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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02302807




Registration number
NCT02302807
Ethics application status
Date submitted
25/11/2014
Date registered
27/11/2014
Date last updated
1/08/2019

Titles & IDs
Public title
A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Secondary ID [1] 0 0
2014-003231-19
Secondary ID [2] 0 0
GO29294
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Treatment: Drugs - Docetaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Vinflunine

Experimental: Arm A: Atezolizumab - Atezolizumab will be administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants will receive atezolizumab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Active Comparator: Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) - Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.


Treatment: Drugs: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

Treatment: Drugs: Docetaxel
Docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Treatment: Drugs: Paclitaxel
Paclitaxel 175 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Treatment: Drugs: Vinflunine
Vinflunine 320 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS was defined as time from randomization to death from any cause.
Timepoint [1] 0 0
Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
Secondary outcome [1] 0 0
Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 - 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).
Timepoint [1] 0 0
Up to approximately 25 months after first participant enrolled
Secondary outcome [2] 0 0
Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1 - 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.
Timepoint [2] 0 0
Up to approximately 25 months after first participant enrolled
Secondary outcome [3] 0 0
Percentage of Participants With Adverse Events (AEs) - 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.
Timepoint [3] 0 0
Up to approximately 46 months after first participant enrolled
Secondary outcome [4] 0 0
Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab - 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.
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin) - Cmin was measured for all participants that received at least one dose of Atezolizumab.
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
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) - 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
Timepoint [6] 0 0
Up to approximately 25 months after first participant enrolled
Secondary outcome [7] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax) - Cmax was measured for all participants that received at least one dose of Atezolizumab.
Timepoint [7] 0 0
30 minutes post dose on Day 1 of Cycles 1
Secondary outcome [8] 0 0
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 - 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.
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
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 - 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.
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale - 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.
Timepoint [10] 0 0
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)

Eligibility
Key inclusion criteria
- Histologically or cytologically documented locally advanced or metastatic UBC
(including renal pelvis, ureters, urinary bladder, and urethra).

- Representative tumor specimens as specified by the protocol

- Disease progression during or following treatment with at least one
platinum-containing regimen for inoperable, locally advanced or metastatic UBC or
disease recurrence

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Life expectancy greater than or equal to (>/=) 12 weeks

- Measurable disease, as defined by RECIST v1.1

- Adequate hematologic and end organ function

- For women of childbearing potential, agreement to refrain from heterosexual
intercourse or use contraceptive methods that result in a failure rate of < 1% per
year during the treatment period and for at least 5 months after the last dose of
atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last
dose of paclitaxel or docetaxel.

- For men, agreement to refrain from heterosexual intercourse or use contraceptive
methods that result in a failure rate of < 1% per year during the treatment period and
for at least 3 months after the last dose of vinflunine and 6 months from the last
dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to enrollment

- Active or untreated central nervous system (CNS) metastases as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and
prior radiographic assessments

- Leptomeningeal disease

- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception
of those with a negligible risk of metastasis or death and treated with expected
curative outcome, or localized prostate cancer treated with curative intent and
absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

- Pregnant and lactating women

- Significant cardiovascular disease

- Severe infections within 4 weeks prior to randomization

- Major surgical procedure other than for diagnosis within 4 weeks prior to
randomization

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy
to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the
atezolizumab formulation

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplant

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan

- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or
hepatitis C or tuberculosis

- Administration of a live, attenuated vaccine within 4 weeks prior to randomization

- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated
protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed
death-ligand 1 (anti-PD-L1) therapeutic antibodies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital; Medical Oncology - Herston
Recruitment hospital [2] 0 0
Royal Adelaide Hospital; Oncology - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre; Oncology - Clayton
Recruitment hospital [4] 0 0
Austin and Repatriation Medical Centre; Cancer Services - Melbourne
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
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United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
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Nevada
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United States of America
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North Carolina
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United States of America
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South Carolina
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United States of America
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Tennessee
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Gent
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Leuven
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Czechia
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Brno
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Czechia
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Olomouc
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Czechia
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Pardubice
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Herlev
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København Ø
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Rouen
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Düsseldorf
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Erlangen
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Freiburg
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Göttingen
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Heidelberg
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Magdeburg
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Mannheim
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München
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Tübingen
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Ulm
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Athens
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Heraklion
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Patras
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Thessaloniki
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Szolnok
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Aichi
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Aomori
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Chiba
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Ehime
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Fukuoka
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Gunma
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Hiroshima
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Hokkaido
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Ibaraki
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Iwate
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Kanagawa
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Kumamoto
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Niigata
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Osaka
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Shizuoka
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Japan
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Tokushima
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Tokyo
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Hoofddorp
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Netherlands
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Maastricht
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Netherlands
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Nieuwegein
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Netherlands
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Zwolle
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Norway
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Kristiansand
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Norway
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Tromsø
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Norway
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Trondheim
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Poland
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Bialystok
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Poland
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Gdansk
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Lublin
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Poznan
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Warszawa
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Wroclaw
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Portugal
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Lisboa
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Portugal
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Loures
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Portugal
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Porto
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Romania
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Baia Mare
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Romania
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Bucharest
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Romania
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Cluj-napoca
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Targu Mures
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Romania
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Timisoara
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Russian Federation
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Niznij Novgorod
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Russian Federation
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Barnaul
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Russian Federation
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Stavropol
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Serbia
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Belgrade
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Serbia
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Sremska Kamenica
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Slovenia
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Ljubljana
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Islas Baleares
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Spain
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LA Coruña
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Spain
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Navarra
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Spain
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Caceres
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Stockholm
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Sweden
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Umea
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Switzerland
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Bern
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Switzerland
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Chur
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Switzerland
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Geneve
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Switzerland
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St. Gallen
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Switzerland
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Zürich
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Taiwan
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Taichung
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Taiwan
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Taipei
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Turkey
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Bursa
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Malatya
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Turkey
State/province [152] 0 0
Sihhiye, Ankara
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Birmingham
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Bristol
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Cambridge
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Cheltenham
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Coventry
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Exeter
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Lancaster
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Leeds
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Leicester
Country [162] 0 0
United Kingdom
State/province [162] 0 0
London
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Newcastle Upon Tyne
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Nottingham
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Oxford
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Scunthorpe
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Southampton
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Sutton
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Truro
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study
designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in
participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have
progressed during or following a platinum-containing regimen. The anticipated time on study
treatment is based on continued clinical benefit, i.e., until disease progression or
unacceptable toxicity. The target sample size is 931 participants.
Trial website
https://clinicaltrials.gov/show/NCT02302807
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications