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← KEYTRUDA QLEX: metastatic Urothelial carcinoma (neoadjuvant) after prior therapy

NCT02603432 · STUDY IN CONTEXT

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

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

Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.

The full analysis set included all randomized participants.

→

secondary · POSTED

BICR assessed PFS: Duration from randomization until disease progression (PD) or death. PD as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.

The full analysis set included all randomized participants.

→

secondary · POSTED

Investigator assessed PFS: Duration from randomization to first documentation of PD or death, whichever occurred first. PD as per RECIST version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started a new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.

The full analysis set included all randomized participants.

→

secondary · POSTED

BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.

The full analysis set included all randomized participants.

→

secondary · POSTED

Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.

The full analysis set included all randomized participants.

→

secondary · POSTED

TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR), which was confirmed subsequently. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.

The full analysis set included all randomized participants. Here, 'Overall Number of participants analyzed (N)' signifies participants who were evaluable for this outcome measure (OM).

→

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 National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6

Score direction: Higher 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-keytruda-qlex-6b2249a8
nct id
NCT02603432
qol key
qol-0022
source section id
NCT02603432-om-0022
source outcome index
22
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6
measure definition
NCCN-FACT FBlSI-18 is an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms- physical subscale with 9 items, disease related symptoms- emotional subscale with 2 items, treatment side effects subscale with 5 items and general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging from 0=not at all to 4=very much. Items that were negatively framed, and the scores were reversed for analysis so that higher scores= good quality of life. Overall score: total of 18 items, ranging from 0=severely symptomatic to 72=asymptomatic. Higher scores= better functioning or lower symptom burden.
time frame
Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores= better
population note
The full analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants who had data available for this outcome measure and 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores

Score direction: Higher 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-keytruda-qlex-6b2249a8
nct id
NCT02603432
qol key
qol-0023
source section id
NCT02603432-om-0023
source outcome index
23
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
measure definition
NCCN-FACT FBlSI-18: an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.
time frame
From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores=better
population note
The full analysis set included all randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6

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-keytruda-qlex-6b2249a8
nct id
NCT02603432
qol key
qol-0024
source section id
NCT02603432-om-0024
source outcome index
24
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6
measure definition
The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published UK weights was used to create a single summary utility score. Utility scores range from -0.594 to 1, with low scores representing lower health status.
time frame
Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The full analysis set included all participants who were randomized. Here, 'Overall number of participants analyzed' signifies participants who had data available for this outcome measure and 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6

