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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7339-009 | Other Identifier | MSD | |
| KEYLYNK-009 | Other Identifier | MSD | |
| 195082 | Registry Identifier | JAPIC-CTI | |
| 2022-500418-24-00 | Registry Identifier | EU CT | |
| U1111-1275-8575 | Registry Identifier | UTN | |
| 2019-001892-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + Olaparib | Experimental | 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. |
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| Pembrolizumab + Carboplatin + Gemcitabine | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to approximately 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Induction Period:
Post-induction Period:
Exclusion Criteria:
Induction Period:
Post-induction Period:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Care ( Site 0142) | Monterey | California | 93940 | United States | ||
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41405563 | Result | Rugo HS, Cescon DW, Robson ME, Im SA, Dalenc F, Yanez Ruiz E, Reyes-Cosmelli F, Walshe JM, Im YH, Kulyk S, Dudnichenko O, Llinas-Quintero N, Saji S, Miyoshi Y, Bardia A, Harbeck N, Haiderali A, Fan L, Mejia JA, Karantza V, Llombart-Cussac A. KEYLYNK-009: Pembrolizumab plus Olaparib in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer after Clinical Benefit from First-Line Pembrolizumab plus Chemotherapy. Clin Cancer Res. 2026 Mar 2;32(5):883-893. doi: 10.1158/1078-0432.CCR-25-1818. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Participants receive both carboplatin Area Under The Curve (AUC) 2 with gemcitabine 1000 mg/m^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. Participants may then randomize to one of the blinded treatment arms. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Treatment |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2023 |
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| Olaparib | Drug | oral tablets |
|
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| Carboplatin | Drug | IV infusion |
|
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| Gemcitabine | Drug | IV infusion |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to approximately 29 months |
| San Francisco |
| California |
| 94158 |
| United States |
| John Wayne Cancer Institute ( Site 0111) | Santa Monica | California | 90404 | United States |
| St. Joseph Heritage Healthcare ( Site 0104) | Santa Rosa | California | 95403 | United States |
| University of Miami Sylvester CC ( Site 0146) | Miami | Florida | 33136 | United States |
| Georgia Cancer Center at Augusta University ( Site 0129) | Augusta | Georgia | 30912 | United States |
| University of Chicago ( Site 0159) | Chicago | Illinois | 60637 | United States |
| Massachusetts General Hospital ( Site 0155) | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System ( Site 0103) | Detroit | Michigan | 48202 | United States |
| Virginia Piper Cancer Institute ( Site 0157) | Minneapolis | Minnesota | 55407 | United States |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161) | Middletown | New Jersey | 07748 | United States |
| MSKCC-Bergen ( Site 0162) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160) | Commack | New York | 11725 | United States |
| Memorial Sloan-Kettering Cancer Center ( Site 0156) | New York | New York | 10065 | United States |
| Mercy Clinic Oncology and Hematology ( Site 0110) | Oklahoma City | Oklahoma | 73120 | United States |
| The Center For Cancer And Blood Disorders ( Site 0151) | Fort Worth | Texas | 76104 | United States |
| Texas Oncology-New Braunfels ( Site 0168) | New Braunfels | Texas | 78130 | United States |
| Texas Oncology-San Antonio Northeast ( Site 0165) | San Antonio | Texas | 78217 | United States |
| Texas Oncology-San Antonio Medical Center ( Site 0158) | San Antonio | Texas | 78240 | United States |
| Texas Oncology - San Antonio Stone Oak ( Site 0166) | San Antonio | Texas | 78258 | United States |
| Renovatio Clinical ( Site 0117) | The Woodlands | Texas | 77380 | United States |
| Virginia Oncology Associates ( Site 0163) | Newport News | Virginia | 23606 | United States |
| Virginia Oncology Associates ( Site 0153) | Norfolk | Virginia | 23502 | United States |
| Virginia Oncology Associates ( Site 0164) | Virginia Beach | Virginia | 23456 | United States |
| YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128) | Yakima | Washington | 98902 | United States |
| Princess Margaret Cancer Centre ( Site 0005) | Toronto | Ontario | M5G 2M9 | Canada |
| CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011) | Laval | Quebec | H7M 3L9 | Canada |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003) | Montreal | Quebec | H2X 3E4 | Canada |
