Trial · NCT02450331
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
NCT02450331, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2020-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection. Trials, record NCT02450331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02450331
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
- NCT number
- NCT02450331
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 809 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Carcinoma, Transitional Cell
- Interventions
- Atezolizumab
- First posted
- 2015-05-21
- Last updated
- 2023-06-18
- Other registries' IDs
- eudract:2014-005603-25
- Results first posted
- 2020-11-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-Free Survival (DFS), as Assessed by Investigator | Randomization up to first occurrence of DFS event (up to approximately 50 months) | DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations. |
| Secondary | Overall Survival (OS) | Randomization until death due to any cause (up to approximately 80 months) | Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation. |
| Secondary | Disease-Specific Survival (DSS), as Assessed by Investigator | Randomization until death due to UC (up to approximately 50 months) | DSS is defined as the time from randomization until the date of death from UC. |
| Secondary | Distant Metastasis-Free Survival (DMFS) | Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months) | DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations. |
| Secondary | Non-Urinary Tract Recurrence-Free Survival (NURFS) | Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months) | NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Screening up to approximately 80 months | Percentage of participants with at least one Adverse Event. |
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Baseline up to approximately 50 months | Percentage of participants with anti-therapeutic antibodies to atezolizumab. |
| Secondary | EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score | Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days) | The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state." |
| Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days) | Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab. |
| Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Day 1 of Cycle 1 (Cycle length = 21 days) | Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-Free Survival (DFS), as Assessed by Investigator | Randomization up to first occurrence of DFS event (up to approximately 50 months) | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization until death due to any cause (up to approximately 80 months) | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Months | MEDIAN |
| SECONDARY | Disease-Specific Survival (DSS), as Assessed by Investigator | Randomization until death due to UC (up to approximately 50 months) | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Months | MEDIAN |
| SECONDARY | Distant Metastasis-Free Survival (DMFS) | Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months) | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Months | MEDIAN |
| SECONDARY | Non-Urinary Tract Recurrence-Free Survival (NURFS) | Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months) | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Screening up to approximately 80 months | The safety population is defined as patients who received at least one dose of atezolizumab, and all patients who did not receive any dose of atezolizumab who had at least one post-baseline safety assessment (e.g.,adverse event, lab, vital signs, ECG, etc.), regardless of their assigned treatment (atezolizumab/observation). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Baseline up to approximately 50 months | The anti-drug antibodies (ADA)-evaluable population is defined as all patients treated with atezolizumab who have at least one post-baseline ADA result. | Percentage of Participants | NUMBER |
| SECONDARY | EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score | Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days) | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Score on scale | MEAN |
| SECONDARY | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days) | The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples. | µg/mL | MEAN |
| SECONDARY | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Day 1 of Cycle 1 (Cycle length = 21 days) | The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples. | µg/mL | MEAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-Free Survival (DFS), as Assessed by Investigator | Observation | 16.6 | 95% Confidence Interval 11.2 to 24.8 | Months | |
| Disease-Free Survival (DFS), as Assessed by Investigator | Atezolizumab | 19.4 | 95% Confidence Interval 15.9 to 24.8 | Months | |
| Overall Survival (OS) | Observation | 59.0 | 95% Confidence Interval 47.7 to NA | Months | |
| Overall Survival (OS) | Atezolizumab | 61.4 | 95% Confidence Interval 47.0 to NA | Months | |
| Disease-Specific Survival (DSS), as Assessed by Investigator | Observation | NA | 95% Confidence Interval NA to NA | Months | |
| Disease-Specific Survival (DSS), as Assessed by Investigator | Atezolizumab | NA | 95% Confidence Interval NA to NA | Months | |
| Distant Metastasis-Free Survival (DMFS) | Observation | 31.1 | 95% Confidence Interval 21.7 to 41.4 | Months | |
| Distant Metastasis-Free Survival (DMFS) | Atezolizumab | 27.5 | 95% Confidence Interval 22.6 to NA | Months | |
| Non-Urinary Tract Recurrence-Free Survival (NURFS) | Observation | 19.5 | 95% Confidence Interval 12.3 to 27.7 | Months | |
| Non-Urinary Tract Recurrence-Free Survival (NURFS) | Atezolizumab | 22.1 | 95% Confidence Interval 17.2 to 27.6 | Months |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Observation | 403 | |
| Overall Study | STARTED | Atezolizumab | 406 | |
| Overall Study | COMPLETED | Observation | 171 | |
| Overall Study | COMPLETED | Atezolizumab | 178 | |
| Overall Study | NOT COMPLETED | Observation | 232 | |
| Overall Study | NOT COMPLETED | Atezolizumab | 228 |
Source ClinicalTrials.gov
Adverse events334
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 | OBSERVATION | 32 | 398 | 34 |
| other | Anaemia | Blood and lymphatic system disorders | ATEZOLIZUMAB | 42 | 390 | 53 |
| other | Hypothyroidism | Endocrine disorders | OBSERVATION | 0 | 398 | 0 |
| other | Hypothyroidism | Endocrine disorders | ATEZOLIZUMAB | 35 | 390 | 38 |
| other | Abdominal pain | Gastrointestinal disorders | OBSERVATION | 29 | 398 | 32 |
| other | Abdominal pain | Gastrointestinal disorders | ATEZOLIZUMAB | 31 | 390 | 39 |
| other | Constipation | Gastrointestinal disorders | OBSERVATION | 39 | 398 | 40 |
| other | Constipation | Gastrointestinal disorders | ATEZOLIZUMAB | 51 | 390 | 60 |
| other | Diarrhoea | Gastrointestinal disorders | OBSERVATION | 25 | 398 | 29 |
| other | Diarrhoea | Gastrointestinal disorders | ATEZOLIZUMAB | 81 | 390 | 104 |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OBSERVATION | 162 | 403 |
| Total, all-cause mortality | ATEZOLIZUMAB | 171 | 406 |
| Total, other adverse events | OBSERVATION | 234 | 398 |
| Total, other adverse events | ATEZOLIZUMAB | 324 | 390 |
| Total, serious adverse events | OBSERVATION | 72 | 398 |
| Total, serious adverse events | ATEZOLIZUMAB | 122 | 390 |
Source ClinicalTrials.gov
Papers5
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 |
|---|---|
| OBSERVATION vs ATEZOLIZUMAB: deaths from any cause | Trial comparisons |
| OBSERVATION 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/NCT02450331
GET https://conductscience.org/api/trials/v1/NCT02450331/results?page=2