survival (EFS) in the Ta/T1 SubsetSecondary· 18 months
To evaluate event-free survival at 18 months in the subset of participants with papillary cancer (Ta/T1) treated with atezolizumab. Event-Free Survival is defined as time from date of registration to first documentation of event. Participants last known to be alive and not to have recurred are censored at the date of last contact. An event was defined as the first occurrence of any of the following: biopsy-proven high-grade bladder cancer (including persistent CIS at 3 and/or 6 months); high-grade upper tract urothelial carcinoma; high-grade urothelial carcinoma of the prostatic urethra; muscl
To evaluate progression-free survival at 18 months in all eligible and evaluable participants. Progression-free survival (PFS) is defined as the time from registration to first evidence of biopsy-proven muscle-invasive bladder cancer (T\>=2), nodal or distant metastasis, or death from any cause. Participants without an event were censored at the date of their last cystoscopy. Estimated using Kaplan-Meier.
Group
Value
95% CI
Atezolizumab
82
74 – 88
Time to CystectomySecondary· Up to 5 years
Time to cystectomy is defined as time from discontinuation of protocol therapy to time of cystectomy.
Group
Value
95% CI
Atezolizumab
106
33 – 1233
Bladder Cancer-Specific SurvivalSecondary· 3 years
To evaluate bladder cancer-specific survival at 3 years in all eligible and evaluable participants. Bladder cancer-specific survival is defined as the time from registration to death due to bladder cancer. Participants without bladder cancer death are censored at last contact date or date of non-bladder cancer death. Estimated using Kaplan-Meier.
Group
Value
95% CI
Atezolizumab
91
83 – 95
Three-Year Overall SurvivalSecondary· 3 years
Overall survival (OS) is defined as the time from registration to the date of death due to any cause. Participants last known to be alive are censored at the date of last contact.
Group
Value
95% CI
Atezolizumab - CIS +/ Ta/T1
80
70 – 90
Atezolizumab - Ta/T1 (Without CIS)
79
68 – 91
Adverse events — posted to ClinicalTrials.gov
Time frame: Duration of treatment and follow-up until death or 5 years after registration.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Atezolizumab
Serious: 42/166 (25%)
Deaths: 25/166
Serious adverse events (73 terms)
Reaction
System
Atezolizumab
Hematuria
Renal and urinary disorders
—
Acute kidney injury
Renal and urinary disorders
—
Hyperthyroidism
Endocrine disorders
—
Urinary tract infection
Infections and infestations
—
Alanine aminotransferase increased
Investigations
—
Creatinine increased
Investigations
—
Hyponatremia
Metabolism and nutrition disorders
—
Anemia
Blood and lymphatic system disorders
—
Nausea
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Aspartate aminotransferase increased
Investigations
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Colitis
Gastrointestinal disorders
—
Diarrhea
Gastrointestinal disorders
—
Chills
General disorders
—
Edema limbs
General disorders
—
Fatigue
General disorders
—
Fever
General disorders
—
Fall
Injury, poisoning and procedural complications
—
Dehydration
Metabolism and nutrition disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
Musculoskeletal and connective tiss disorder - Other
Musculoskeletal and connective tissue disorders
—
Nervous system disorders-Other
Nervous system disorders
—
Renal and urinary disorders-Other
Renal and urinary disorders
—
Urinary retention
Renal and urinary disorders
—
Other adverse events (56 terms — click to expand)
Reaction
System
Atezolizumab
Fatigue
General disorders
—
Diarrhea
Gastrointestinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
Cough
Respiratory, thoracic and mediastinal disorders
—
Aspartate aminotransferase increased
Investigations
—
Creatinine increased
Investigations
—
Hypertension
Vascular disorders
—
Hyponatremia
Metabolism and nutrition disorders
—
Pruritus
Skin and subcutaneous tissue disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Constipation
Gastrointestinal disorders
—
Alanine aminotransferase increased
Investigations
—
Headache
Nervous system disorders
—
Skin and subcutaneous tissue disorders - Other
Skin and subcutaneous tissue disorders
—
Nausea
Gastrointestinal disorders
—
Back pain
Musculoskeletal and connective tissue disorders
—
Rash maculo-papular
Skin and subcutaneous tissue disorders
—
Urinary tract infection
Infections and infestations
—
Alkaline phosphatase increased
Investigations
—
Anorexia
Metabolism and nutrition disorders
—
Hematuria
Renal and urinary disorders
—
Lymphocyte count decreased
Investigations
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
Hypoalbuminemia
Metabolism and nutrition disorders
—
Hypothyroidism
Endocrine disorders
—
Fever
General disorders
—
Pain
General disorders
—
Urinary frequency
Renal and urinary disorders
—
Platelet count decreased
Investigations
—
White blood cell decreased
Investigations
—
Myalgia
Musculoskeletal and connective tissue disorders
—
Nasal congestion
Respiratory, thoracic and mediastinal disorders
—
Dry skin
Skin and subcutaneous tissue disorders
—
Abdominal pain
Gastrointestinal disorders
—
Edema limbs
General disorders
—
Hyperkalemia
Metabolism and nutrition disorders
—
General disorders and admin site conditions - Other
This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back (recurrent) and has not responded to treatment (refractory) with Bacillus Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
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· Phase 2
· not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec
· Phase 3
· not yet recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit
· Phase 1, PHASE2
· recruiting
Other recruiting trials for Recurrent Bladder Urothelial Carcinoma
Currently open trials in the same condition.
NCT04963153 — Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy an
· Phase 1
· active not recruiting
NCT04953104 — ARID1A and/or KDM6A Mutation and CXCL13 Expression
· Phase 2
· active not recruiting
NCT03237780 — Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothe
· Phase 2
· active not recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem
· Phase 1, PHASE2
· recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After
· Phase 1
· not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 22 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02844816.