Trial · NCT02819518
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)
NCT02819518, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2022-07-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355). Trials, record NCT02819518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02819518
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)
- NCT number
- NCT02819518
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 882 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Interventions
- Pembrolizumab, Nab-paclitaxel, Paclitaxel, Gemcitabine, Carboplatin, Normale Saline Solution
- First posted
- 2016-06-30
- Last updated
- 2024-11-27
- Other registries' IDs
- eudract:2016-001432-35
- Results first posted
- 2022-07-05
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants | Up to approximately 39 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Primary | Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants | Up to approximately 39 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Primary | Part 2: Progression-Free Survival (PFS) - All Participants | Up to approximately 53 months | Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs 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 must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. |
| Primary | Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors | Up to approximately 53 months | Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs 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 must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. |
| Primary | Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors | Up to approximately 53 months | Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs 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 must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. |
| Primary | Part 2: Overall Survival (OS) - All Participants | Up to approximately 53 months | Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. |
| Primary | Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors | Up to approximately 53 months | Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. |
| Primary | Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors | Up to approximately 53 months | Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. |
| Secondary | Part 2: Objective Response Rate (ORR) - All Participants | Up to approximately 53 months | Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented. |
| Secondary | Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors | Up to approximately 53 months | Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants | Up to approximately 39 months | All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin. | Percentage of Participants | NUMBER |
| PRIMARY | Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants | Up to approximately 39 months | All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin. | Percentage of Participants | NUMBER |
| PRIMARY | Part 2: Progression-Free Survival (PFS) - All Participants | Up to approximately 53 months | Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Months | MEDIAN |
| PRIMARY | Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors | Up to approximately 53 months | Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Months | MEDIAN |
| PRIMARY | Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors | Up to approximately 53 months | Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Months | MEDIAN |
| PRIMARY | Part 2: Overall Survival (OS) - All Participants | Up to approximately 53 months | Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Months | MEDIAN |
| PRIMARY | Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors | Up to approximately 53 months | Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Months | MEDIAN |
| PRIMARY | Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors | Up to approximately 53 months | Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Months | MEDIAN |
| SECONDARY | Part 2: Objective Response Rate (ORR) - All Participants | Up to approximately 53 months | Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Percentage of Participants | NUMBER |
| SECONDARY | Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors | Up to approximately 53 months | Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment | Percentage of Participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants | Part 1: Pembrolizumab + Nab-Paclitaxel | 100.0 | Percentage of Participants | ||
| Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants | Part 1: Pembrolizumab + Paclitaxel | 100.0 | Percentage of Participants | ||
| Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 100.0 | Percentage of Participants | ||
| Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants | Part 1: Pembrolizumab + Nab-Paclitaxel | 38.5 | Percentage of Participants | ||
| Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants | Part 1: Pembrolizumab + Paclitaxel | 50.0 | Percentage of Participants | ||
| Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 27.3 | Percentage of Participants | ||
| Part 2: Progression-Free Survival (PFS) - All Participants | Part 2: Pembrolizumab + Chemotherapy | 7.5 | 95% Confidence Interval 6.3 to 7.7 | Months | |
| Part 2: Progression-Free Survival (PFS) - All Participants | Part 2: Placebo + Chemotherapy | 5.6 | 95% Confidence Interval 5.4 to 7.2 | Months | |
| Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors | Part 2: Pembrolizumab + Chemotherapy | 7.6 | 95% Confidence Interval 6.6 to 8.0 | Months | |
| Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors | Part 2: Placebo + Chemotherapy | 5.6 | 95% Confidence Interval 5.4 to 7.4 | Months |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Pembrolizumab + Nab-Paclitaxel | 11 | |
| Overall Study | STARTED | Part 1: Pembrolizumab + Paclitaxel | 14 | |
| Overall Study | STARTED | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 10 | |
| Overall Study | STARTED | Part 2: Pembrolizumab + Chemotherapy | 566 | |
| Overall Study | STARTED | Part 2: Placebo + Chemotherapy | 281 | |
| Overall Study | Treated | Part 1: Pembrolizumab + Nab-Paclitaxel | 13 | |
| Overall Study | Treated | Part 1: Pembrolizumab + Paclitaxel | 10 | |
| Overall Study | Treated | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 11 | |
| Overall Study | Treated | Part 2: Pembrolizumab + Chemotherapy | 562 | |
| Overall Study | Treated | Part 2: Placebo + Chemotherapy | 281 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events2,520
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 | Part 1: Pembrolizumab + Nab-Paclitaxel | 5 | 13 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Pembrolizumab + Paclitaxel | 5 | 10 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 8 | 11 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Pembrolizumab + Chemotherapy (First Course) | 294 | 562 | 633 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Pembrolizumab + Chemotherapy (Second Course) | 4 | 12 | 22 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Placebo + Chemotherapy | 140 | 281 | 258 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 1: Pembrolizumab + Nab-Paclitaxel | 0 | 13 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 1: Pembrolizumab + Paclitaxel | 0 | 10 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 2 | 11 | 64 |
| other | Leukopenia | Blood and lymphatic system disorders | Part 2: Pembrolizumab + Chemotherapy (First Course) | 111 | 562 | 461 |
1 to 10 of 2,520Source ClinicalTrials.gov
See all 2,520 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Pembrolizumab + Nab-Paclitaxel | 9 | 11 |
| Total, all-cause mortality | Part 1: Pembrolizumab + Paclitaxel | 12 | 14 |
| Total, all-cause mortality | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 9 | 10 |
| Total, all-cause mortality | Part 2: Pembrolizumab + Chemotherapy (First Course) | 484 | 566 |
| Total, all-cause mortality | Part 2: Pembrolizumab + Chemotherapy (Second Course) | 5 | 12 |
| Total, all-cause mortality | Part 2: Placebo + Chemotherapy | 249 | 281 |
| Total, other adverse events | Part 1: Pembrolizumab + Nab-Paclitaxel | 13 | 13 |
| Total, other adverse events | Part 1: Pembrolizumab + Paclitaxel | 10 | 10 |
| Total, other adverse events | Part 1: Pembrolizumab + Gemcitabine/Carboplatin | 11 | 11 |
| Total, other adverse events | Part 2: Pembrolizumab + Chemotherapy (First Course) | 551 | 562 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02819518
GET https://conductscience.org/api/trials/v1/NCT02819518/registered?page=2