| Jewish General Hospital ( Site 0010) | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre ( Site 0002) | Montreal | Quebec | H4A 3J1 | Canada |
| Centro Investigación del Cáncer James Lind ( Site 0510) | Temuco | Araucania | 4780000 | Chile |
| IC La Serena Research ( Site 0511) | La Serena | Coquimbo Region | 1720430 | Chile |
| Fundacion Arturo Lopez Perez ( Site 0500) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Pontificia Universidad Catolica de Chile ( Site 0501) | Santiago | Region M. de Santiago | 8330032 | Chile |
| Oncocentro ( Site 0502) | Viña del Mar | Valparaiso | 2520598 | Chile |
| Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601) | Medellín | Antioquia | 050030 | Colombia |
| Clinica de la Costa Ltda. ( Site 0600) | Barranquilla | Atlántico | 080020 | Colombia |
| Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609) | Barranquilla | Atlántico | 080020 | Colombia |
| Oncomedica S.A. ( Site 0606) | Montería | Departamento de Córdoba | 230002 | Colombia |
| Fundacion Valle del Lili ( Site 0602) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Hemato Oncologos S.A. ( Site 0603) | Cali | Valle del Cauca Department | 760042 | Colombia |
| Centre Francois Baclesse ( Site 1012) | Caen | Calvados | 14076 | France |
| CHU-Jean Minjoz ( Site 1013) | Besançon | Doubs | 25030 | France |
| Institut Claudius Regaud IUCT Oncopole ( Site 1001) | Toulouse | Haute-Garonne | 31059 | France |
| Centre de Cancerologie du Grand Montpellier ( Site 1009) | Montpellier | Languedoc-Roussillon | 34070 | France |
| CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007) | Metz | Moselle | 57085 | France |
| Centre Jean Perrin ( Site 1003) | Clermont-Ferrand | Puy-de-Dome | 63001 | France |
| Centre Leon Berard ( Site 1018) | Lyon | Rhone | 69373 | France |
| Centre Henri Becquerel ( Site 1020) | Rouen | Seine-Maritime | 76038 | France |
| CHU Amiens Hopital Sud ( Site 1023) | Amiens | Somme | 80000 | France |
| Institut Gustave Roussy ( Site 1010) | Villejuif | Val-de-Marne | 94805 | France |
| Institut Sainte Catherine ( Site 1026) | Avignon | Vaucluse | 84918 | France |
| Hôpital Saint-Louis ( Site 1025) | Paris | 75010 | France |
| Universitaetsklinikum Mannheim GmbH ( Site 1213) | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Universitaetsklinikum Erlangen ( Site 1201) | Erlangen | Bavaria | 91054 | Germany |
| Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200) | Munich | Bavaria | 80337 | Germany |
| Hochwaldkrankenhaus Bad Nauheim ( Site 1211) | Bad Nauheim | Hesse | 61231 | Germany |
| Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206) | Offenbach | Hesse | 63069 | Germany |
| Gynaekologisch-onkologische Praxis Hannover ( Site 1207) | Hanover | Lower Saxony | 30177 | Germany |
| Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205) | Bonn | North Rhine-Westphalia | 53111 | Germany |
| Universitaetsklinikum AoeR Duesseldorf ( Site 1210) | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Kliniken Essen-Mitte ( Site 1215) | Essen | North Rhine-Westphalia | 45136 | Germany |
| Frauenklinik St. Louise ( Site 1216) | Paderborn | North Rhine-Westphalia | 33098 | Germany |
| Universitaetsklinikum Carl Gustav Carus ( Site 1203) | Dresden | Saxony | 01307 | Germany |
| Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607) | Pécs | Baranya | 7624 | Hungary |
| Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608) | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601) | Szolnok | Jász-Nagykun-Szolnok | 5000 | Hungary |
| Zala Megyei Szent Rafael Korhaz ( Site 1605) | Zalaegerszeg | Zala County | 8900 | Hungary |
| Orszagos Onkologiai Intezet ( Site 1602) | Budapest | 1122 | Hungary |
| Debreceni Egyetem Klinikai Kozpont ( Site 1600) | Debrecen | 4032 | Hungary |
| Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604) | Kaposvár | 7400 | Hungary |
| Cork University Hospital ( Site 0902) | Cork | T12 DC4A | Ireland |
| St Vincents University Hospital ( Site 0900) | Dublin | D04 YN63 | Ireland |
| Aichi Cancer Center Hospital ( Site 2202) | Nagoya | Aichi-ken | 464-8681 | Japan |
| Hyogo College of Medicine Hospital ( Site 2203) | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Fukushima Medical University Hospital ( Site 2201) | Fukushima | 960-1295 | Japan |
| Hiroshima City Hiroshima Citizens Hospital ( Site 2204) | Hiroshima | 730-8518 | Japan |
| National Hospital Organization - Osaka National Hospital - Institute For Clinical Research (Site 2200) | Osaka | 540-0006 | Japan |
| Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909) | Pleszew | Greater Poland Voivodeship | 65-300 | Poland |
