Trial · NCT02928406
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
NCT02928406, Phase 3, Completed, Hoffmann-La Roche; results first posted 2024-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract. Trials, record NCT02928406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02928406
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
- NCT number
- NCT02928406
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,004 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Urinary Tract Cancer
- Interventions
- Atezolizumab
- First posted
- 2016-10-10
- Last updated
- 2024-04-04
- Other registries' IDs
- eudract:2016-002625-11
- Results first posted
- 2024-04-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) | Baseline up to end of study (up to approximately 6 years) | AEs were defined as any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs. |
| Secondary | Overall Survival (OS) | Randomization until death from any cause (up to approximately 6 years) | OS was defined as date of death (due to any cause) or censoring minus date of start of study treatment plus 1. |
| Secondary | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | PFS was defined as the date of first occurrence of tumor progression (earliest of the dates of the RECIST component indicating tumor progression) or date of death (in the absence of tumor progression) by any cause, whichever occurred first, or date of censoring minus date of start of study treatment plus 1. |
| Secondary | PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | PFS as per Modified RECIST was defined as: * date of first occurrence of tumor progression after a modified confirmed response if the participant was a responder according to modified RECIST or * date of first occurrence of tumor progression in case the participant was not a responder according to modified RECIST or * date of death (in the absence of tumor progression) by any cause, or * date of censoring whichever occurred first, minus date of start of study treatment plus 1 |
| Secondary | Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1 | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | BOR was assessed by the investigators according to the RECIST v1.1. BOR was defined as a complete response (CR) or partial response (PR) determined on two consecutive investigator assessments \>= 4 weeks apart in participants with measurable disease at baseline. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 millimeters (mm); PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. |
| Secondary | Percentage of Participants With BOR as Assessed by Modified RECIST | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | BOR was assessed by the investigators according to the modified RECIST. BOR was defined as complete response (CR) or partial response (PR). CR includes complete disappearance of all tumor lesions and no new measurable or unmeasurable lesions confirmed by a consecutive assessment \>=4 weeks from the first documented date. PR is a decrease in the sum of the diameters of all target and all new measurable lesions \>=30%, relative to baseline, in the absence of CR confirmed by a consecutive assessment \>=4 weeks from the first documented date. The assessment of BOR included post-screening RECIST assessments obtained up to: 1) death from any cause, 2) last evaluable RECIST assessment in the absence of death, 3) start of a subsequent anti-cancer therapy, whichever occurred first. |
| Secondary | Percentage of Participants With Disease Control as Assessed by RECIST v1.1 | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | Disease control was determined separately on disease status using RECIST v1.1 by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates. |
| Secondary | Percentage of Participants With Disease Control as Assessed by Modified RECIST | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | Disease control was determined separately on disease status using modified RECIST by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates. |
| Secondary | Duration of Response (DOR) as Assessed by RECIST v1.1 | Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | Duration of response was determined separately on disease status using RECIST v1.1 by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression or death from any cause, or to censoring date: 1) end of response coincided with the date of tumor progression or death (in the absence of tumor progression) used for the PFS endpoint, 2) for a participant without disease progression or death following a response, the censored end of response coincided with the PFS censoring date (that was latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first). |
| Secondary | DOR as Assessed by Modified RECIST | Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | Duration of response was determined separately on disease status using modified RECIST by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression following that confirmed response or death from any cause, or to censoring date: 1) end of response was the date of tumor progression after that confirmed response or death (in the absence of tumor progression), 2) for a participant without disease progression or death following a response, the censored end of response was the latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events (AEs) | Baseline up to end of study (up to approximately 6 years) | The safety population included all enrolled participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Randomization until death from any cause (up to approximately 6 years) | The intent-to-treat (ITT) population included all enrolled participants. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. | Months | MEDIAN |
| SECONDARY | PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1 | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With BOR as Assessed by Modified RECIST | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control as Assessed by RECIST v1.1 | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control as Assessed by Modified RECIST | Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by RECIST v1.1 | Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. Only participants with a response were analyzed for this outcome measure. | Months | MEDIAN |
| SECONDARY | DOR as Assessed by Modified RECIST | Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years) | The ITT population included all enrolled participants. Only participants with a response were analyzed for this outcome measure. | Months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group598
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Atezolizumab | 900 | Participants | ||
| Overall Survival (OS) | Atezolizumab | 8.57 | 95% Confidence Interval 7.75 to 9.72 | Months | |
| Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Atezolizumab | 2.20 | 95% Confidence Interval 2.14 to 2.40 | Months | |
| PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) | Atezolizumab | 2.79 | 95% Confidence Interval 2.37 to 3.45 | Months | |
| Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1 | Atezolizumab | 15.7 | 95% Confidence Interval 13.5 to 18.1 | Percentage of participants | |
| Percentage of Participants With BOR as Assessed by Modified RECIST | Atezolizumab | 16.4 | 95% Confidence Interval 14.2 to 18.9 | Percentage of participants | |
| Percentage of Participants With Disease Control as Assessed by RECIST v1.1 | Atezolizumab | 39.9 | 95% Confidence Interval 36.9 to 43.0 | Percentage of participants | |
| Percentage of Participants With Disease Control as Assessed by Modified RECIST | Atezolizumab | 46.0 | 95% Confidence Interval 42.9 to 49.2 | Percentage of participants | |
| Duration of Response (DOR) as Assessed by RECIST v1.1 | Atezolizumab | 27.79 | 95% Confidence Interval 18.89 to 43.30 | Months | |
| DOR as Assessed by Modified RECIST | Atezolizumab | 29.73 | 95% Confidence Interval 21.72 to 43.30 | Months |
1 to 10 of 598Source ClinicalTrials.gov
See all 598 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atezolizumab | 1,004 | |
| Overall Study | Did Not Receive Study Drug | Atezolizumab | 7 | |
| Overall Study | COMPLETED | Atezolizumab | 0 | |
| Overall Study | NOT COMPLETED | Atezolizumab | 1,004 |
Source ClinicalTrials.gov
Adverse events265
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | Atezolizumab | 211 | 997 | |
| other | Fatigue | General disorders | Atezolizumab | 206 | 997 | |
| other | Pyrexia | General disorders | Atezolizumab | 156 | 997 | |
| other | Oedema peripheral | General disorders | Atezolizumab | 64 | 997 | |
| other | Diarrhoea | Gastrointestinal disorders | Atezolizumab | 166 | 997 | |
| other | Constipation | Gastrointestinal disorders | Atezolizumab | 145 | 997 | |
| other | Nausea | Gastrointestinal disorders | Atezolizumab | 130 | 997 | |
| other | Vomiting | Gastrointestinal disorders | Atezolizumab | 103 | 997 | |
| other | Abdominal pain | Gastrointestinal disorders | Atezolizumab | 62 | 997 | |
| other | Urinary tract infection | Infections and infestations | Atezolizumab | 152 | 997 |
1 to 10 of 265Source ClinicalTrials.gov
See all 265 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atezolizumab | 780 | 1,004 |
| Total, other adverse events | Atezolizumab | 888 | 997 |
| Total, serious adverse events | Atezolizumab | 380 | 997 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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