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NCT02951767 · ClinicalTrials.gov registry record · Phase 2
A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)
A Phase 2 study of Bladder Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT02951767: Completed Phase 2 study of Bladder Cancer, sponsored by Hoffmann-La Roche.
NCT02951767 is a Phase 2 study of Bladder Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 119 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02951767, a Phase 2 study of Bladder Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.
Primary Outcome
Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be co
Conditions Studied
Interventions
- DRUG Atezolizumab
Study Locations (20)
California
- UCLA - Los Angeles
- The Angeles Clinic and Research Institute - W LA Office - Los Angeles
- USC Norris Cancer Center - Los Angeles
- UCSF - San Francisco
- Kaiser Permanente - San Marcos - San Marcos
- Stanford Cancer Center - Stanford
- Kaiser Permanente; Oncology Clinical Trials - Vallejo
Arizona
- Pinnacle Oncology Hematology - Scottsdale
- Arizona Oncology - HOPE Wilmot - Tucson
Colorado
- Rocky Mountain Cancer Center - Aurora - Aurora
- University Of Colorado - Aurora
Connecticut
- University of Connecticut Health Center - Farmington
- Yale Cancer Center ; Medical Oncology - New Haven
Illinois
- University of Chicago; Hematology/Oncology - Chicago
- Ingalls Memorial Hospital - Harvey
Alabama
- University of Alabama At Birmingham - Birmingham
District of Columbia
- Georgetown University Medical Center Lombardi Cancer Center - Washington D.C.
Florida
- Mayo Clinic Cancer Center - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2014-05-31 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 2 |
What the finished NCT02951767 record still lists
NCT02951767 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Atezolizumab is the first listed.
NCT02951767 names 20 study sites across 10 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT02951767 about?
NCT02951767 is a clinical study titled "A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)". This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve...
What is the current status of trial NCT02951767?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2014-05-31. Estimated completion is 2023-02-28.
What conditions does trial NCT02951767 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT02951767?
The interventions under investigation include: Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT02951767?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02951767 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02951767's enrollment target sits among peer trials
119 79th of 175 higher than 97 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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