Trial · NCT02807636
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
NCT02807636, Phase 3, Completed, Hoffmann-La Roche; results first posted 2023-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma. Trials, record NCT02807636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02807636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
- NCT number
- NCT02807636
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,213 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Urothelial Carcinoma
- Interventions
- Atezolizumab, Carboplatin, Gemcitabine, Placebo, Cisplatin
- First posted
- 2016-06-21
- Last updated
- 2025-02-24
- Other registries' IDs
- eudract:2016-000250-35
- Results first posted
- 2023-12-13
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm | Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months) | PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first. |
| Primary | Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline until death due to any cause (up to approximately 73 months) | OS is defined as the time from randomization to death due to any cause. |
| Primary | Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline until death due to any cause (up to approximately 73 months) | OS is defined as the time from randomization to death due to any cause. |
| Secondary | Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline. |
| Secondary | Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline. |
| Secondary | Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first. |
| Secondary | Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first. |
| Secondary | IRF-PFS | Randomization to first documented disease progression or death from any cause (up to 35 months) | Independent review facility PFS (IRF-PFS) is defined as the time from randomization to the first documented disease progression as determined by blinded independent central review with use of RECIST v1.1, or death due to any cause, whichever occurs first. |
| Secondary | OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Year 1 | Overall Survival (OS) Event Free Rate at 1 Year. |
| Secondary | OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Year 1 | Overall Survival (OS) Event Free Rate at 1 Year. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm | Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months) | The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline until death due to any cause (up to approximately 73 months) | The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline until death due to any cause (up to approximately 73 months) | The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment. | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | The duration of response (DOR)-evaluable population is defined as participants with an objective response in the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2. | Months | NUMBER |
| SECONDARY | Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months) | The duration of response (DOR)-evaluable population is defined as participants with an objective response in the the ITT population which included only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. | Months | NUMBER |
| SECONDARY | IRF-PFS | Randomization to first documented disease progression or death from any cause (up to 35 months) | The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. | Months | NUMBER |
| SECONDARY | OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Year 1 | The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. | Percentage | NUMBER |
| SECONDARY | OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Year 1 | The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. | Percentage | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm | Placebo+Gemcitabine+Carboplatin/Cisplatin | 6.34 | 95% Confidence Interval 6.24 to 7.00 | Months | |
| Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 8.18 | 95% Confidence Interval 6.51 to 8.34 | Months | |
| Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Placebo+Gemcitabine+Carboplatin/Cisplatin | 13.44 | 95% Confidence Interval 11.99 to 15.34 | Months | |
| Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 16.13 | 95% Confidence Interval 14.19 to 18.76 | Months | |
| Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Placebo+Gemcitabine+Carboplatin/Cisplatin | 13.34 | 95% Confidence Interval 11.89 to 15.61 | Months | |
| Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Atezolizumab Monotherapy | 15.21 | 95% Confidence Interval 13.14 to 17.68 | Months | |
| Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Placebo+Gemcitabine+Carboplatin/Cisplatin | 44.8 | 95% Confidence Interval 39.87 to 49.88 | Percentage of Participants | |
| Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 48.1 | 95% Confidence Interval 43.38 to 52.84 | Percentage of Participants | |
| Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Placebo+Gemcitabine+Carboplatin/Cisplatin | 44.4 | 95% Confidence Interval 39.15 to 49.71 | Percentage of Participants | |
| Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm | Atezolizumab Monotherapy | 24.2 | 95% Confidence Interval 19.89 to 29.01 | Percentage of Participants |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo+Gemcitabine+Carboplatin/Cisplatin | 400 | |
| Overall Study | STARTED | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 451 | |
| Overall Study | STARTED | Atezolizumab Monotherapy | 362 | |
| Overall Study | COMPLETED | Placebo+Gemcitabine+Carboplatin/Cisplatin | 0 | |
| Overall Study | COMPLETED | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 0 | |
| Overall Study | COMPLETED | Atezolizumab Monotherapy | 0 | |
| Overall Study | NOT COMPLETED | Placebo+Gemcitabine+Carboplatin/Cisplatin | 400 | |
| Overall Study | NOT COMPLETED | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 451 | |
| Overall Study | NOT COMPLETED | Atezolizumab Monotherapy | 362 |
Source ClinicalTrials.gov
Adverse events1,065
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 | Placebo+Gemcitabine+Carboplatin/Cisplatin | 257 | 389 | 481 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 308 | 454 | 495 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab Monotherapy | 68 | 354 | 83 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo+Gemcitabine+Carboplatin/Cisplatin | 64 | 389 | 192 |
| other | Leukopenia | Blood and lymphatic system disorders | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 64 | 454 | 132 |
| other | Leukopenia | Blood and lymphatic system disorders | Atezolizumab Monotherapy | 0 | 354 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo+Gemcitabine+Carboplatin/Cisplatin | 148 | 389 | 421 |
| other | Neutropenia | Blood and lymphatic system disorders | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 215 | 454 | 510 |
| other | Neutropenia | Blood and lymphatic system disorders | Atezolizumab Monotherapy | 2 | 354 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo+Gemcitabine+Carboplatin/Cisplatin | 117 | 389 | 297 |
1 to 10 of 1,065Source ClinicalTrials.gov
See all 1,065 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo+Gemcitabine+Carboplatin/Cisplatin | 303 | 389 |
| Total, all-cause mortality | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 332 | 454 |
| Total, all-cause mortality | Atezolizumab Monotherapy | 272 | 354 |
| Total, other adverse events | Placebo+Gemcitabine+Carboplatin/Cisplatin | 379 | 389 |
| Total, other adverse events | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 441 | 454 |
| Total, other adverse events | Atezolizumab Monotherapy | 300 | 354 |
| Total, serious adverse events | Placebo+Gemcitabine+Carboplatin/Cisplatin | 197 | 389 |
| Total, serious adverse events | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | 244 | 454 |
| Total, serious adverse events | Atezolizumab Monotherapy | 163 | 354 |
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.
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