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

NCT02853305 · STUDY IN CONTEXT

Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)

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 progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population (all randomized participants). PFS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.

All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the CPS ≥10% subset of the pembro arm was compared to OS in the CPS ≥10% subset of the chemo arm for this endpoint as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro arm and chemo arm who were PD-L1 CPS ≥10%. Per protocol, OS in the CPS ≥10% subset of the pembro combo arm was not a pre-specified analysis of the ITT population and is not presented.

All participants in the ITT population randomized to the pembro arm and chemo arm who were PD-L1 CPS ≥10% were included in the analysis. Per protocol, the pembro combo arm was not pre-specified as part of this analysis and is not included.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.

All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.

→

secondary · POSTED

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS in the pembro arm was compared to the chemo arm as a pre-specified analysis of the ITT population (all randomized participants). PFS is reported here for all participants in the pembro arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.

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secondary · POSTED

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.

All randomized participants who received at least 1 dose of trial treatment were analyzed.

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Reported safety

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

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score

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: NCT02853305
qol key: qol-0016
source section id: NCT02853305-om-0016
source outcome index: 16
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
measure definition: The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
time frame: Baseline, Week 18
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score indicating a better
population note: All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score

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: NCT02853305
qol key: qol-0017
source section id: NCT02853305-om-0017
source outcome index: 17
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
measure definition: EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro combo arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro arm and chemo arm and is presented later in the record.
time frame: Baseline up to approximately 25 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score indicating a better
population note: All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score

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: NCT02853305
qol key: qol-0018
source section id: NCT02853305-om-0018
source outcome index: 18
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score
measure definition: The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
time frame: Baseline, Week 18
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score indicating a better
population note: All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score

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: NCT02853305
qol key: qol-0019
source section id: NCT02853305-om-0019
source outcome index: 19
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
measure definition: EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro combo arm and chemo arm and is presented earlier in the record.
time frame: Baseline up to approximately 25 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score indicating a better
population note: All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis.
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: NCT02853305
trial label: Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
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: 5
qol Count: 4

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0000
source section id
NCT02853305-om-0000
source outcome index
0
endpoint
Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
endpoint definition
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population (all randomized participants). PFS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
time origin
Up to approximately 42 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0001
source section id
NCT02853305-om-0001
source outcome index
1
endpoint
Pembro Combo vs Chemo: Overall Survival (OS)
endpoint definition
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
time origin
Up to approximately 42 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0002
source section id
NCT02853305-om-0002
source outcome index
2
endpoint
Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10%
endpoint definition
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the CPS ≥10% subset of the pembro arm was compared to OS in the CPS ≥10% subset of the chemo arm for this endpoint as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro arm and chemo arm who were PD-L1 CPS ≥10%. Per protocol, OS in the CPS ≥10% subset of the pembro combo arm was not a pre-specified analysis of the ITT population and is not presented.
time origin
Up to approximately 42 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants in the ITT population randomized to the pembro arm and chemo arm who were PD-L1 CPS ≥10% were included in the analysis. Per protocol, the pembro combo arm was not pre-specified as part of this analysis and is not included.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0003
source section id
NCT02853305-om-0003
source outcome index
3
endpoint
Pembro vs Chemo: OS
endpoint definition
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
time origin
Up to approximately 42 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0004
source section id
NCT02853305-om-0004
source outcome index
4
endpoint
Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR
endpoint definition
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS in the pembro arm was compared to the chemo arm as a pre-specified analysis of the ITT population (all randomized participants). PFS is reported here for all participants in the pembro arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
time origin
Up to approximately 42 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0005
source section id
NCT02853305-om-0005
source outcome index
5
endpoint
Number of Participants Who Experience an Adverse Event (AE)
endpoint definition
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
time origin
Up to approximately 55 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants who received at least 1 dose of trial treatment were analyzed.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0000
arm key
OG000
arm label
Pembrolizumab + ST Chemotherapy (Pembro Combo)
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
351
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0000
arm key
OG001
arm label
Pembrolizumab (Pembro)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0000
arm key
OG002
arm label
ST Chemotherapy (Chemo)
regimen
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
352
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0001
arm key
OG000
arm label
Pembrolizumab + ST Chemotherapy (Pembro Combo)
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
351
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0001
arm key
OG001
arm label
Pembrolizumab (Pembro)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0001
arm key
OG002
arm label
ST Chemotherapy (Chemo)
regimen
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
352
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0002
arm key
OG000
arm label
Pembrolizumab + ST Chemotherapy (Pembro Combo)
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0002
arm key
OG001
arm label
Pembrolizumab (Pembro)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
analyzed count
160
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0002
arm key
OG002
arm label
ST Chemotherapy (Chemo)
regimen
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
158
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0003
arm key
OG000
arm label
Pembrolizumab + ST Chemotherapy (Pembro Combo)
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0003
arm key
OG001
arm label
Pembrolizumab (Pembro)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
analyzed count
307
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
outcome key
om-0003
arm key
OG002
arm label
ST Chemotherapy (Chemo)
regimen
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
analyzed count
352
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02853305-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
harm key
EG000
source section id
NCT02853305-ae
event group key
EG000
event group label
Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course
serious affected
189
serious at risk
349
other affected
345
other at risk
349
frequency threshold
5
collection period
Up to approximately 70 months
event definition
All-Cause Mortality reported for all randomized participants by course. 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.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
harm key
EG001
source section id
NCT02853305-ae
event group key
EG001
event group label
Pembrolizumab (Pembro) First Course
serious affected
145
serious at risk
302
other affected
275
other at risk
302
frequency threshold
5
collection period
Up to approximately 70 months
event definition
All-Cause Mortality reported for all randomized participants by course. 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.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
harm key
EG002
source section id
NCT02853305-ae
event group key
EG002
event group label
ST Chemotherapy (Chemo) First Course
serious affected
138
serious at risk
342
other affected
337
other at risk
342
frequency threshold
5
collection period
Up to approximately 70 months
event definition
All-Cause Mortality reported for all randomized participants by course. 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.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
harm key
EG003
source section id
NCT02853305-ae
event group key
EG003
event group label
Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course
serious affected
0
serious at risk
14
other affected
0
other at risk
14
frequency threshold
5
collection period
Up to approximately 70 months
event definition
All-Cause Mortality reported for all randomized participants by course. 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.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
harm key
EG004
source section id
NCT02853305-ae
event group key
EG004
event group label
Pembrolizumab (Pembro) Second Course
serious affected
0
serious at risk
15
other affected
1
other at risk
15
frequency threshold
5
collection period
Up to approximately 70 months
event definition
All-Cause Mortality reported for all randomized participants by course. 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.
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

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
nct id
NCT02853305
qol key
qol-0016
source section id
NCT02853305-om-0016
source outcome index
16
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
measure definition
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
time frame
Baseline, Week 18
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating a better
population note
All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
qol key
qol-0017
source section id
NCT02853305-om-0017
source outcome index
17
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
measure definition
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro combo arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro arm and chemo arm and is presented later in the record.
time frame
Baseline up to approximately 25 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating a better
population note
All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
qol key
qol-0018
source section id
NCT02853305-om-0018
source outcome index
18
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score
measure definition
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
time frame
Baseline, Week 18
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating a better
population note
All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis.
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-keytruda-qlex-6b2249a8
nct id
NCT02853305
qol key
qol-0019
source section id
NCT02853305-om-0019
source outcome index
19
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
measure definition
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro combo arm and chemo arm and is presented earlier in the record.
time frame
Baseline up to approximately 25 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating a better
population note
All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis.
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