Trial · NCT04191135
Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)
NCT04191135, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2024-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009). Trials, record NCT04191135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04191135
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)
- NCT number
- NCT04191135
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 462 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Pembrolizumab, Olaparib, Carboplatin, Gemcitabine
- First posted
- 2019-12-09
- Last updated
- 2026-09-14
- Other registries' IDs
- eudract:2019-001892-35
- Results first posted
- 2024-02-14
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to approximately 29 months | PFS 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) as Assessed 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 (SOD) 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. PFS is reported based on the product-limit (Kaplan-Meier) method for censored data. |
| Primary | Overall Survival (OS) | Up to approximately 29 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. OS is reported based on the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10 | Up to approximately 29 months | PFS 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) as Assessed 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 (SOD) 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. Only participants with a CPS ≥10 were included in this analysis. PFS is reported based on the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10 | Up to approximately 29 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. Only participants with a CPS ≥10 were included in this analysis. |
| Secondary | PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors | Up to approximately 29 months | PFS 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) as Assessed 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 (SOD) 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. Only participants with BRCAm-positive tumors were included in this analysis. PFS is reported based on the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | OS in Participants With BRCAm Tumors | Up to approximately 29 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. Only participants with BRCAm-positive tumors were included in this analysis. |
| Secondary | Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Combined Score | Baseline and week 18 | EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates. |
| Secondary | Change From Baseline in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score | Baseline and week 18 | EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates. |
| Secondary | Change From Baseline in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score | Baseline and week 18 | EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 4 questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in emotional functioning (EORTC QLQ-C30 Items 21-24) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates. |
| Secondary | Change From Baseline in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific QoL Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score | Baseline and week 18 | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30, consisting of functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All, 4=Very Much). Using linear transformation, raw scores are standardized, so scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
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) | Up to approximately 29 months | The analysis population included all randomized participants | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 29 months | The analysis population included all randomized participants | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10 | Up to approximately 29 months | The analysis populations included all randomized participants with a CPS ≥10 | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10 | Up to approximately 29 months | The analysis population included all randomized participants with a CPS ≥10 | Months | MEDIAN |
| SECONDARY | PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors | Up to approximately 29 months | The analysis population included all randomized participants with BRCAm tumors | Months | MEDIAN |
| SECONDARY | OS in Participants With BRCAm Tumors | Up to approximately 29 months | The analysis population included all randomized participants with BRCAm tumors | Months | MEDIAN |
| SECONDARY | Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Combined Score | Baseline and week 18 | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score | Baseline and week 18 | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score | Baseline and week 18 | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific QoL Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score | Baseline and week 18 | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Score on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group52
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) | Pembrolizumab + Olaparib | 5.5 | 95% Confidence Interval 4.2 to 8.3 | Months | |
| Progression-Free Survival (PFS) | Pembrolizumab + Carboplatin + Gemcitabine | 5.6 | 95% Confidence Interval 4.3 to 6.9 | Months | |
| Overall Survival (OS) | Pembrolizumab + Olaparib | 25.1 | 95% Confidence Interval 18.3 to NA | Months | |
| Overall Survival (OS) | Pembrolizumab + Carboplatin + Gemcitabine | 23.4 | 95% Confidence Interval 15.8 to NA | Months | |
| Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10 | Pembrolizumab + Olaparib | 5.7 | 95% Confidence Interval 2.9 to 13.9 | Months | |
| Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10 | Pembrolizumab + Carboplatin + Gemcitabine | 5.7 | 95% Confidence Interval 3.8 to 7.6 | Months | |
| Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10 | Pembrolizumab + Olaparib | NA | 95% Confidence Interval 17.0 to NA | Months | |
| Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10 | Pembrolizumab + Carboplatin + Gemcitabine | NA | 95% Confidence Interval 15.5 to NA | Months | |
| PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors | Pembrolizumab + Olaparib | 12.4 | 95% Confidence Interval 8.3 to NA | Months | |
| PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors | Pembrolizumab + Carboplatin + Gemcitabine | 8.4 | 95% Confidence Interval 5.4 to NA | Months |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Treatment | STARTED | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 462 | |
| Induction Treatment | STARTED | Pembrolizumab + Olaparib | 0 | |
| Induction Treatment | STARTED | Pembrolizumab + Carboplatin + Gemcitabine | 0 | |
| Induction Treatment | Treated | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 460 | |
| Induction Treatment | Treated | Pembrolizumab + Olaparib | 0 | |
| Induction Treatment | Treated | Pembrolizumab + Carboplatin + Gemcitabine | 0 | |
| Induction Treatment | COMPLETED | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 0 | |
| Induction Treatment | COMPLETED | Pembrolizumab + Olaparib | 0 | |
| Induction Treatment | COMPLETED | Pembrolizumab + Carboplatin + Gemcitabine | 0 | |
| Induction Treatment | NOT COMPLETED | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 462 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events489
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 + Carboplatin + Gemcitabine Induction Treatment | 274 | 460 | 361 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Olaparib | 54 | 135 | 75 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Carboplatin + Gemcitabine | 69 | 133 | 121 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 84 | 460 | 179 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Olaparib | 16 | 135 | 31 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Carboplatin + Gemcitabine | 23 | 133 | 65 |
| other | Lymphopenia | Blood and lymphatic system disorders | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 23 | 460 | 37 |
| other | Lymphopenia | Blood and lymphatic system disorders | Pembrolizumab + Olaparib | 11 | 135 | 20 |
| other | Lymphopenia | Blood and lymphatic system disorders | Pembrolizumab + Carboplatin + Gemcitabine | 5 | 133 | 18 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 218 | 460 | 485 |
1 to 10 of 489Source ClinicalTrials.gov
See all 489 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 124 | 460 |
| Total, all-cause mortality | Pembrolizumab + Olaparib | 50 | 135 |
| Total, all-cause mortality | Pembrolizumab + Carboplatin + Gemcitabine | 54 | 136 |
| Total, other adverse events | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 456 | 460 |
| Total, other adverse events | Pembrolizumab + Olaparib | 121 | 135 |
| Total, other adverse events | Pembrolizumab + Carboplatin + Gemcitabine | 128 | 133 |
| Total, serious adverse events | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 80 | 460 |
| Total, serious adverse events | Pembrolizumab + Olaparib | 35 | 135 |
| Total, serious adverse events | Pembrolizumab + Carboplatin + Gemcitabine | 32 | 133 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41405563 | RESULT |
Source PubMed
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 + Olaparib vs Pembrolizumab + Carboplatin + Gemcitabine: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Trial comparisons |
| Pembrolizumab + Olaparib vs Pembrolizumab + Carboplatin + Gemcitabine: Number of Participants Who Experienced At Least One Adverse Event (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/NCT04191135
GET https://conductscience.org/api/trials/v1/NCT04191135/registered?page=2