Trial · NCT02108652
A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)
NCT02108652, Phase 2, Completed, Hoffmann-La Roche; results first posted 2017-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2). Trials, record NCT02108652. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02108652
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)
- NCT number
- NCT02108652
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 310 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Bladder Cancer
- Interventions
- Atezolizumab
- First posted
- 2014-04-09
- Last updated
- 2024-03-28
- Other registries' IDs
- eudract:2013-005486-39
- Results first posted
- 2017-01-04
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | 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 confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method. |
| Primary | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. |
| Secondary | Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. 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 \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. |
| Secondary | DOR as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator 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 \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. |
| Secondary | DOR as Assessed by the Investigator According to Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. |
| Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. |
| Secondary | Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. |
| Secondary | PFS as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population included Intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 2 ITT population included all participants from Cohort 2 who received any amount of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | DOR as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | DOR as Assessed by the Investigator According to Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | months | MEDIAN |
| SECONDARY | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | percentage of participants | NUMBER |
| SECONDARY | PFS as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | months | MEDIAN |
| SECONDARY | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group22
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 a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Cohort 2: Participants With Second-line or Beyond Treatments | 15.8 | 95% Confidence Interval 11.9 to 20.4 | percentage of participants | |
| Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST | Cohort 2: Participants With Second-line or Beyond Treatments | 19.7 | 95% Confidence Interval 15.4 to 24.6 | percentage of participants | |
| Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | Cohort 2: Participants With Second-line or Beyond Treatments | NA | Full Range 2.1 to NA | months | |
| DOR as Assessed by the Investigator According to RECIST v1.1 | Cohort 2: Participants With Second-line or Beyond Treatments | 20.50 | Full Range 2.1 to 20.5 | months | |
| DOR as Assessed by the Investigator According to Modified RECIST | Cohort 2: Participants With Second-line or Beyond Treatments | 20.50 | Full Range 2.1 to 20.5 | months | |
| Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Cohort 2: Participants With Second-line or Beyond Treatments | 88.4 | percentage of participants | ||
| Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | Cohort 2: Participants With Second-line or Beyond Treatments | 2.10 | 95% Confidence Interval 2.07 to 2.14 | months | |
| Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Cohort 2: Participants With Second-line or Beyond Treatments | 89.7 | percentage of participants | ||
| PFS as Assessed by the Investigator According to RECIST v1.1 | Cohort 2: Participants With Second-line or Beyond Treatments | 2.10 | 95% Confidence Interval 2.07 to 2.14 | months | |
| Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST | Cohort 2: Participants With Second-line or Beyond Treatments | 87.1 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 2: Participants With Second-line or Beyond Treatments | 310 | |
| Overall Study | COMPLETED | Cohort 2: Participants With Second-line or Beyond Treatments | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2: Participants With Second-line or Beyond Treatments | 310 |
Source ClinicalTrials.gov
Adverse events198
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 | ANAEMIA | Blood and lymphatic system disorders | MPDL3280A COHORT2 INFUSION | 56 | 310 | 72 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | MPDL3280A COHORT2 INFUSION | 44 | 310 | 54 |
| other | CONSTIPATION | Gastrointestinal disorders | MPDL3280A COHORT2 INFUSION | 85 | 310 | 102 |
| other | DIARRHOEA | Gastrointestinal disorders | MPDL3280A COHORT2 INFUSION | 69 | 310 | 103 |
| other | DRY MOUTH | Gastrointestinal disorders | MPDL3280A COHORT2 INFUSION | 24 | 310 | 25 |
| other | NAUSEA | Gastrointestinal disorders | MPDL3280A COHORT2 INFUSION | 86 | 310 | 114 |
| other | VOMITING | Gastrointestinal disorders | MPDL3280A COHORT2 INFUSION | 61 | 310 | 83 |
| other | ASTHENIA | General disorders | MPDL3280A COHORT2 INFUSION | 23 | 310 | 37 |
| other | CHILLS | General disorders | MPDL3280A COHORT2 INFUSION | 34 | 310 | 37 |
| other | FATIGUE | General disorders | MPDL3280A COHORT2 INFUSION | 164 | 310 | 228 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MPDL3280A COHORT2 INFUSION | 253 | 310 |
| Total, other adverse events | MPDL3280A COHORT2 INFUSION | 287 | 310 |
| Total, serious adverse events | MPDL3280A COHORT2 INFUSION | 155 | 310 |
Source ClinicalTrials.gov
Papers8
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02108652
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