| Pratia MCM Krakow ( Site 1919) | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Regionalny Szpital Specjalistyczny Latawiec ( Site 1917) | Swidnica | Lower Silesian Voivodeship | 58-100 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Site 1908) | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913) | Gdynia | Pomeranian Voivodeship | 81-519 | Poland |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912) | Gliwice | Silesian Voivodeship | 44-102 | Poland |
| National Cancer Center ( Site 2406) | Goyang-si | Kyonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital ( Site 2409) | Seongnam-si | Kyonggi-do | 13605 | South Korea |
| Ajou University Hospital ( Site 2407) | Suwon | Kyonggi-do | 16499 | South Korea |
| Kyungpook National University Chilgok Hospital ( Site 2402) | Daegu | Taegu-Kwangyokshi | 41404 | South Korea |
| Gachon University Gil Medical Center ( Site 2408) | Incheon | 21565 | South Korea |
| Seoul National University Hospital ( Site 2403) | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 2401) | Seoul | 03722 | South Korea |
| Asan Medical Center ( Site 2404) | Seoul | 05505 | South Korea |
| Samsung Medical Center ( Site 2405) | Seoul | 06351 | South Korea |
| Hospital Universitario Reina Sofia ( Site 0705) | Córdoba | Andalusia | 14004 | Spain |
| Hospital General Arnau de Vilanova de Valencia ( Site 0706) | Valencia | Valenciana, Comunitat | 46015 | Spain |
| Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707) | Barcelona | 08023 | Spain |
| Hospital Universitari Vall d Hebron ( Site 0701) | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial de Barcelona ( Site 0702) | Barcelona | 08036 | Spain |
| Clinica Universitaria Navarra - Madrid ( Site 0700) | Madrid | 28027 | Spain |
| Kaohsiung Chang Gung Memorial Hospital ( Site 2304) | Kaohsiung City | 83301 | Taiwan |
| National Cheng Kung University Hospital ( Site 2303) | Tainan | 704 | Taiwan |
| MacKay Memorial Hospital ( Site 2301) | Taipei | 10449 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300) | Taipei | 112 | Taiwan |
| China Medical University Hospital ( Site 2302) | Taipei | 40447 | Taiwan |
| Chernihiv Medical Center of Modern Oncology ( Site 1520) | Chernihiv | Chernihiv Oblast | 14029 | Ukraine |
| Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502) | Dnipro | Dnipropetrovsk Oblast | 49102 | Ukraine |
| CI Krivorizhskiy oncology dispensery ( Site 1504) | Kryviy Rih | Dnipropetrovsk Oblast | 50048 | Ukraine |
| MI Precarpathian Clinical Oncology Center ( Site 1506) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508) | Kharkiv | Kharkiv Oblast | 61024 | Ukraine |
| Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512) | Kharkiv | Kharkiv Oblast | 61070 | Ukraine |
| SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518) | Kharkiv | Kharkiv Oblast | 61103 | Ukraine |
| Medical Centre Consilium Medical ( Site 1514) | Kyiv | Kyivska Oblast | 04050 | Ukraine |
| Medical center of the Limited Liability Company Yulis ( Site 1517) | Zaporizhzhia | Zaporizhzhia Oblast | 69035 | Ukraine |
| Medical Centre LLC Oncolife ( Site 1510) | Zaporizhzhya | Zaporizhzhia Oblast | 69104 | Ukraine |
| Zhytomyr Regional Oncology Center ( Site 1515) | Zhytomyr | Zhytomyr Oblast | 10002 | Ukraine |
| Medical Center Verum ( Site 1501) | Kyiv | 03039 | Ukraine |
| Raigmore Hospital ( Site 0915) | Inverness | Highland | IV2 3UJ | United Kingdom |
| Blackpool Victoria Hospital ( Site 0921) | Blackpool | Lancashire | FY3 8NR | United Kingdom |
| Barts Health NHS Trust ( Site 0912) | London | London, City of | EC1M 6BQ | United Kingdom |
| North West Cancer Centre ( Site 0922) | Londonderry | London, City of | BT47 6SB | United Kingdom |
| Musgrove Park Hospital ( Site 0918) | Taunton | Somerset | TA1 5DA | United Kingdom |
| The Christie NHS Foundation Trust ( Site 0914) | Manchester | M20 4BX | United Kingdom |
| Plain Language Summary | View source |
| FG001 | Pembrolizumab + Olaparib | 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. |
| FG002 | Pembrolizumab + Carboplatin + Gemcitabine | 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. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Randomized Treatment |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Participants receive both carboplatin Area Under The Curve (AUC) 2 with gemcitabine 1000 mg/m^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. These participants did not randomize to a post-induction arm. |
| BG001 | Pembrolizumab + Olaparib | 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. |
