A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)

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

Read the full study record and all posted results →

Linked outcomes

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

primary · POSTED

PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was assessed by blinded independent central review (BICR) in all participants up through the primary analysis database cut-off date of 07-Sep-2016.

The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the primary analysis database cut-off date of 07-Sep-2016.

→

primary · POSTED

PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had PD-L1 positive tumors (combined positive score \[CPS\] ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.

The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. OS was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.

→

primary · POSTED

PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.

The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with a PD-L1 CPS ≥10% were considered to have a strongly PD-L1 positive tumor status. The OS was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.

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Reported safety

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

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-opdivo-432072c9
nct id: NCT02256436
trial label: A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)
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: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0000
source section id
NCT02256436-om-0000
source outcome index
0
endpoint
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants
endpoint definition
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was assessed by blinded independent central review (BICR) in all participants up through the primary analysis database cut-off date of 07-Sep-2016.
time origin
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0001
source section id
NCT02256436-om-0001
source outcome index
1
endpoint
Overall Survival (OS) - All Participants
endpoint definition
OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the primary analysis database cut-off date of 07-Sep-2016.
time origin
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0002
source section id
NCT02256436-om-0002
source outcome index
2
endpoint
PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors
endpoint definition
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had PD-L1 positive tumors (combined positive score \[CPS\] ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.
time origin
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0003
source section id
NCT02256436-om-0003
source outcome index
3
endpoint
OS - Participants With PD-L1 Positive Tumors
endpoint definition
OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. OS was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.
time origin
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0004
source section id
NCT02256436-om-0004
source outcome index
4
endpoint
PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors
endpoint definition
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.
time origin
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0005
source section id
NCT02256436-om-0005
source outcome index
5
endpoint
OS - Participants With Strongly PD-L1 Positive Tumors
endpoint definition
OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with a PD-L1 CPS ≥10% were considered to have a strongly PD-L1 positive tumor status. The OS was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.
time origin
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0000
arm key
OG000
arm label
Control
regimen
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
analyzed count
272
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0000
arm key
OG001
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
analyzed count
270
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0001
arm key
OG000
arm label
Control
regimen
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
analyzed count
272
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0001
arm key
OG001
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
analyzed count
270
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0002
arm key
OG000
arm label
Control
regimen
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
analyzed count
120
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0002
arm key
OG001
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
analyzed count
110
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0003
arm key
OG000
arm label
Control
regimen
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
analyzed count
120
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0003
arm key
OG001
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
analyzed count
110
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0004
arm key
OG000
arm label
Control
regimen
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
analyzed count
90
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0004
arm key
OG001
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
analyzed count
74
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0005
arm key
OG000
arm label
Control
regimen
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
analyzed count
90
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
outcome key
om-0005
arm key
OG001
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
analyzed count
74
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02256436-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
harm key
EG000
source section id
NCT02256436-ae
event group key
EG000
event group label
Control
serious affected
104
serious at risk
255
other affected
237
other at risk
255
frequency threshold
5
collection period
Through end of trial analysis database cut-off date of 01-Oct-2020 (Up to approximately 71 months)
event definition
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. Thirteen participants randomized to receive Control were switched over to pembrolizumab per protocol and were monitored for AEs separately.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
harm key
EG001
source section id
NCT02256436-ae
event group key
EG001
event group label
Pembrolizumab
serious affected
107
serious at risk
266
other affected
236
other at risk
266
frequency threshold
5
collection period
Through end of trial analysis database cut-off date of 01-Oct-2020 (Up to approximately 71 months)
event definition
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. Thirteen participants randomized to receive Control were switched over to pembrolizumab per protocol and were monitored for AEs separately.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02256436
harm key
EG002
source section id
NCT02256436-ae
event group key
EG002
event group label
Control Switched Over to Pembrolizumab
serious affected
8
serious at risk
13
other affected
11
other at risk
13
frequency threshold
5
collection period
Through end of trial analysis database cut-off date of 01-Oct-2020 (Up to approximately 71 months)
event definition
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. Thirteen participants randomized to receive Control were switched over to pembrolizumab per protocol and were monitored for AEs separately.
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

setting source links

Preserved source evidence · Not medical advice