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

NCT02516241 · STUDY IN CONTEXT

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

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

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.

→

primary · POSTED

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control

→

secondary · POSTED

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.

→

secondary · POSTED

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control

→

secondary · POSTED

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.

→

secondary · POSTED

Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.

Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.

→

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

FACT · Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02516241
qol key
qol-0034
source section id
NCT02516241-om-0034
source outcome index
34
instrument
FACT
instrument basis
matched 'fact-bl' in the study's own wording
scale title
Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
measure definition
the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse outcome.
time frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
Higher score represent worse
population note
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02516241
qol key
qol-0035
source section id
NCT02516241-om-0035
source outcome index
35
instrument
FACT
instrument basis
matched 'fact-bl' in the study's own wording
scale title
Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
measure definition
the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse
time frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
Higher score represent worse
population note
The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT02516241
qol key
qol-0036
source section id
NCT02516241-om-0036
source outcome index
36
instrument
FACT
instrument basis
matched 'fact-bl' in the study's own wording
scale title
Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
measure definition
the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse
time frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
Higher score represent worse
population note
The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

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
NCT02516241
qol key
qol-0037
source section id
NCT02516241-om-0037
source outcome index
37
instrument
FACT
instrument basis
matched 'fact-bl' in the study's own wording
scale title
Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
measure definition
Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
time frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

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
NCT02516241
qol key
qol-0038
source section id
NCT02516241-om-0038
source outcome index
38
instrument
FACT
instrument basis
matched 'fact-bl' in the study's own wording
scale title
Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
measure definition
Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
time frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

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
NCT02516241
qol key
qol-0039
source section id
NCT02516241-om-0039
source outcome index
39
instrument
FACT
instrument basis
matched 'fact-bl' in the study's own wording
scale title
Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
measure definition
Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
time frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
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
NCT02516241
trial label
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
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
6
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0000
    source section id
    NCT02516241-om-0000
    source outcome index
    0
    endpoint
    To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set
    endpoint definition
    The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
    time origin
    From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
    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
    NCT02516241
    outcome key
    om-0001
    source section id
    NCT02516241-om-0001
    source outcome index
    1
    endpoint
    To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set
    endpoint definition
    The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
    time origin
    From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control
    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
    NCT02516241
    outcome key
    om-0002
    source section id
    NCT02516241-om-0002
    source outcome index
    2
    endpoint
    OS, Full Analysis Set - Durvalumab Monotherapy vs SoC
    endpoint definition
    The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
    time origin
    From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
    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
    NCT02516241
    outcome key
    om-0003
    source section id
    NCT02516241-om-0003
    source outcome index
    3
    endpoint
    OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC
    endpoint definition
    The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
    time origin
    From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control
    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
    NCT02516241
    outcome key
    om-0004
    source section id
    NCT02516241-om-0004
    source outcome index
    4
    endpoint
    OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
    endpoint definition
    The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
    time origin
    From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
    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
    NCT02516241
    outcome key
    om-0005
    source section id
    NCT02516241-om-0005
    source outcome index
    5
    endpoint
    Alive at 24 Months (OS24), Full Analysis Set
    endpoint definition
    Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
    time origin
    From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
    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
    NCT02516241
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Combination Therapy
    regimen
    MEDI4736 (Durvalumab) + Tremelimumab
    analyzed count
    342
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Standard of Care
    regimen
    Standard of Care Chemotherapy Treatment
    analyzed count
    344
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Monotherapy
    regimen
    MEDI4736 (Durvalumab)
    analyzed count
    209
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Standard of Care
    regimen
    Standard of Care Chemotherapy Treatment
    analyzed count
    207
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Monotherapy
    regimen
    MEDI4736 (Durvalumab)
    analyzed count
    346
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Standard of Care
    regimen
    Standard of Care Chemotherapy Treatment
    analyzed count
    344
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Combination Therapy
    regimen
    MEDI4736 (Durvalumab) + Tremelimumab
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Standard of Care
    regimen
    Standard of Care Chemotherapy Treatment
    analyzed count
    207
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Combination Therapy
    regimen
    MEDI4736 (Durvalumab) + Tremelimumab
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Monotherapy
    regimen
    MEDI4736 (Durvalumab)
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0004
    arm key
    OG002
    arm label
    Standard of Care
    regimen
    Standard of Care Chemotherapy Treatment
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0004#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Combination Therapy
    regimen
    MEDI4736 (Durvalumab) + Tremelimumab
    analyzed count
    342
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02516241-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT02516241
    harm key
    EG000
    source section id
    NCT02516241-ae
    event group key
    EG000
    event group label
    Combination Therapy
    serious affected
    179
    serious at risk
    340
    other affected
    306
    other at risk
    340
    frequency threshold
    5
    collection period
    From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).
    event definition
    Source null
    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
    NCT02516241
    harm key
    EG001
    source section id
    NCT02516241-ae
    event group key
    EG001
    event group label
    Monotherapy
    serious affected
    139
    serious at risk
    345
    other affected
    312
    other at risk
    345
    frequency threshold
    5
    collection period
    From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).
    event definition
    Source null
    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
    NCT02516241
    harm key
    EG002
    source section id
    NCT02516241-ae
    event group key
    EG002
    event group label
    Standard of Care
    serious affected
    125
    serious at risk
    313
    other affected
    299
    other at risk
    313
    frequency threshold
    5
    collection period
    From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).
    event definition
    Source null
    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
    NCT02516241
    qol key
    qol-0034
    source section id
    NCT02516241-om-0034
    source outcome index
    34
    instrument
    FACT
    instrument basis
    matched 'fact-bl' in the study's own wording
    scale title
    Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
    measure definition
    the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse outcome.
    time frame
    At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    Higher score represent worse
    population note
    Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
    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
    NCT02516241
    qol key
    qol-0035
    source section id
    NCT02516241-om-0035
    source outcome index
    35
    instrument
    FACT
    instrument basis
    matched 'fact-bl' in the study's own wording
    scale title
    Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
    measure definition
    the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse
    time frame
    At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    Higher score represent worse
    population note
    The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control
    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
    NCT02516241
    qol key
    qol-0036
    source section id
    NCT02516241-om-0036
    source outcome index
    36
    instrument
    FACT
    instrument basis
    matched 'fact-bl' in the study's own wording
    scale title
    Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
    measure definition
    the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse
    time frame
    At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    Higher score represent worse
    population note
    The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
    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
    NCT02516241
    qol key
    qol-0037
    source section id
    NCT02516241-om-0037
    source outcome index
    37
    instrument
    FACT
    instrument basis
    matched 'fact-bl' in the study's own wording
    scale title
    Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
    measure definition
    Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
    time frame
    At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
    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
    NCT02516241
    qol key
    qol-0038
    source section id
    NCT02516241-om-0038
    source outcome index
    38
    instrument
    FACT
    instrument basis
    matched 'fact-bl' in the study's own wording
    scale title
    Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
    measure definition
    Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
    time frame
    At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
    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
    NCT02516241
    qol key
    qol-0039
    source section id
    NCT02516241-om-0039
    source outcome index
    39
    instrument
    FACT
    instrument basis
    matched 'fact-bl' in the study's own wording
    scale title
    Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
    measure definition
    Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
    time frame
    At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
    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