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A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02302807
Recruitment Status : Completed
First Posted : November 27, 2014
Results First Posted : April 11, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bladder Cancer
Interventions Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Drug: Docetaxel
Drug: Paclitaxel
Drug: Vinflunine
Enrollment 931
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Hide Arm/Group Description Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity. Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
Period Title: Overall Study
Started 464 467
Received Treatment 443 459
Completed 0 [1] 0 [2]
Not Completed 464 467
Reason Not Completed
Withdrawal by Subject             28             11
Lost to Follow-up             4             6
Death             397             385
Study Terminated By Sponsor             35             64
Physician Decision             0             1
[1]
Participants still on chemotherapy were discontinued where that treatment was available locally.
[2]
Participants still receiving atezolizumab had opportunity to continue treatment in extension study.
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab Total
Hide Arm/Group Description Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity. Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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. Total of all reporting groups
Overall Number of Baseline Participants 464 467 931
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 464 participants 467 participants 931 participants
66.1  (9.3) 65.9  (9.6) 66.0  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 464 participants 467 participants 931 participants
Female
103
  22.2%
110
  23.6%
213
  22.9%
Male
361
  77.8%
357
  76.4%
718
  77.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 464 participants 467 participants 931 participants
Hispanic or Latino
16
   3.4%
13
   2.8%
29
   3.1%
Not Hispanic or Latino
368
  79.3%
363
  77.7%
731
  78.5%
Unknown or Not Reported
80
  17.2%
91
  19.5%
171
  18.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 464 participants 467 participants 931 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
55
  11.9%
63
  13.5%
118
  12.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   0.4%
1
   0.2%
3
   0.3%
White
336
  72.4%
335
  71.7%
671
  72.1%
More than one race
1
   0.2%
0
   0.0%
1
   0.1%
Unknown or Not Reported
70
  15.1%
68
  14.6%
138
  14.8%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as time from randomization to death from any cause.
Time Frame Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.
Arm/Group Title IC2/3 Chemotherapy IC2/3 Atezolizumab IC1/2/3 Chemotherapy IC1/2/3 Atezolizumab Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Hide Arm/Group Description:
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
Overall Number of Participants Analyzed 118 116 309 316 464 467
Median (95% Confidence Interval)
Unit of Measure: Months
10.6
(8.4 to 12.2)
11.1
(8.6 to 15.5)
8.2
(7.4 to 9.5)
8.9
(8.2 to 10.9)
8.0
(7.2 to 8.6)
8.6
(7.8 to 9.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IC2/3 Chemotherapy, IC2/3 Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4134
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.63 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IC1/2/3 Chemotherapy, IC1/2/3 Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.71 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel), Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.73 to 0.99
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
Hide Description 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).
Time Frame Up to approximately 25 months after first participant enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab IC2/3 Chemotherapy IC2/3 Atezolizumab IC1/2/3 Chemotherapy IC1/2/3 Atezolizumab
Hide Arm/Group Description:
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
Overall Number of Participants Analyzed 464 467 118 116 309 316
Median (95% Confidence Interval)
Unit of Measure: months
4.0
(3.4 to 4.2)
2.1
(2.1 to 2.2)
4.2
(3.7 to 5.0)
2.4
(2.1 to 4.2)
4.1
(3.6 to 4.2)
2.1
(2.1 to 2.2)
3.Secondary Outcome
Title Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1
Hide Description 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.
Time Frame Up to approximately 25 months after first participant enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
DOR analyses was performed on the subset of patients who achieved an objective response.
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab IC2/3 Chemotherapy IC2/3 Atezolizumab IC1/2/3 Chemotherapy IC1/2/3 Atezolizumab
Hide Arm/Group Description:
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
Overall Number of Participants Analyzed 96 71 34 30 68 51
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(4.2 to 6.3)
21.7
(9.9 to 21.7)
6.4
(4.2 to 8.3)
13.0 [1] 
(6.6 to NA)
5.5
(4.2 to 7.4)
13 [1] 
(6.9 to NA)
[1]
The DOR data was not mature at the time of clinical cutoff (i.e., majority of the responders are still ongoing), so the upper confidence interval was not estimable.
4.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame Up to approximately 46 months after first participant enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab IC2/3 Chemotherapy IC2/3 Atezolizumab IC1/2/3 Chemotherapy IC1/2/3 Atezolizumab
Hide Arm/Group Description:
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
Overall Number of Participants Analyzed 443 459 112 114 297 312
Measure Type: Number
Unit of Measure: percentage
98.2 95.0 98.2 96.5 98.7 96.2
5.Secondary Outcome
Title Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result.
