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← Imfinzi: metastatic Urothelial carcinoma (neoadjuvant) after prior therapy

NCT02807636 · STUDY IN CONTEXT

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first.

The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.

→

primary · POSTED

OS is defined as the time from randomization to death due to any cause.

The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.

→

primary · POSTED

OS is defined as the time from randomization to death due to any cause.

The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.

→

secondary · POSTED

Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.

The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.

→

secondary · POSTED

Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.

The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.

→

secondary · POSTED

Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.

The duration of response (DOR)-evaluable population is defined as participants with an objective response in the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02807636
qol key
qol-0011
source section id
NCT02807636-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
measure definition
Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
time frame
Up to approximately 73 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The patient reported outcome (PRO)-evaluable population is defined as participants in the ITT populations for comparisons of the Placebo+Chemo Arm versus Atezolizumab+Chemo Arm who have a baseline and at least one post-baseline assessment. The ITT population for the comparison of Atezo+Chemo Arm vs. Placebo+Chemo Arm included participants enrolled in Stage 1 and Stage 2, which consisted of 451 paarticipants in the Atezo+Chemo Arm and 400 participants in the Placebo+Chemo Arm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02807636
qol key
qol-0012
source section id
NCT02807636-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
measure definition
Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Chemo Arm versus Atezolizumab Monotherapy Arm.
time frame
Up to approximately 73 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Evaluable population defined as patients in ITT for comparisons of Placebo+Chemo vs. Atezo Mono who have a baseline and at least one post-baseline assessment. ITT for comparison of Atezo Mono vs. Placebo+Chemo consisted of 360 patients enrolled in Atezo Mono in Stage 2. Although a total of 400 patients were randomized to Placebo+Chemo throughout study, only 359 patients who were concurrently enrolled into this arm in Stage 2 and prior to Protocol v6 were included in Placebo+Chemo of this ITT.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02807636
qol key
qol-0013
source section id
NCT02807636-om-0013
source outcome index
13
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
measure definition
Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
time frame
Up to approximately 73 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The patient reported outcome (PRO)-evaluable population is defined as participants in the ITT populations for comparisons of the Placebo+Chemo Arm versus Atezolizumab+Chemo Arm who have a baseline and at least one post-baseline assessment. The ITT population for the comparison of Atezo+Chemo Arm vs. Placebo+Chemo Arm included participants enrolled in Stage 1 and Stage 2, which consisted of 451 paarticipants in the Atezo+Chemo Arm and 400 participants in the Placebo+Chemo Arm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02807636
qol key
qol-0014
source section id
NCT02807636-om-0014
source outcome index
14
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
measure definition
Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab Monotherapy Arm.
time frame
Up to approximately 73 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Evaluable population defined as patients in ITT for comparisons of Placebo+Chemo vs. Atezo Mono who have a baseline and at least one post-baseline assessment. ITT for comparison of Atezo Mono vs. Placebo+Chemo consisted of 360 patients enrolled in Atezo Mono in Stage 2. Although a total of 400 patients were randomized to Placebo+Chemo throughout study, only 359 patients who were concurrently enrolled into this arm in Stage 2 and prior to Protocol v6 were included in Placebo+Chemo of this ITT.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02807636
trial label
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0000
    source section id
    NCT02807636-om-0000
    source outcome index
    0
    endpoint
    Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
    endpoint definition
    PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first.
    time origin
    Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0001
    source section id
    NCT02807636-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
    endpoint definition
    OS is defined as the time from randomization to death due to any cause.
    time origin
    Baseline until death due to any cause (up to approximately 73 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0002
    source section id
    NCT02807636-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
    endpoint definition
    OS is defined as the time from randomization to death due to any cause.
    time origin
    Baseline until death due to any cause (up to approximately 73 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0003
    source section id
    NCT02807636-om-0003
    source outcome index
    3
    endpoint
    Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
    endpoint definition
    Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.
    time origin
    Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0004
    source section id
    NCT02807636-om-0004
    source outcome index
    4
    endpoint
    Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
    endpoint definition
    Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.
    time origin
    Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0005
    source section id
    NCT02807636-om-0005
    source outcome index
    5
    endpoint
    Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
    endpoint definition
    Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
    time origin
    From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The duration of response (DOR)-evaluable population is defined as participants with an objective response in the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    451
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    451
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Placebo+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    359
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Atezolizumab Monotherapy
    regimen
    Eligible participants received open-label atezolizumab as monotherapy.
    analyzed count
    360
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Placebo+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    397
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    447
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Placebo+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    356
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Atezolizumab Monotherapy
    regimen
    Eligible participants received open-label atezolizumab as monotherapy.
    analyzed count
    359
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Placebo+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    178
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
    regimen
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    analyzed count
    215
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02807636-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    harm key
    EG000
    source section id
    NCT02807636-ae
    event group key
    EG000
    event group label
    Placebo+Gemcitabine+Carboplatin/Cisplatin
    serious affected
    197
    serious at risk
    389
    other affected
    379
    other at risk
    389
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
    event definition
    Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    harm key
    EG001
    source section id
    NCT02807636-ae
    event group key
    EG001
    event group label
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
    serious affected
    244
    serious at risk
    454
    other affected
    441
    other at risk
    454
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
    event definition
    Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    harm key
    EG002
    source section id
    NCT02807636-ae
    event group key
    EG002
    event group label
    Atezolizumab Monotherapy
    serious affected
    163
    serious at risk
    354
    other affected
    300
    other at risk
    354
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
    event definition
    Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    qol key
    qol-0011
    source section id
    NCT02807636-om-0011
    source outcome index
    11
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
    measure definition
    Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
    time frame
    Up to approximately 73 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The patient reported outcome (PRO)-evaluable population is defined as participants in the ITT populations for comparisons of the Placebo+Chemo Arm versus Atezolizumab+Chemo Arm who have a baseline and at least one post-baseline assessment. The ITT population for the comparison of Atezo+Chemo Arm vs. Placebo+Chemo Arm included participants enrolled in Stage 1 and Stage 2, which consisted of 451 paarticipants in the Atezo+Chemo Arm and 400 participants in the Placebo+Chemo Arm.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    qol key
    qol-0012
    source section id
    NCT02807636-om-0012
    source outcome index
    12
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
    measure definition
    Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Chemo Arm versus Atezolizumab Monotherapy Arm.
    time frame
    Up to approximately 73 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Evaluable population defined as patients in ITT for comparisons of Placebo+Chemo vs. Atezo Mono who have a baseline and at least one post-baseline assessment. ITT for comparison of Atezo Mono vs. Placebo+Chemo consisted of 360 patients enrolled in Atezo Mono in Stage 2. Although a total of 400 patients were randomized to Placebo+Chemo throughout study, only 359 patients who were concurrently enrolled into this arm in Stage 2 and prior to Protocol v6 were included in Placebo+Chemo of this ITT.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    qol key
    qol-0013
    source section id
    NCT02807636-om-0013
    source outcome index
    13
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
    measure definition
    Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
    time frame
    Up to approximately 73 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The patient reported outcome (PRO)-evaluable population is defined as participants in the ITT populations for comparisons of the Placebo+Chemo Arm versus Atezolizumab+Chemo Arm who have a baseline and at least one post-baseline assessment. The ITT population for the comparison of Atezo+Chemo Arm vs. Placebo+Chemo Arm included participants enrolled in Stage 1 and Stage 2, which consisted of 451 paarticipants in the Atezo+Chemo Arm and 400 participants in the Placebo+Chemo Arm.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02807636
    qol key
    qol-0014
    source section id
    NCT02807636-om-0014
    source outcome index
    14
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
    measure definition
    Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab Monotherapy Arm.
    time frame
    Up to approximately 73 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Evaluable population defined as patients in ITT for comparisons of Placebo+Chemo vs. Atezo Mono who have a baseline and at least one post-baseline assessment. ITT for comparison of Atezo Mono vs. Placebo+Chemo consisted of 360 patients enrolled in Atezo Mono in Stage 2. Although a total of 400 patients were randomized to Placebo+Chemo throughout study, only 359 patients who were concurrently enrolled into this arm in Stage 2 and prior to Protocol v6 were included in Placebo+Chemo of this ITT.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice