Trial · NCT02256436
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)
NCT02256436, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2017-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045). Trials, record NCT02256436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02256436
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)
- NCT number
- NCT02256436
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 542 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Urothelial Cancer
- Interventions
- pembrolizumab, paclitaxel, vinflunine, docetaxel
- First posted
- 2014-10-03
- Last updated
- 2021-09-20
- Other registries' IDs
- eudract:2014-002009-40
- Results first posted
- 2017-08-31
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. |
| Primary | Overall Survival (OS) - All Participants | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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 | PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. |
| Primary | OS - Participants With PD-L1 Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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 | PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. |
| Primary | OS - Participants With Strongly PD-L1 Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | 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. Participants were monitored for the occurrence nonserious AEs for up to 30 days after last dose of study treatment and for serious AEs for up to 90 days after last dose of study treatment. The number of participants who experienced an AE was reported for each arm. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | 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. Participants were monitored for the occurrence nonserious AEs for up to 30 days after last dose of study treatment and for serious AEs for up to 90 days after last dose of study treatment. The number of participants who discontinued study treatment due to an AE was reported for each arm. |
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | ORR was defined as the percentage of participants in the analysis population who had a 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. ORR was assessed by BICR in participants with strongly PD-L1 positive tumors (CPS ≥10%) up through the final analysis database cut-off date of 26-Oct-2017. |
| Secondary | ORR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by BICR in participants with PD-L1 positive tumors (CPS ≥1%) up through the final analysis database cut-off date of 26-Oct-2017. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) - All Participants | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. | Months | MEDIAN |
| PRIMARY | PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. | Months | MEDIAN |
| PRIMARY | OS - Participants With PD-L1 Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. | Months | MEDIAN |
| PRIMARY | PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. | Months | MEDIAN |
| PRIMARY | OS - Participants With Strongly PD-L1 Positive Tumors | Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) | 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. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. | Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | 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. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors | Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months) | 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. | Percentage of Participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants | Control | 3.3 | 95% Confidence Interval 2.3 to 3.5 | Months | |
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants | Pembrolizumab | 2.1 | 95% Confidence Interval 2.0 to 2.2 | Months | |
| Overall Survival (OS) - All Participants | Control | 7.4 | 95% Confidence Interval 5.1 | Months | |
| Overall Survival (OS) - All Participants | Pembrolizumab | 10.3 | 95% Confidence Interval 37.8 | Months | |
| PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors | Control | 3.2 | 95% Confidence Interval 2.2 to 3.4 | Months | |
| PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors | Pembrolizumab | 2.1 | 95% Confidence Interval 2.0 to 2.4 | Months | |
| OS - Participants With PD-L1 Positive Tumors | Control | 6.9 | 95% Confidence Interval 4.7 to 8.8 | Months | |
| OS - Participants With PD-L1 Positive Tumors | Pembrolizumab | 11.3 | 95% Confidence Interval 7.7 to 16.0 | Months | |
| PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors | Control | 3.1 | 95% Confidence Interval 2.2 to 3.4 | Months | |
| PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors | Pembrolizumab | 2.1 | 95% Confidence Interval 1.9 to 2.1 | Months |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 272 | |
| Overall Study | STARTED | Pembrolizumab | 270 | |
| Overall Study | Treated | Control | 255 | |
| Overall Study | Treated | Pembrolizumab | 266 | |
| Overall Study | Switched Over to Pembrolizumab | Control | 13 | |
| Overall Study | Switched Over to Pembrolizumab | Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Control | 0 | |
| Overall Study | COMPLETED | Pembrolizumab | 0 | |
| Overall Study | NOT COMPLETED | Control | 272 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 270 |
Source ClinicalTrials.gov
Adverse events741
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 | Control | 86 | 255 | 139 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab | 45 | 266 | 61 |
| other | Anaemia | Blood and lymphatic system disorders | Control Switched Over to Pembrolizumab | 1 | 13 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Control | 41 | 255 | 74 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab | 0 | 266 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Control Switched Over to Pembrolizumab | 0 | 13 | 0 |
| other | Hyperthyroidism | Endocrine disorders | Control | 0 | 255 | 0 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab | 11 | 266 | 11 |
| other | Hyperthyroidism | Endocrine disorders | Control Switched Over to Pembrolizumab | 1 | 13 | 1 |
| other | Hypothyroidism | Endocrine disorders | Control | 3 | 255 | 3 |
1 to 10 of 741Source ClinicalTrials.gov
See all 741 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | 230 | 272 |
| Total, all-cause mortality | Pembrolizumab | 224 | 270 |
| Total, all-cause mortality | Control Switched Over to Pembrolizumab | 9 | 13 |
| Total, other adverse events | Control | 237 | 255 |
| Total, other adverse events | Pembrolizumab | 236 | 266 |
| Total, other adverse events | Control Switched Over to Pembrolizumab | 11 | 13 |
| Total, serious adverse events | Control | 104 | 255 |
| Total, serious adverse events | Pembrolizumab | 107 | 266 |
| Total, serious adverse events | Control Switched Over to Pembrolizumab | 8 | 13 |
Source ClinicalTrials.gov
Papers10
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 Control: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| Pembrolizumab vs Control: Number of Participants Who Discontinued Study Treatment Due to an AE | 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/NCT02256436
GET https://conductscience.org/api/trials/v1/NCT02256436/results?page=2