Arm/Group Title Atezolizumab IC1/2/3 Atezolizumab IC2/3 Atezolizumab
Hide Arm/Group Description:
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC2/3
Overall Number of Participants Analyzed 427 289 106
Measure Type: Number
Unit of Measure: percentage of participants
33.3 35.0 33.0
6.Secondary Outcome
Title Minimum Observed Serum Atezolizumab Concentration (Cmin)
Hide Description Cmin was measured for all participants that received at least one dose of Atezolizumab.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
Overall Number of Participants Analyzed 467
Geometric Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 2, day 1 Number Analyzed 399 participants
67.5  (29.1)
Cycle 3, day 1 Number Analyzed 341 participants
95.1  (46.5)
Cycle 4, day 1 Number Analyzed 259 participants
122  (56.9)
Cycle 8, day 1 Number Analyzed 156 participants
159  (72.4)
Cycle 16, day 1 Number Analyzed 79 participants
190  (94.7)
Cycle 24, day 1 Number Analyzed 30 participants
190  (98.7)
Cycle 32, day 1 Number Analyzed 8 participants
223  (87.4)
7.Secondary Outcome
Title 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)
Hide Description 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
Time Frame Up to approximately 25 months after first participant enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
ORR analyses was performed on all randomized patients who had measureable disease at baseline
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab IC2/3 Chemotherapy IC2/3 Atezolizumab IC1/2/3 Chemotherapy IC1/2/3 Atezolizumab
Hide Arm/Group Description:
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
Overall Number of Participants Analyzed 461 462 116 113 306 312
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
20.8
(17.21 to 24.82)
15.4
(12.20 to 18.99)
29.3
(21.23 to 38.48)
26.5
(18.68 to 35.68)
22.2
(17.69 to 27.30)
16.3
(12.42 to 20.93)
8.Secondary Outcome
Title Maximum Observed Serum Atezolizumab Concentration (Cmax)
Hide Description Cmax was measured for all participants that received at least one dose of Atezolizumab.
Time Frame 30 minutes post dose on Day 1 of Cycles 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
Overall Number of Participants Analyzed 467
Geometric Mean (Standard Deviation)
Unit of Measure: mcg/mL
334  (125)
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Hide Arm/Group Description:
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
Overall Number of Participants Analyzed 381 408
Mean (Standard Deviation)
Unit of Measure: units of a scale
Baseline (Cycle 1, Day 1) Number Analyzed 380 participants 407 participants
61.49  (22.30) 64.19  (21.72)
Change from baseline: Cycle 2, Day 1 Number Analyzed 349 participants 379 participants
-5.47  (20.02) -6.18  (20.07)
Change from baseline: Cycle 3, Day 1 Number Analyzed 299 participants 328 participants
-3.76  (22.34) -4.67  (20.89)
Change from baseline: Cycle 4, Day 1 Number Analyzed 203 participants 250 participants
-1.48  (19.71) -0.53  (20.23)
Change from baseline: Cycle 12, Day 1 Number Analyzed 38 participants 104 participants
-3.95  (24.33) -0.56  (22.31)
Change from baseline: Cycle 20, Day 1 Number Analyzed 11 participants 68 participants
-2.27  (16.28) 1.10  (21.88)
Change from baseline: Cycle 28, Day 1 Number Analyzed 5 participants 19 participants
-11.67  (7.45) -5.26  (33.82)
Change from baseline:Treatment Discont. Visit Number Analyzed 267 participants 200 participants
-10.77  (24.15) -16.71  (24.39)
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Hide Arm/Group Description:
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
Overall Number of Participants Analyzed 381 408
Mean (Standard Deviation)
Unit of Measure: units of a scale
Baseline (Cycle 1, Day 1) Number Analyzed 381 participants 408 participants
74.23  (22.55) 76.37  (19.66)
Change from baseline: Cycle 2, Day 1 Number Analyzed 351 participants 385 participants
-4.80  (15.70) -7.56  (18.24)
Change from baseline: Cycle 3, Day 1 Number Analyzed 303 participants 331 participants
-5.64  (17.37) -7.06  (19.62)
Change from baseline: Cycle 4, Day 1 Number Analyzed 202 participants 254 participants
-4.41  (16.25) -3.81  (17.49)
Change from baseline: Cycle 12, Day 1 Number Analyzed 39 participants 105 participants
-6.97  (20.20) 0.89  (16.23)
Change from baseline: Cycle 20, Day 1 Number Analyzed 11 participants 69 participants
-3.03  (11.30) 3.48  (13.56)
Change from baseline: Cycle 28, Day 1 Number Analyzed 5 participants 19 participants
-18.67  (24.68) 3.51  (20.53)
Change from baseline: Treatment Discont. Visit Number Analyzed 267 participants 201 participants
-15.58  (25.67) -20.19  (25.52)
11.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Hide Arm/Group Description:
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
Overall Number of Participants Analyzed 381 408
Mean (Standard Deviation)
Unit of Measure: units of a scale
Fatigue Symptom: Baseline (Cycle 1, Day 1) Number Analyzed 381 participants 408 participants