| BG002 | Pembrolizumab + Carboplatin + Gemcitabine | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The analysis population included all randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Primary | 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. | The analysis population included all randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | 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. | The analysis populations included all randomized participants with a CPS ≥10 | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | 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. | The analysis population included all randomized participants with a CPS ≥10 | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| 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 | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| 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 | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| 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 | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| 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 | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| Secondary | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to 18 weeks |
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| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and week 18 |
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| Secondary | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 29 months |
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| Secondary | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | 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. | The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 29 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population included all randomized participants who received ≥1 dose of study drug and who had at least 1 laboratory or vital sign measurement. | Posted | Count of Participants | Participants | Up to approximately 29 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population included all randomized participants who received ≥1 dose of study drug and who had at least 1 laboratory or vital sign measurement. | Posted | Count of Participants | Participants | Up to approximately 29 months |
|
Up to approximately 29 months
Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment | Participants receive both carboplatin Area Under The Curve (AUC) 2 with gemcitabine 1000 mg/m^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. Participants may then randomize to one of the blinded treatment arms. | 124 | 460 | 80 | 460 | 456 | 460 |
| EG001 | Pembrolizumab + Olaparib | 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. | 50 | 135 | 35 | 135 | 121 | 135 |
| EG002 | Pembrolizumab + Carboplatin + Gemcitabine | 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. | 54 | 136 | 32 | 133 | 128 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Appendicitis noninfective | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Central nervous system necrosis | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Dec 8, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C531550 | olaparib |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Withdrawal by Subject |
|
| Ongoing in Trial |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Counts |
|---|
| Participants |
|
|
|
| OG001 | Pembrolizumab + Carboplatin + Gemcitabine | 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. |
|
|
|
| Pembrolizumab + Carboplatin + Gemcitabine |
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. |
|
|
|
| Pembrolizumab + Carboplatin + Gemcitabine |
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. |
|
|
|
| OG001 | Pembrolizumab + Carboplatin + Gemcitabine | 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. |
|
|
|
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.
|
|
|
| OG001 | Pembrolizumab + Carboplatin + Gemcitabine | 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. |
|
|
|
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. |
|
|
|
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. |
|
|
|
| OG001 | Pembrolizumab + Carboplatin + Gemcitabine | 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. |
|
|
|
|
|
|
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. |
|
|
|
|
|
|
|
|
|
| Pembrolizumab + Carboplatin + Gemcitabine |
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. |
|
|
|
| Pembrolizumab + Carboplatin + Gemcitabine |
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. |
|
|
|
|
|
|
|
|
|
| OG001 |
| Pembrolizumab + Carboplatin + Gemcitabine |
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. |
|
|
|
|
|
|
|