Trial · NCT02853305
Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
NCT02853305, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361). Trials, record NCT02853305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02853305
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
- NCT number
- NCT02853305
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,010 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Urothelial Carcinoma Associated 1 RNA, Human
- Interventions
- Pembrolizumab, Cisplatin, Carboplatin, Gemcitabine
- First posted
- 2016-08-02
- Last updated
- 2023-09-08
- Other registries' IDs
- eudract:2015-005731-41
- Results first posted
- 2021-05-20
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | Up to approximately 42 months | 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. |
| Primary | Pembro Combo vs Chemo: Overall Survival (OS) | Up to approximately 42 months | 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 | Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10% | Up to approximately 42 months | 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. |
| Primary | Pembro vs Chemo: OS | Up to approximately 42 months | 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. |
| Secondary | Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | 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. |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 55 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. 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. |
| Secondary | Number of Participants Who Discontinue Study Drug Due to an AE | Up to approximately 52 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. 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 discontinued any study drug due to an AE was reported for each treatment arm. |
| Secondary | Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 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: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record. |
| Secondary | Pembro Combo vs Chemo: Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro arm and chemo arm and is presented later in the record. |
| Secondary | Pembro Combo vs Chemo: Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | DCR was defined as the percentage of participants who had a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD \[at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD\]). Per protocol, DCR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro combo arm and chemo arm. Per protocol, DCR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record. |
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 | 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) | Up to approximately 42 months | 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. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs Chemo: Overall Survival (OS) | Up to approximately 42 months | 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. | Months | MEDIAN |
| PRIMARY | Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10% | Up to approximately 42 months | 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. | Months | MEDIAN |
| PRIMARY | Pembro vs Chemo: OS | Up to approximately 42 months | 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. | Months | MEDIAN |
| SECONDARY | Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | 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. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 55 months | All randomized participants who received at least 1 dose of trial treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinue Study Drug Due to an AE | Up to approximately 52 months | All randomized participants who received at least 1 dose of trial treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Pembro Combo vs Chemo: Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro combo arm and chemo arm and who demonstrated a confirmed CR or PR were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro Combo vs Chemo: Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | 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. | Percentage of Participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Pembrolizumab + ST Chemotherapy (Pembro Combo) | 8.3 | 95% Confidence Interval 7.5 to 8.5 | Months | |
| 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) | ST Chemotherapy (Chemo) | 7.1 | 95% Confidence Interval 6.4 to 7.9 | Months | |
| Pembro Combo vs Chemo: Overall Survival (OS) | Pembrolizumab + ST Chemotherapy (Pembro Combo) | 17.0 | 95% Confidence Interval 14.5 to 19.5 | Months | |
| Pembro Combo vs Chemo: Overall Survival (OS) | ST Chemotherapy (Chemo) | 14.3 | 95% Confidence Interval 12.3 to 16.7 | Months | |
| Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10% | Pembrolizumab (Pembro) | 16.1 | 95% Confidence Interval 13.6 to 19.9 | Months | |
| Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10% | ST Chemotherapy (Chemo) | 15.2 | 95% Confidence Interval 11.6 to 23.3 | Months | |
| Pembro vs Chemo: OS | Pembrolizumab (Pembro) | 15.6 | 95% Confidence Interval 12.1 to 17.9 | Months | |
| Pembro vs Chemo: OS | ST Chemotherapy (Chemo) | 14.3 | 95% Confidence Interval 12.3 to 16.7 | Months | |
| Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR | Pembrolizumab (Pembro) | 3.9 | 95% Confidence Interval 2.3 to 5.1 | Months | |
| Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR | ST Chemotherapy (Chemo) | 7.1 | 95% Confidence Interval 6.4 to 7.9 | Months |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab + ST Chemotherapy (Pembro Combo) | 351 | |
| Overall Study | STARTED | Pembrolizumab (Pembro) | 307 | |
| Overall Study | STARTED | ST Chemotherapy (Chemo) | 352 | |
| Overall Study | Received First Course of Pembrolizumab | Pembrolizumab + ST Chemotherapy (Pembro Combo) | 349 | |
| Overall Study | Received First Course of Pembrolizumab | Pembrolizumab (Pembro) | 302 | |
| Overall Study | Received First Course of Pembrolizumab | ST Chemotherapy (Chemo) | 342 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab + ST Chemotherapy (Pembro Combo) | 14 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab (Pembro) | 15 | |
| Overall Study | Received Second Course of Pembrolizumab | ST Chemotherapy (Chemo) | 0 | |
| Overall Study | COMPLETED | Pembrolizumab + ST Chemotherapy (Pembro Combo) | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,750
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 + ST Chemotherapy (Pembro Combo) First Course | 227 | 349 | 334 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab (Pembro) First Course | 75 | 302 | 103 |
| other | Anaemia | Blood and lymphatic system disorders | ST Chemotherapy (Chemo) First Course | 210 | 342 | 303 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course | 0 | 14 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab (Pembro) Second Course | 0 | 15 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course | 31 | 349 | 60 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab (Pembro) First Course | 0 | 302 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | ST Chemotherapy (Chemo) First Course | 25 | 342 | 55 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course | 0 | 14 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab (Pembro) Second Course | 0 | 15 | 0 |
1 to 10 of 1,750Source ClinicalTrials.gov
See all 1,750 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course | 283 | 351 |
| Total, all-cause mortality | Pembrolizumab (Pembro) First Course | 244 | 307 |
| Total, all-cause mortality | ST Chemotherapy (Chemo) First Course | 300 | 352 |
| Total, all-cause mortality | Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course | 4 | 14 |
| Total, all-cause mortality | Pembrolizumab (Pembro) Second Course | 8 | 15 |
| Total, other adverse events | Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course | 345 | 349 |
| Total, other adverse events | Pembrolizumab (Pembro) First Course | 275 | 302 |
| Total, other adverse events | ST Chemotherapy (Chemo) First Course | 337 | 342 |
| Total, other adverse events | Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course | 0 | 14 |
| Total, other adverse events | Pembrolizumab (Pembro) Second Course | 1 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT02853305/results?page=2