34.67  (26.66) 32.87  (23.88)
Fatigue Symptom: Cycle 2, Day 1 Number Analyzed 350 participants 385 participants
10.71  (23.13) 10.56  (21.82)
Change from baseline: Cycle 3, Day 1 Number Analyzed 302 participants 329 participants
11.04  (25.48) 9.41  (24.80)
Change from baseline: Cycle 4, Day 1 Number Analyzed 202 participants 254 participants
7.48  (22.63) 3.67  (23.57)
Change from baseline: Cycle 12, Day 1 Number Analyzed 39 participants 105 participants
5.70  (27.44) -0.95  (23.27)
Change from baseline: Cycle 20, Day 1 Number Analyzed 11 participants 69 participants
11.11  (28.97) -8.05  (21.97)
Change from baseline: Cycle 28, Day 1 Number Analyzed 5 participants 19 participants
15.56  (16.85) -12.28  (28.42)
Change from baseline: Treatment Discont. Visit Number Analyzed 267 participants 201 participants
17.27  (28.15) 19.60  (25.95)
Time Frame From the first study drug to the data cutoff date: 8 Nov 2018 (up to 46 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Hide Arm/Group Description 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. Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued 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.
All-Cause Mortality
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   393/443 (88.71%)      379/459 (82.57%)    
Hide Serious Adverse Events
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   189/443 (42.66%)      192/459 (41.83%)    
Blood and lymphatic system disorders     
Anemia † 1  5/443 (1.13%)  5 9/459 (1.96%)  9
Bone Marrow Failure † 1  2/443 (0.45%)  2 0/459 (0.00%)  0
Febrile Neutropenia † 1  22/443 (4.97%)  25 1/459 (0.22%)  1
Neutropenia † 1  14/443 (3.16%)  15 0/459 (0.00%)  0
Thrombocytopenia † 1  1/443 (0.23%)  1 2/459 (0.44%)  2
Cardiac disorders     
Acute Coronary Syndrome † 1  2/443 (0.45%)  2 0/459 (0.00%)  0
Acute Myocardial Infarction † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Angina Pectoris † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Atrial Fibrillation † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Atrioventricular Block † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Cardiac Arrest † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Cardio-Respiratory Arrest † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Myocardial Infarction † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Pericardial Effusion † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Endocrine disorders     
Hyperthyroidism † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Hypothyroidism † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Adrenal Insufficiency † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Eye disorders     
Cataract † 1  1/443 (0.23%)  1 1/459 (0.22%)  2
Macular Fibrosis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Papilloedema † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Visual Impairment † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Gastrointestinal disorders     
Abdominal Pain † 1  9/443 (2.03%)  9 5/459 (1.09%)  5
Abdominal Pain Lower † 1  0/443 (0.00%)  0 3/459 (0.65%)  3
Anal Haemorrhage † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Ascites † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Autoimmune Colitis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Colitis † 1  0/443 (0.00%)  0 3/459 (0.65%)  3
Colitis Ulcerative † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Constipation † 1  20/443 (4.51%)  23 2/459 (0.44%)  2
Diarrhoea † 1  3/443 (0.68%)  3 6/459 (1.31%)  6
Duodenal Obstruction † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Enteritis † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Enterocolitis † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Enterovesical Fistula † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Gastric Haemorrhage † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Gastrointestinal Haemorrhage † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Ileal Perforation † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Ileus † 1  6/443 (1.35%)  6 1/459 (0.22%)  2
Inguinal Hernia † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Intestinal Obstruction † 1  2/443 (0.45%)  2 2/459 (0.44%)  2
Intestinal Perforation † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Jejunal Perforation † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Large Intestinal Obstruction † 1  2/443 (0.45%)  2 2/459 (0.44%)  2
Nausea † 1  4/443 (0.90%)  4 0/459 (0.00%)  0
Pancreatitis † 1  0/443 (0.00%)  0 3/459 (0.65%)  3
Rectal Haemorrhage † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Small Intestinal Obstruction † 1  4/443 (0.90%)  4 1/459 (0.22%)  1
Subileus † 1  4/443 (0.90%)  4 2/459 (0.44%)  3
Vomiting † 1  2/443 (0.45%)  2 4/459 (0.87%)  5
Dysphagia † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Enterocolitis Haemorrhagic † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Gastrointestinal Disorder † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
General disorders     
Death † 1  2/443 (0.45%)  2 3/459 (0.65%)  3
Fatigue † 1  5/443 (1.13%)  6 4/459 (0.87%)  4
General Physical Health Deterioration † 1  4/443 (0.90%)  4 2/459 (0.44%)  2
Influenza Like Illness † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Injection Site Reaction † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Malaise † 1  2/443 (0.45%)  2 1/459 (0.22%)  1
Multiple Organ Dysfunction Syndrome † 1  2/443 (0.45%)  2 0/459 (0.00%)  0
Non-Cardiac Chest Pain † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Obstruction † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Oedema † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Oedema Peripheral † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Pain † 1  4/443 (0.90%)  4 3/459 (0.65%)  3
Peripheral Swelling † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Pyrexia † 1  5/443 (1.13%)  5 17/459 (3.70%)  18
Strangulated Hernia † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Asthenia † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Unevaluable Event † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Hepatobiliary disorders     
Autoimmune Hepatitis † 1  0/443 (0.00%)  0 4/459 (0.87%)  5
Biliary Dilation † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Cholecystitis † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Hepatocellular Injury † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Hyperbilirubinaemia † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Jaundice † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Portal Vein Thrombosis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Immune system disorders     
Drug Hypersensitivity † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Hypersensitivity † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Infections and infestations     
Arthritis Infective † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Bacteraemia † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Bacterial Infection † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Bronchitis † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Cystitis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Device Related Infection † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Enterococcal Infection † 1  1/443 (0.23%)  2 0/459 (0.00%)  0
Enterococcal Sepsis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Erysipelas † 1  1/443 (0.23%)  1 1/459 (0.22%)  3
Escherichia Infection † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Escherichia Pyelonephritis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Escherichia Sepsis † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Gastroenteritis † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Infection † 1  3/443 (0.68%)  3 1/459 (0.22%)  1
Kidney Infection † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Klebsiella Infection † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Lower Respiratory Tract Infection † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Lung Infection † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Meningoencephalitis Viral † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Neutropenic Infection † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Neutropenic Sepsis † 1  2/443 (0.45%)  2 0/459 (0.00%)  0
Ophthalmic Herpes Zoster † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Peritonitis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Pneumonia † 1  7/443 (1.58%)  7 4/459 (0.87%)  5
Pyelonephritis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Respiratory Tract Infection † 1  1/443 (0.23%)  1 3/459 (0.65%)  3
Sepsis † 1  15/443 (3.39%)  16 8/459 (1.74%)  8
Septic Shock † 1  2/443 (0.45%)  2 2/459 (0.44%)  2
Spinal Cord Infection † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Staphylococcal Infection † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Toxic Shock Syndrome † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Urinary Tract Infection † 1  14/443 (3.16%)  17 21/459 (4.58%)  25
Urinary Tract Infection Bacterial † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Urosepsis † 1  12/443 (2.71%)  12 2/459 (0.44%)  2
Escherichia Bacteraemia † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Influenza † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Pyonephrosis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Vascular Device Infection † 1  4/443 (0.90%)  4 0/459 (0.00%)  0
Injury, poisoning and procedural complications     
Compression Fracture † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Femoral Neck Fracture † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Infusion Related Reaction † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Lower Limb Fracture † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Lumbar Vertebral Fracture † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Spinal Compression Fracture † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Stoma Site Haemorrhage † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Toxicity to Various Agents † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Urostomy Complication † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Skin Injury † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Investigations     
