A Phase 2 interventional study of Pembrolizumab and Olaparib in Triple Negative Breast Neoplasms, sponsored by Merck Sharp & Dohme LLC. Terminated at 122 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:
As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.
1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.
This study's enrollment of 462 is above the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Induction Period:
Post-induction Period:
Exclusion Criteria:
Induction Period:
Post-induction Period:
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.
Biological: Pembrolizumab · Drug: Olaparib
This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Biological: Pembrolizumab · Drug: Carboplatin · Drug: Gemcitabine
intravenous (IV) infusion
Also known as: KEYTRUDA®, MK-3475
oral tablets
Also known as: LYNPARZA®, MK-7339, AZD2281, KU-0059436
IV infusion
Also known as: PARAPLATIN®
IV infusion
Also known as: GEMZAR®
Progression-Free Survival (PFS)
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.
Time frame: Up to approximately 29 months
Overall Survival (OS)
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.
Time frame: Up to approximately 29 months
Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10
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.
Time frame: Up to approximately 29 months
Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10
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.
Time frame: Up to approximately 29 months
PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
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.
Time frame: Up to approximately 29 months
OS in Participants With BRCAm Tumors
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.
Time frame: Up to approximately 29 months
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
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.
Time frame: Baseline and week 18
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
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.
Time frame: Baseline and week 18
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
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.
Time frame: Baseline and week 18
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
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.
Time frame: Baseline and week 18
Change From Baseline in Visual Analogue Scale (VAS) Score on the European Quality of Life 5-dimension, 5-level Questionnaire (EQ-5D-5L)
The EQ-5D-5L is a questionnaire developed to assess health-related outcomes. The VAS is a component of the EQ-5D-5L that asks participants to rate their overall health on a vertical visual analogue scale, with the scale's ends labelled 'The best health you can imagine' (equivalent to a score of 0) and 'The worst health you can imagine' (equivalent to a score of 100). The change from baseline in VAS 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.
Time frame: Baseline and week 18
Change From Baseline in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
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. The change from baseline in EORTC QLQ-C30 Items 29 and 30 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
Time frame: Baseline and up to 18 weeks
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors
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 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
Time frame: Baseline and week 18
Change From Baseline in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors
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. The 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
Time frame: Baseline and week 18
Change From Baseline in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors
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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
Time frame: Baseline and week 18
Change From Baseline in Visual Analogue Scale (VAS) Score on the EQ-5D-5L in Participants With BRCAm Tumors
The EQ-5D-5L is a questionnaire developed to assess health-related outcomes. The VAS is a component of the EQ-5D-5L that asks participants to rate their overall health on a vertical visual analogue scale, with the scale's ends labelled 'The best health you can imagine' (equivalent to a score of 0) and 'The worst health you can imagine' (equivalent to a score of 100). The change from baseline in VAS 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
Time frame: Baseline and week 18
Time to Deterioration (TTD) in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Baseline and up to approximately 29 months
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to approximately 29 months
TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in emotional functioning Items 21-24 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to approximately 29 months
TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four 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 to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in systemic therapy side effects Items 1-4, 6, 7 and 8 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to approximately 29 months
TTD in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Baseline and up to approximately 29 months
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to approximately 29 months
TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in emotional functioning Items 21-24 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to approximately 29 months
TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four 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 to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in systemic therapy side effects Items 1-4, 6, 7 and 8 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to approximately 29 months
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience at least 1 AE is presented.