Score direction: Higher 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-keytruda-qlex-6b2249a8
nct id
NCT02603432
qol key
qol-0025
source section id
NCT02603432-om-0025
source outcome index
25
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6
measure definition
The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
time frame
Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating a better
population note
The full analysis set included all participants who were randomized. Here, 'Overall number of participants analyzed' signifies participants who had data available for this outcome measure and 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
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-keytruda-qlex-6b2249a8
nct id
NCT02603432
trial label
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
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
2
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0000
    source section id
    NCT02603432-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
    time origin
    From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set included all randomized participants.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0001
    source section id
    NCT02603432-om-0001
    source outcome index
    1
    endpoint
    Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
    endpoint definition
    BICR assessed PFS: Duration from randomization until disease progression (PD) or death. PD as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.
    time origin
    From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set included all randomized participants.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0002
    source section id
    NCT02603432-om-0002
    source outcome index
    2
    endpoint
    Progression-Free Survival (PFS) as Assessed by Investigator
    endpoint definition
    Investigator assessed PFS: Duration from randomization to first documentation of PD or death, whichever occurred first. PD as per RECIST version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started a new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.
    time origin
    From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set included all randomized participants.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0003
    source section id
    NCT02603432-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
    endpoint definition
    BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
    time origin
    From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set included all randomized participants.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0004
    source section id
    NCT02603432-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Objective Response as Assessed by Investigator
    endpoint definition
    Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
    time origin
    From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set included all randomized participants.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0005
    source section id
    NCT02603432-om-0005
    source outcome index
    5
    endpoint
    Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR)
    endpoint definition
    TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR), which was confirmed subsequently. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
    time origin
    From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set included all randomized participants. Here, 'Overall Number of participants analyzed (N)' signifies participants who were evaluable for this outcome measure (OM).
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Avelumab + Best Supportive Care (BSC)
    regimen
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Best Supportive Care
    regimen
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Avelumab + Best Supportive Care (BSC)
    regimen
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Best Supportive Care
    regimen
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Avelumab + Best Supportive Care (BSC)
    regimen
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Best Supportive Care
    regimen
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Avelumab + Best Supportive Care (BSC)
    regimen
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Best Supportive Care
    regimen
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Avelumab + Best Supportive Care (BSC)
    regimen
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Best Supportive Care
    regimen
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Avelumab + Best Supportive Care (BSC)
    regimen
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Best Supportive Care
    regimen
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02603432-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    harm key
    EG000
    source section id
    NCT02603432-ae
    event group key
    EG000
    event group label
    Avelumab + Best Supportive Care (BSC)
    serious affected
    111
    serious at risk
    344
    other affected
    321
    other at risk
    344
    frequency threshold
    5
    collection period
    For ''Avelumab + Best Supportive Care (BSC)'' reporting group: Day 1 up to 90 days after last dose of study drug and for ''Best Supportive Care'' reporting group: Day 1 up to 90 days after end of treatment visit, for a maximum duration of up to 70 months for both groups.
    event definition
    Same event may appear as both non-SAE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-Cause Mortality, SAEs and non-SAEs were assessed in Safety Analysis set.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    harm key
    EG001
    source section id
    NCT02603432-ae
    event group key
    EG001
    event group label
    Best Supportive Care
    serious affected
    73
    serious at risk
    345
    other affected
    214
    other at risk
    345
    frequency threshold
    5
    collection period
    For ''Avelumab + Best Supportive Care (BSC)'' reporting group: Day 1 up to 90 days after last dose of study drug and for ''Best Supportive Care'' reporting group: Day 1 up to 90 days after end of treatment visit, for a maximum duration of up to 70 months for both groups.
    event definition
    Same event may appear as both non-SAE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-Cause Mortality, SAEs and non-SAEs were assessed in Safety Analysis set.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    qol key
    qol-0022
    source section id
    NCT02603432-om-0022
    source outcome index
    22
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6
    measure definition
    NCCN-FACT FBlSI-18 is an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms- physical subscale with 9 items, disease related symptoms- emotional subscale with 2 items, treatment side effects subscale with 5 items and general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging from 0=not at all to 4=very much. Items that were negatively framed, and the scores were reversed for analysis so that higher scores= good quality of life. Overall score: total of 18 items, ranging from 0=severely symptomatic to 72=asymptomatic. Higher scores= better functioning or lower symptom burden.
    time frame
    Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores= better
    population note
    The full analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants who had data available for this outcome measure and 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    qol key
    qol-0023
    source section id
    NCT02603432-om-0023
    source outcome index
    23
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
    measure definition
    NCCN-FACT FBlSI-18: an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.
    time frame
    From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores=better
    population note
    The full analysis set included all randomized participants.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    qol key
    qol-0024
    source section id
    NCT02603432-om-0024
    source outcome index
    24
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6
    measure definition
    The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published UK weights was used to create a single summary utility score. Utility scores range from -0.594 to 1, with low scores representing lower health status.
    time frame
    Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The full analysis set included all participants who were randomized. Here, 'Overall number of participants analyzed' signifies participants who had data available for this outcome measure and 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
    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-keytruda-qlex-6b2249a8
    nct id
    NCT02603432
    qol key
    qol-0025
    source section id
    NCT02603432-om-0025
    source outcome index
    25
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6
    measure definition
    The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
    time frame
    Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores indicating a better
    population note
    The full analysis set included all participants who were randomized. Here, 'Overall number of participants analyzed' signifies participants who had data available for this outcome measure and 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
    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