A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
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ClinicalTrials.gov Identifier: NCT02928406 |
Recruitment Status :
Completed
First Posted : October 10, 2016
Last Update Posted : December 22, 2022
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Condition or disease | Intervention/treatment | Phase |
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Urinary Tract Cancer | Drug: Atezolizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1005 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract |
Actual Study Start Date : | November 30, 2016 |
Actual Primary Completion Date : | December 12, 2022 |
Actual Study Completion Date : | December 12, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Atezolizumab
Participants will receive atezolizumab every 3 weeks (Q3W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
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Drug: Atezolizumab
Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.
Other Name: MPDL3280A |
- Percentage of Participants With Adverse Events [ Time Frame: Baseline up to end of study (up to approximately 6 years) ]
- Overall Survival (OS) [ Time Frame: Randomization until death from any cause (up to approximately 6 years) ]
- Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1 [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- Percentage of Participants With Best Overall Response as Assessed by Modified RECIST [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- Percentage of Participants With Disease Control as Assessed by RECIST v1.1 [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- Percentage of Participants With Disease Control as Assessed by Modified RECIST [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- Duration of Response as Assessed by RECIST v1.1 [ Time Frame: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- Duration of Response as Assessed by Modified RECIST [ Time Frame: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
- Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score [ Time Frame: Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days) ]
- Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score [ Time Frame: Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
- Participants with measurable and/or non-measurable disease according to RECIST v1.1
- Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted
- Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
Exclusion Criteria:
- Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
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Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation
- Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible
- Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible
- Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
- Significant renal disorder indicating a need for renal transplant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928406

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02928406 |
Other Study ID Numbers: |
MO29983 2016-002625-11 ( EudraCT Number ) |
First Posted: | October 10, 2016 Key Record Dates |
Last Update Posted: | December 22, 2022 |
Last Verified: | December 2022 |
Urologic Neoplasms Neoplasms Urogenital Neoplasms Neoplasms by Site Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Urologic Diseases Atezolizumab Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents |