TriangleNCT02335424 · STUDY IN CONTEXT
Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052)
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
ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
DOR was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
DOR was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Reported safety
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-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- trial label
- Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052)
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- outcome key
- om-0000
- source section id
- NCT02335424-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
- endpoint definition
- ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
- time origin
- Up to approximately 80.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of study treatment during the initial course of treatment
- 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
- NCT02335424
- outcome key
- om-0001
- source section id
- NCT02335424-om-0001
- source outcome index
- 1
- endpoint
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
- endpoint definition
- ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
- time origin
- Up to approximately 80.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS
- 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
- NCT02335424
- outcome key
- om-0002
- source section id
- NCT02335424-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
- endpoint definition
- ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
- time origin
- Up to approximately 80.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS
- 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
- NCT02335424
- outcome key
- om-0003
- source section id
- NCT02335424-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
- endpoint definition
- DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
- time origin
- Up to approximately 80.5 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of study treatment, during the initial course of treatment, and who had a confirmed CR or confirmed PR.
- 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
- NCT02335424
- outcome key
- om-0004
- source section id
- NCT02335424-om-0004
- source outcome index
- 4
- endpoint
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
- endpoint definition
- DOR was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
- time origin
- Up to approximately 80.5 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of study treatment during the initial course of treatment, had a PD-L1 positive expression of ≥1% CPS, and who had a confirmed CR or PR.
- 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
- NCT02335424
- outcome key
- om-0005
- source section id
- NCT02335424-om-0005
- source outcome index
- 5
- endpoint
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
- endpoint definition
- DOR was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
- time origin
- Up to approximately 80.5 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of study treatment during the initial course of treatment, had a PD-L1 strong positive expression of ≥10% CPS, and who had a confirmed CR or PR.
- 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
- NCT02335424
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
- analyzed count
- 370
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02335424-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
- analyzed count
- 282
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02335424-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
- analyzed count
- 110
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02335424-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
- analyzed count
- 107
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02335424-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02335424-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02335424-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-qlex-6b2249a8
- nct id
- NCT02335424
- harm key
- EG000
- source section id
- NCT02335424-ae
- event group key
- EG000
- event group label
- Pembrolizumab
- serious affected
- 190
- serious at risk
- 370
- other affected
- 342
- other at risk
- 370
- frequency threshold
- 5
- collection period
- Up to approximately 80.5 months
- event definition
- Adverse events=all participants who received ≥1 dose of study treatment; all-cause mortality=all allocated participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study drug are 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
- NCT02335424
- harm key
- EG001
- source section id
- NCT02335424-ae
- event group key
- EG001
- event group label
- Second Course Pembrolizumab
- serious affected
- 6
- serious at risk
- 13
- other affected
- 12
- other at risk
- 13
- frequency threshold
- 5
- collection period
- Up to approximately 80.5 months
- event definition
- Adverse events=all participants who received ≥1 dose of study treatment; all-cause mortality=all allocated participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study drug are 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
- setting source links
Preserved source evidence · Not medical advice