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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4830-002 | Other Identifier | MSD | |
| 2023-505005-16-00 | Registry Identifier | EU CT | |
| U1111-1290-6634 | Registry Identifier | UTN | |
| 2021-005458-27 | EudraCT Number |
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The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + Standard of Care (SOC) + MK-4830 | Experimental | Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), carboplatin Area Under the Curve (AUC) 5 to 6, and MK-4830 800 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), carboplatin AUC 5 to 6, and MK-4830 800 mg (with avastin [or biosimilar] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
|
| Pembrolizumab + SOC | Active Comparator | Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), and carboplatin AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), and carboplatin AUC 5 to 6 (with avastin [or biosimilar] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | 200 mg by IV infusion on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) | Blood samples were collected to determine levels of ctDNA. The fold change in the mean mutant/tumor molecules per mL (MTM/mL) at Cycle 3 from baseline is presented. | Baseline and Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA | Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. Per protocol, change from baseline in ctDNA in participants with surgery and pCR was reported. | Baseline and Week 12 |
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
Females with advanced high-grade serous ovarian cancer (HGSOC), fallopian tube cancer, or primary peritoneal cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108) | Aurora | Colorado | 80045 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab + Standard of Care (SOC) + MK-4830 | Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 10, 2024 |
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|
| Paclitaxel | Drug | 175 mg/m^2 by IV infusion on Day 1 of each 21-day cycle |
|
|
| Carboplatin | Drug | AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle |
|
|
| Avastin | Biological | According to local practice and at the choice of the investigator. |
|
|
| MK-4830 | Biological | 800 mg by IV infusion on Day 1 of each 21-day cycle |
|
| Docetaxel | Drug | 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle |
|
| Association of Change From Baseline in ctDNA With pCR | Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. pCR rate was defined as percentage of participants with pCR. Per protocol, the association of change from baseline in ctDNA with pCR in participants with surgery and pCR was reported. | Baseline and Week 12 |
| Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA | Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. Per protocol, change from baseline in ctDNA in participants with surgery and CRS was reported. | Baseline and Week 12 |
| Association of Change From Baseline in ctDNA With CRS3 | Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, the association of change from baseline in ctDNA with CRS3 in participants with surgery and CRS was reported. | Baseline and Week 12 |
| pCR Rate | pCR rate was defined as the percentage of participants with all surgical specimens collected during the interval debulking surgery that were microscopically negative for residual tumor. The pCR rate as assessed by local pathologist was reported. | Up to approximately 12 weeks |
| CRS3 Rate | CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, CRS3 rate as assessed by local pathologist was reported. | Up to approximately 12 weeks |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was 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 could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported. | Up to approximately 26 months |
| Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was 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 could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study intervention due to an AE was reported. | Up to approximately 28 weeks |
| Mayo Clinic in Florida ( Site 0101) |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Miami Cancer Institute at Baptist Health, Inc. ( Site 0110) | Miami | Florida | 33176 | United States |
| Northwestern Memorial Hospital ( Site 0104) | Chicago | Illinois | 60611 | United States |
| Washington University ( Site 0113) | St Louis | Missouri | 63110 | United States |
| Rutgers Cancer Institute of New Jersey ( Site 0114) | New Brunswick | New Jersey | 08901 | United States |
| Roswell Park Cancer Institute ( Site 0106) | Buffalo | New York | 14263 | United States |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116) | Mineola | New York | 11501 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107) | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center ( Site 0102) | New York | New York | 10065 | United States |
| Sanford Cancer Center-Gynecologic Oncology ( Site 0115) | Sioux Falls | South Dakota | 57104 | United States |
| Fred Hutchinson Cancer Center ( Site 0100) | Seattle | Washington | 98109 | United States |
| Antwerp University Hospital-Oncology ( Site 1301) | Edegem | Antwerpen | 2650 | Belgium |
| AZ Maria Middelares-IKG ( Site 1302) | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Leuven ( Site 1300) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Centre Hospitalier de l'Université de Montréal ( Site 0300) | Montreal | Quebec | H2X 3E4 | Canada |
| McGill University Health Centre ( Site 0301) | Montreal | Quebec | H4A 3J1 | Canada |
| James Lind Centro de Investigación del Cáncer ( Site 0903) | Temuco | Araucania | 4800827 | Chile |
| FALP ( Site 0905) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900) | Santiago | Region M. de Santiago | 8330032 | Chile |
| ONCOCENTRO APYS-ACEREY ( Site 0904) | Viña del Mar | Valparaiso | 2520598 | Chile |
| Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602) | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center ( Site 0601) | Jerusalem | 9103102 | Israel |
| Sheba Medical Center-ONCOLOGY ( Site 0600) | Ramat Gan | 5265601 | Israel |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 0 | Naples | Campania | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502) | Rome | Lazio | oo168 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050 | Milan | Lombardy | 20133 | Italy |
| Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501) | Milan | 20141 | Italy |
| Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709) | Poznan | Greater Poland Voivodeship | 61-848 | Poland |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701) | Siedlce | Masovian Voivodeship | 08-110 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708) | Kielce | Świętokrzyskie Voivodeship | 25-734 | Poland |
| National Cancer Centre Singapore ( Site 1501) | Singapore | Central Singapore | 168583 | Singapore |
| National University Hospital ( Site 1502) | Singapore | South West | 119074 | Singapore |
| Seoul National University Hospital ( Site 0801) | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800) | Seoul | 03722 | South Korea |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103) | Hospitalet | Barcelona | 08907 | Spain |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104) | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101) | Barcelona | 08035 | Spain |
| Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203) | Changhua County | Changhua | 50006 | Taiwan |
| Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202) | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital ( Site 1201) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital-Internal Medicine ( Site 1200) | Taipei | 10002 | Taiwan |
| Mackay Memorial Hospital ( Site 1204) | Taipei | 10449 | Taiwan |
| FG001 | Pembrolizumab + SOC | Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab + Standard of Care (SOC) + MK-4830 | Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
| BG001 | Pembrolizumab + SOC | Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Detectable Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA) | Participants' blood samples were assessed at baseline for ctDNA mean mutant/tumor molecules per mL (MTM/mL). | Only participants with detectable ctDNA at baseline were included. | Mean | Standard Deviation | MTM/mL |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA | Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. Per protocol, change from baseline in ctDNA in participants with surgery and pCR was reported. | All randomized participants who received at least one dose of study intervention, had surgery, and had pCR and ctDNA data available for assessment. | Posted | Mean | Standard Deviation | Fold Change | Baseline and Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Association of Change From Baseline in ctDNA With pCR | Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. pCR rate was defined as percentage of participants with pCR. Per protocol, the association of change from baseline in ctDNA with pCR in participants with surgery and pCR was reported. | All randomized participants who received at least one dose of study intervention, had surgery, and had pCR and ctDNA data available for assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA | Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. Per protocol, change from baseline in ctDNA in participants with surgery and CRS was reported. | All randomized participants who received at least one dose of study intervention, had surgery, and had CRS and ctDNA data available for assessment. | Posted | Mean | Standard Deviation | Fold Change | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Association of Change From Baseline in ctDNA With CRS3 | Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, the association of change from baseline in ctDNA with CRS3 in participants with surgery and CRS was reported. | All randomized participants who received at least one dose of study intervention, had surgery, and had CRS and ctDNA data available for assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Week 12 |
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| Secondary | pCR Rate | pCR rate was defined as the percentage of participants with all surgical specimens collected during the interval debulking surgery that were microscopically negative for residual tumor. The pCR rate as assessed by local pathologist was reported. | All randomized participants who received at least one dose of study intervention, received surgery, and had pCR data available for assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 12 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | CRS3 Rate | CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, CRS3 rate as assessed by local pathologist was reported. | All randomized participants who received at least one dose of study intervention, received surgery, and had CRS data available for assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 12 weeks |
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| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was 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 could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported. | All randomized participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 26 months |
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| Secondary | Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was 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 could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study intervention due to an AE was reported. | All randomized participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 28 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) | Blood samples were collected to determine levels of ctDNA. The fold change in the mean mutant/tumor molecules per mL (MTM/mL) at Cycle 3 from baseline is presented. | All randomized participants who received at least one dose of study intervention, had detectable ctDNA at baseline, and had assessed ctDNA at Cycle 3. | Posted | Mean | Standard Deviation | Fold change | Baseline and Week 7 |
|
Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab + Standard of Care (SOC) + MK-4830 | Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. | 6 | 80 | 28 | 79 | 75 | 79 |
| EG001 | Pembrolizumab + SOC | Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. | 5 | 80 | 33 | 80 | 79 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Superior mesenteric artery syndrome | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Serositis | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated hepatic disorder | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Papillary serous endometrial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | 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@msd.com |
| Nov 27, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
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Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
|
|
| Pembrolizumab + SOC |
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. |
|
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|
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin [or biosimilar] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
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