Trial · NCT02302807
A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
NCT02302807, Phase 3, Completed, Hoffmann-La Roche; results first posted 2018-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]. Trials, record NCT02302807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02302807
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
- NCT number
- NCT02302807
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 931 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Bladder Cancer
- Interventions
- Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Docetaxel, Paclitaxel, Vinflunine
- First posted
- 2014-11-27
- Last updated
- 2019-08-01
- Other registries' IDs
- eudract:2014-003231-19
- Results first posted
- 2018-04-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled | OS was defined as time from randomization to death from any cause. |
| Secondary | Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 | Up to approximately 25 months after first participant enrolled | PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of \>/= 5 millimeters (mm). |
| Secondary | Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1 | Up to approximately 25 months after first participant enrolled | DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Up to approximately 46 months after first participant enrolled | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Secondary | Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab | Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days) | Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was \>/= 0.60 titer units at any time after initial drug initiation. |
| Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days) | Cmin was measured for all participants that received at least one dose of Atezolizumab. |
| Secondary | Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) | Up to approximately 25 months after first participant enrolled | ORR was defined as the percentage of participants, who had an objective response. Objective response was defined as either a complete response (CR) or partial response (PR) as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Objective response in this study did not need to be a confirmed response. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. ORR=CR+PR |
| Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | 30 minutes post dose on Day 1 of Cycles 1 | Cmax was measured for all participants that received at least one dose of Atezolizumab. |
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale | Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days) | The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS. |
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale | Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days) | The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 | Up to approximately 25 months after first participant enrolled | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | months | MEDIAN |
| SECONDARY | Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1 | Up to approximately 25 months after first participant enrolled | DOR analyses was performed on the subset of patients who achieved an objective response. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Up to approximately 46 months after first participant enrolled | Safety analyses was performed on all randomized patients who received any amount of study treatment, with patients grouped according to whether any amount of atezolizumab was received including the case when atezolizumab was received in error. | percentage | NUMBER |
| SECONDARY | Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab | Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days) | ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result. | percentage of participants | NUMBER |
| SECONDARY | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days) | The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) | Up to approximately 25 months after first participant enrolled | ORR analyses was performed on all randomized patients who had measureable disease at baseline | Percentage of participants | NUMBER |
| SECONDARY | Maximum Observed Serum Atezolizumab Concentration (Cmax) | 30 minutes post dose on Day 1 of Cycles 1 | The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale | Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days) | All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment. | units of a scale | MEAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale | Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days) | All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment. | units of a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group89
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | IC2/3 Chemotherapy | 10.6 | 95% Confidence Interval 8.4 to 12.2 | Months | |
| Overall Survival (OS) | IC2/3 Atezolizumab | 11.1 | 95% Confidence Interval 8.6 to 15.5 | Months | |
| Overall Survival (OS) | IC1/2/3 Chemotherapy | 8.2 | 95% Confidence Interval 7.4 to 9.5 | Months | |
| Overall Survival (OS) | IC1/2/3 Atezolizumab | 8.9 | 95% Confidence Interval 8.2 to 10.9 | Months | |
| Overall Survival (OS) | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 8.0 | 95% Confidence Interval 7.2 to 8.6 | Months | |
| Overall Survival (OS) | Atezolizumab | 8.6 | 95% Confidence Interval 7.8 to 9.6 | Months | |
| Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 4.0 | 95% Confidence Interval 3.4 to 4.2 | months | |
| Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 | Atezolizumab | 2.1 | 95% Confidence Interval 2.1 to 2.2 | months | |
| Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 | IC2/3 Chemotherapy | 4.2 | 95% Confidence Interval 3.7 to 5.0 | months | |
| Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 | IC2/3 Atezolizumab | 2.4 | 95% Confidence Interval 2.1 to 4.2 | months |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 464 | |
| Overall Study | STARTED | Atezolizumab | 467 | |
| Overall Study | Received Treatment | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 443 | |
| Overall Study | Received Treatment | Atezolizumab | 459 | |
| Overall Study | COMPLETED | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 0 | |
| Overall Study | COMPLETED | Atezolizumab | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 464 | |
| Overall Study | NOT COMPLETED | Atezolizumab | 467 |
Source ClinicalTrials.gov
Adverse events518
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 | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 124 | 443 | 142 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab | 90 | 459 | 94 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 57 | 443 | 75 |
| other | Neutropenia | Blood and lymphatic system disorders | Atezolizumab | 5 | 459 | 6 |
| other | Abdominal Pain | Gastrointestinal disorders | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 58 | 443 | 63 |
| other | Abdominal Pain | Gastrointestinal disorders | Atezolizumab | 52 | 459 | 60 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 27 | 443 | 32 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Atezolizumab | 23 | 459 | 23 |
| other | Constipation | Gastrointestinal disorders | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 163 | 443 | 221 |
| other | Constipation | Gastrointestinal disorders | Atezolizumab | 131 | 459 | 147 |
1 to 10 of 518Source ClinicalTrials.gov
See all 518 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 393 | 443 |
| Total, all-cause mortality | Atezolizumab | 379 | 459 |
| Total, other adverse events | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 417 | 443 |
| Total, other adverse events | Atezolizumab | 413 | 459 |
| Total, serious adverse events | Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 189 | 443 |
| Total, serious adverse events | Atezolizumab | 192 | 459 |
Source ClinicalTrials.gov
Papers7
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) vs Atezolizumab: deaths from any cause | Trial comparisons |
| Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) vs Atezolizumab: serious adverse events | Trial comparisons |
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/NCT02302807
GET https://conductscience.org/api/trials/v1/NCT02302807/results?page=2