Trial · NCT02335424
Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052)
NCT02335424, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2019-07-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052). Trials, record NCT02335424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02335424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052)
- NCT number
- NCT02335424
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 374 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Urothelial Cancer
- Interventions
- pembrolizumab
- First posted
- 2015-01-09
- Last updated
- 2023-03-02
- Other registries' IDs
- eudract:2014-002206-20
- Results first posted
- 2019-07-05
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Up to approximately 80.5 months | 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. |
| Primary | 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% | Up to approximately 80.5 months | 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. |
| Primary | 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% | Up to approximately 80.5 months | 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. |
| Secondary | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Up to approximately 80.5 months | 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. |
| Secondary | 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% | Up to approximately 80.5 months | 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. |
| Secondary | 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% | Up to approximately 80.5 months | 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. |
| Secondary | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Up to approximately 80.5 months | PFS was determined in all participants. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). 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. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis. |
| Secondary | Progression Free Survival (PFS) 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% | Up to approximately 80.5 months | PFS was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). 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. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis. |
| Secondary | Progression Free Survival (PFS) 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% | Up to approximately 80.5 months | PFS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). 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. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis. |
| Secondary | Overall Survival (OS) in All Participants | Up to approximately 80.5 months | OS was determined for all participants and was defined as the time from randomization to death due to any cause. OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Up to approximately 80.5 months | All participants who received at least one dose of study treatment during the initial course of treatment | Percentage of participants | NUMBER |
| PRIMARY | 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% | Up to approximately 80.5 months | 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 | Percentage of participants | NUMBER |
| PRIMARY | 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% | Up to approximately 80.5 months | 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 | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Up to approximately 80.5 months | 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. | Months | MEDIAN |
| SECONDARY | 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% | Up to approximately 80.5 months | 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. | Months | MEDIAN |
| SECONDARY | 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% | Up to approximately 80.5 months | 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. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Up to approximately 80.5 months | All participants who received at least one dose of study treatment during the initial course of treatment. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) 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% | Up to approximately 80.5 months | 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. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) 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% | Up to approximately 80.5 months | 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. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in All Participants | Up to approximately 80.5 months | All participants who received at least one dose of study treatment during the initial course of treatment | Months | MEDIAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Pembrolizumab 200 mg | 28.9 | 95% Confidence Interval 24.3 to 33.8 | Percentage of participants | |
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% | Pembrolizumab 200 mg | 32.6 | 95% Confidence Interval 27.2 to 38.4 | Percentage of participants | |
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% | Pembrolizumab 200 mg | 47.3 | 95% Confidence Interval 37.7 to 57.0 | Percentage of participants | |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Pembrolizumab 200 mg | 33.4 | 95% Confidence Interval 18.2 to 48.7 | Months | |
| 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% | Pembrolizumab 200 mg | 35.8 | 95% Confidence Interval 20.4 to NA | Months | |
| 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% | Pembrolizumab 200 mg | NA | 95% Confidence Interval 18.1 to NA | Months | |
| Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Pembrolizumab 200 mg | 2.5 | 95% Confidence Interval 2.1 to 3.4 | Months | |
Progression Free Survival (PFS) 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% | Pembrolizumab 200 mg | 3.4 | 95% Confidence Interval 2.3 to 4.0 | Months | |
Progression Free Survival (PFS) 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% | Pembrolizumab 200 mg | 4.9 | 95% Confidence Interval 3.8 to 10.8 | Months | |
| Overall Survival (OS) in All Participants | Pembrolizumab 200 mg | 11.3 | 95% Confidence Interval 9.7 to 13.1 | Months |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab 200 mg | 374 | |
| Overall Study | Treated | Pembrolizumab 200 mg | 370 | |
| Overall Study | Received Second Course Treatment | Pembrolizumab 200 mg | 13 | |
| Overall Study | COMPLETED | Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab 200 mg | 374 |
Source ClinicalTrials.gov
Adverse events434
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab | 73 | 370 | 84 |
| other | Anaemia | Blood and lymphatic system disorders | Second Course Pembrolizumab | 3 | 13 | 3 |
| other | Ear swelling | Ear and labyrinth disorders | Pembrolizumab | 0 | 370 | 0 |
| other | Ear swelling | Ear and labyrinth disorders | Second Course Pembrolizumab | 1 | 13 | 1 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab | 42 | 370 | 42 |
| other | Hypothyroidism | Endocrine disorders | Second Course Pembrolizumab | 1 | 13 | 1 |
| other | Diplopia | Eye disorders | Pembrolizumab | 0 | 370 | 0 |
| other | Diplopia | Eye disorders | Second Course Pembrolizumab | 1 | 13 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab | 47 | 370 | 57 |
| other | Abdominal pain | Gastrointestinal disorders | Second Course Pembrolizumab | 1 | 13 | 1 |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab | 305 | 374 |
| Total, all-cause mortality | Second Course Pembrolizumab | 8 | 13 |
| Total, other adverse events | Pembrolizumab | 342 | 370 |
| Total, other adverse events | Second Course Pembrolizumab | 12 | 13 |
| Total, serious adverse events | Pembrolizumab | 190 | 370 |
| Total, serious adverse events | Second Course Pembrolizumab | 6 | 13 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab vs Second Course Pembrolizumab: deaths from any cause | Trial comparisons |
| Pembrolizumab vs Second Course Pembrolizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02335424
GET https://conductscience.org/api/trials/v1/NCT02335424/registered?page=2