Time frame: Up to approximately 29 months
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
Time frame: Up to approximately 29 months
| Milestone | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|---|
| Started | 462 | 0 | 0 |
| Treated | 460 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 462 | 0 | 0 |
| Withdrew: Not treated | 2 | 0 | 0 |
| Withdrew: Ongoing to blinded treatment period | 271 | 0 | 0 |
| Withdrew: Adverse event | 25 | 0 | 0 |
| Withdrew: Clinical progression | 8 | 0 | 0 |
| Withdrew: Excluded medication | 1 | 0 | 0 |
| Withdrew: Failure to meet continuation criteria | 2 | 0 | 0 |
| Withdrew: Failure to meet randomization criteria | 2 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 |
| Withdrew: Progressive disease | 135 | 0 | 0 |
| Withdrew: Protocol violation | 10 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 | 0 |
| Milestone | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|---|
| Started | 0 | 135 | 136 |
| Treated | 0 | 135 | 133 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 135 | 136 |
| Withdrew: Death | 0 | 50 | 54 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 |
| Withdrew: Ongoing in trial | 0 | 83 | 81 |
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.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Progression-Free Survival (PFS) | 5.5 (4.2 to 8.3) | 5.6 (4.3 to 6.9) |
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.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Overall Survival (OS) | 25.1 (18.3 to NA) | 23.4 (15.8 to NA) |
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.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10 | 5.7 (2.9 to 13.9) | 5.7 (3.8 to 7.6) |
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.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10 | NA (17.0 to NA) | NA (15.5 to NA) |
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.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors | 12.4 (8.3 to NA) | 8.4 (5.4 to NA) |
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.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| OS in Participants With BRCAm Tumors | NA (17.1 to NA) | 23.4 (17.3 to NA) |
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.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| 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 | -5.82 (-9.03 to -2.61) | -2.54 (-5.71 to 0.64) |
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.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| 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 | -2.86 (-6.29 to 0.57) | -2.69 (-6.09 to 0.70) |
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.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| 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 | -0.46 (-4.30 to 3.38) | -2.53 (-6.32 to 1.25) |
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.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| 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 | -0.91 (-3.27 to 1.44) | -1.84 (-4.17 to 0.48) |
The EQ-5D-5L is a questionnaire developed to assess health-related outcomes. The VAS is a component of the EQ-5D-5L that asks participants to rate their overall health on a vertical visual analogue scale, with the scale's ends labelled 'The best health you can imagine' (equivalent to a score of 0) and 'The worst health you can imagine' (equivalent to a score of 100). The change from baseline in VAS 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.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Change From Baseline in Visual Analogue Scale (VAS) Score on the European Quality of Life 5-dimension, 5-level Questionnaire (EQ-5D-5L) | -2.74 (-5.36 to -0.12) | -2.37 (-4.97 to 0.24) |
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. The change from baseline in EORTC QLQ-C30 Items 29 and 30 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Change From Baseline in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors | -4.85 (-12.43 to 2.73) | -3.51 (-11.17 to 4.15) |
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 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors | 4.12 (-0.68 to 8.92) | -0.70 (-5.62 to 4.21) |
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. The 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Change From Baseline in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors | -1.50 (-8.41 to 5.41) | -4.02 (-11.15 to 3.11) |
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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Change From Baseline in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors | -4.27 (-8.27 to -0.27) | -2.67 (-6.77 to 1.43) |
The EQ-5D-5L is a questionnaire developed to assess health-related outcomes. The VAS is a component of the EQ-5D-5L that asks participants to rate their overall health on a vertical visual analogue scale, with the scale's ends labelled 'The best health you can imagine' (equivalent to a score of 0) and 'The worst health you can imagine' (equivalent to a score of 100). The change from baseline in VAS 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), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.
| Score on a Scale | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Change From Baseline in Visual Analogue Scale (VAS) Score on the EQ-5D-5L in Participants With BRCAm Tumors | 1.73 (-3.08 to 6.54) | -3.83 (-8.77 to 1.11) |
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Time to Deterioration (TTD) in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score | 10.3 (4.2 to NA) | NA (13.2 to NA) |
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score | NA (NA to NA) | NA (NA to NA) |
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in emotional functioning Items 21-24 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score | NA (NA to NA) | NA (14.5 to NA) |
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four 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 to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in systemic therapy side effects Items 1-4, 6, 7 and 8 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score | NA (NA to NA) | NA (NA to NA) |
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| TTD in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors | 7.9 (3.7 to NA) | NA (3.5 to NA) |
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors | NA (10.4 to NA) | NA (NA to NA) |
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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in emotional functioning Items 21-24 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors | NA (7.9 to NA) | NA (15.4 to NA) |
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four 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 to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in systemic therapy side effects Items 1-4, 6, 7 and 8 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors | NA (NA to NA) | NA (NA to NA) |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience at least 1 AE is presented.
| Participants | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Number of Participants Who Experienced At Least One Adverse Event (AE) | 126 | 130 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
| Participants | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | 15 | 28 |
Collected over Up to approximately 29 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | 124/460 (27%) | 80/460 (17.4%) | 456/460 (99.1%) |
| Pembrolizumab + Olaparib | 50/135 (37%) | 35/135 (25.9%) | 121/135 (89.6%) |
| Pembrolizumab + Carboplatin + Gemcitabine | 54/136 (39.7%) | 32/133 (24.1%) | 128/133 (96.2%) |
| Event | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|---|
| PneumoniaInfections and infestations | 5/460 | 2/135 | 3/133 |
| PyrexiaGeneral disorders | 1/460 | 3/135 | 1/133 |
| Febrile neutropeniaBlood and lymphatic system disorders | 8/460 | 1/135 | 0/133 |
| AnaemiaBlood and lymphatic system disorders | 6/460 | 2/135 | 2/133 |
| PancytopeniaBlood and lymphatic system disorders | 3/460 | 1/135 | 2/133 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/460 | 0/135 | 2/133 |
| Upper respiratory tract infectionInfections and infestations | 0/460 | 0/135 | 2/133 |
| Platelet count decreasedInvestigations | 1/460 | 1/135 | 2/133 |
| Haemophagocytic lymphohistiocytosisImmune system disorders | 0/460 | 2/135 | 0/133 |
| SepsisInfections and infestations | 0/460 | 2/135 | 0/133 |
| Event | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 274/460 | 54/135 | 69/133 |
| NeutropeniaBlood and lymphatic system disorders | 218/460 | 28/135 | 55/133 |
| NauseaGastrointestinal disorders | 207/460 | 51/135 | 36/133 |
| Alanine aminotransferase increasedInvestigations | 162/460 | 8/135 | 32/133 |
| Neutrophil count decreasedInvestigations | 141/460 | 18/135 | 42/133 |
| ThrombocytopeniaBlood and lymphatic system disorders | 133/460 | 22/135 | 41/133 |
| ConstipationGastrointestinal disorders | 141/460 | 14/135 | 13/133 |
| Aspartate aminotransferase increasedInvestigations | 136/460 | 10/135 | 29/133 |
| Platelet count decreasedInvestigations | 95/460 | 16/135 | 36/133 |
| FatigueGeneral disorders | 124/460 | 22/135 | 23/133 |
| Age, Continuous(Years) | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine | Total |
|---|---|---|---|---|
| Mean | 53.8 ± 12.7 | 53.9 ± 12.0 | 52.9 ± 12.5 | 53.6 ± 12.4 |
| Sex: Female, Male(Participants) | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine | Total |
|---|---|---|---|---|
| Female | 188 | 135 | 136 | 459 |
| Male | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine | Total |
|---|---|---|---|---|
| Hispanic or Latino | 26 | 33 | 19 | 78 |
| Not Hispanic or Latino | 137 | 79 | 102 | 318 |
| Unknown or Not Reported | 26 | 23 | 15 | 64 |
| Race (NIH/OMB)(Participants) | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Pembrolizumab + Olaparib | Pembrolizumab + Carboplatin + Gemcitabine | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 2 | 5 |
| Asian | 39 | 29 | 30 | 98 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 6 | 5 | 2 | 13 |
| White | 112 | 70 | 84 | 266 |
| More than one race | 7 | 14 | 7 | 28 |
| Unknown or Not Reported | 21 | 17 | 11 | 49 |
Showing the first 100 of 122 sites across 15 countries.
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