Alanine Aminotransferase Increased † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Aspartate Aminotransferase Increased † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Blood Bilirubin Increased † 1  1/443 (0.23%)  1 2/459 (0.44%)  2
Blood Creatinine Increased † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Liver Function Test Abnormal † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Neutrophil Count Decreased † 1  4/443 (0.90%)  4 0/459 (0.00%)  0
Platelet Count Decreased † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Transaminases Increased † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
White Blood Cell Count Decreased † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Gamma-Glutamyltransferase Increased † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Metabolism and nutrition disorders     
Decreased Appetite † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Dehydration † 1  3/443 (0.68%)  4 2/459 (0.44%)  2
Diabetes Mellitus † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Diabetic Ketoacidosis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Failure to Thrive † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Hypercalcaemia † 1  1/443 (0.23%)  1 3/459 (0.65%)  3
Hyperkalaemia † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Hyperglycaemia † 1  0/443 (0.00%)  0 1/459 (0.22%)  2
Hypokalaemia † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Hyponatraemia † 1  3/443 (0.68%)  3 4/459 (0.87%)  4
Hypoglycaemia † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Back Pain † 1  4/443 (0.90%)  4 6/459 (1.31%)  6
Bone Pain † 1  3/443 (0.68%)  3 1/459 (0.22%)  1
Groin Pain † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Myalgia † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Myositis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Pain in Extremity † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Pathological Fracture † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Rhabdomyolysis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Arthritis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Gouty Arthritis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Osteoarthritis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon Cancer † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Mantle Cell Lymphoma † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Neoplasm Malignant † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Tumor Associated Fever † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Cancer Pain † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Gastric Cancer † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Nervous system disorders     
Brain Oedema † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Dizziness † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Dyskinesia † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Epilepsy † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Headache † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Ischaemic Stroke † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Leukoencephalopathy † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Radiculopathy † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Sciatica † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Syncope † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Transient Ischaemic Attack † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Parkinson's Disease † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Product Issues     
Device Dislocation † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Device Occlusion † 1  3/443 (0.68%)  5 1/459 (0.22%)  2
Psychiatric disorders     
Completed Suicide † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Confusional State † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury † 1  6/443 (1.35%)  6 11/459 (2.40%)  12
Anuria † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Bladder Perforation † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Bladder Tamponade † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Haematuria † 1  7/443 (1.58%)  9 10/459 (2.18%)  19
Hydronephrosis † 1  0/443 (0.00%)  0 3/459 (0.65%)  3
Postrenal Failure † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Renal Failure † 1  5/443 (1.13%)  5 4/459 (0.87%)  4
Renal Haematoma † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Urethral Haemorrhage † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Urinary Bladder Haemorrhage † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Urinary Retention † 1  1/443 (0.23%)  1 6/459 (1.31%)  6
Urinary Tract Obstruction † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Urinary Tract Pain † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Urinoma † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Reproductive system and breast disorders     
Vaginal Haemorrhage † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Genital Haemorrhage † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  0/443 (0.00%)  0 7/459 (1.53%)  7
Pleural Effusion † 1  1/443 (0.23%)  1 2/459 (0.44%)  2
Pneumonia Aspiration † 1  1/443 (0.23%)  1 1/459 (0.22%)  1
Pneumonitis † 1  2/443 (0.45%)  2 4/459 (0.87%)  4
Pneumothorax † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Productive Cough † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Pulmonary Embolism † 1  2/443 (0.45%)  2 4/459 (0.87%)  4
Respiratory Distress † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Respiratory Failure † 1  0/443 (0.00%)  0 2/459 (0.44%)  2
Haemoptysis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Skin and subcutaneous tissue disorders     
Psoriasis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Toxic Epidermal Necrolysis † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Vascular disorders     
Deep Vein Thrombosis † 1  2/443 (0.45%)  2 4/459 (0.87%)  4
Embolism † 1  0/443 (0.00%)  0 1/459 (0.22%)  1
Hypertension † 1  2/443 (0.45%)  2 0/459 (0.00%)  0
Thrombophlebitis † 1  3/443 (0.68%)  3 0/459 (0.00%)  0
Thrombosis † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
Internal Haemorrhage † 1  1/443 (0.23%)  1 0/459 (0.00%)  0
1
Term from vocabulary, MedDRA (21.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) Atezolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   417/443 (94.13%)      413/459 (89.98%)    
Blood and lymphatic system disorders     
Anaemia † 1  124/443 (27.99%)  142 90/459 (19.61%)  94
Neutropenia † 1  57/443 (12.87%)  75 5/459 (1.09%)  6
Gastrointestinal disorders     
Abdominal Pain † 1  58/443 (13.09%)  63 52/459 (11.33%)  60
Abdominal Pain Upper † 1  27/443 (6.09%)  32 23/459 (5.01%)  23
Constipation † 1  163/443 (36.79%)  221 131/459 (28.54%)  147
Diarrhoea † 1  94/443 (21.22%)  115 97/459 (21.13%)  145
Dry Mouth † 1  8/443 (1.81%)  8 30/459 (6.54%)  36
Nausea † 1  137/443 (30.93%)  171 106/459 (23.09%)  124
Stomatitis † 1  35/443 (7.90%)  41 13/459 (2.83%)  16
Vomiting † 1  81/443 (18.28%)  108 55/459 (11.98%)  67
General disorders     
Asthenia † 1  107/443 (24.15%)  144 92/459 (20.04%)  108
Fatigue † 1  136/443 (30.70%)  162 129/459 (28.10%)  153
Mucosal Inflammation † 1  47/443 (10.61%)  64 27/459 (5.88%)  30
Oedema Peripheral † 1  36/443 (8.13%)  43 52/459 (11.33%)  59
Pain † 1  31/443 (7.00%)  34 24/459 (5.23%)  24
Pyrexia † 1  62/443 (14.00%)  76 93/459 (20.26%)  128
Infections and infestations     
Nasopharyngitis † 1  11/443 (2.48%)  15 27/459 (5.88%)  43
Urinary Tract Infection † 1  58/443 (13.09%)  76 84/459 (18.30%)  141
Investigations     
Blood Creatinine Increased † 1  11/443 (2.48%)  12 36/459 (7.84%)  38
Neutrophil Count Decreased † 1  26/443 (5.87%)  49 0/459 (0.00%)  0
Weight Decreased † 1  45/443 (10.16%)  46 47/459 (10.24%)  47
Metabolism and nutrition disorders     
Decreased Appetite † 1  113/443 (25.51%)  136 135/459 (29.41%)  147
Hypokalaemia † 1  23/443 (5.19%)  26 16/459 (3.49%)  17
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  60/443 (13.54%)  79 47/459 (10.24%)  66
Back Pain † 1  51/443 (11.51%)  53 80/459 (17.43%)  95
Bone Pain † 1  24/443 (5.42%)  28 24/459 (5.23%)  27
Myalgia † 1  55/443 (12.42%)  68 25/459 (5.45%)  27
Pain in Extremity † 1  48/443 (10.84%)  55 37/459 (8.06%)  46
Nervous system disorders     
Dizziness † 1  30/443 (6.77%)  32 29/459 (6.32%)  29
Dysgeusia † 1  25/443 (5.64%)  27 12/459 (2.61%)  14
Headache † 1  26/443 (5.87%)  35 38/459 (8.28%)  44
Neuropathy Peripheral † 1  55/443 (12.42%)  67 8/459 (1.74%)  9
Paraesthesia † 1  29/443 (6.55%)  32 18/459 (3.92%)  18
Peripheral Sensory Neuropathy † 1  41/443 (9.26%)  43 6/459 (1.31%)  7
Psychiatric disorders     
Anxiety † 1  24/443 (5.42%)  24 27/459 (5.88%)  27
Insomnia † 1  42/443 (9.48%)  42 45/459 (9.80%)  48
Renal and urinary disorders     
Haematuria † 1  26/443 (5.87%)  32 45/459 (9.80%)  60
Respiratory, thoracic and mediastinal disorders     
Cough † 1  30/443 (6.77%)  36 59/459 (12.85%)  69
Dyspnoea † 1  46/443 (10.38%)  50 62/459 (13.51%)  70
Skin and subcutaneous tissue disorders     
Alopecia † 1  125/443 (28.22%)  127 1/459 (0.22%)  1
Pruritus † 1  19/443 (4.29%)  27 64/459 (13.94%)  86
Rash † 1  28/443 (6.32%)  37 54/459 (11.76%)  72
Vascular disorders     
Hypertension † 1  20/443 (4.51%)  22 23/459 (5.01%)  24
1
Term from vocabulary, MedDRA (21.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02302807    
Other Study ID Numbers: GO29294
2014-003231-19 ( EudraCT Number )
First Submitted: November 25, 2014
First Posted: November 27, 2014
Results First Submitted: March 13, 2018
Results First Posted: April 11, 2018
Last Update Posted: August 1, 2019