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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-A18 | Other Identifier | MSD | |
| KEYNOTE-A18 | Other Identifier | MSD | |
| ENGOT-cx11 | Other Identifier | European Network for Gynaecological Oncological Trial groups | |
| 205189 | Registry Identifier | JAPAC-CTI | |
| GOG-3047 | Other Identifier | Gynecologic Oncology Group Foundation | |
| 2022-501972-25-00 | Registry Identifier | EU CT | |
| U1111-1282-6395 | Registry Identifier | UTN | |
| 2019-003152-37 | EudraCT Number |
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| Name | Class |
|---|---|
| GOG Foundation | NETWORK |
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
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The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.
The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.
Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemoradiotherapy + pembrolizumab | Experimental | Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
|
| chemoradiotherapy + placebo for pembrolizumab | Experimental | Participants receive placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. | Up to approximately 55 months |
| Overall Survival (OS) | OS is the time from randomization to death due to any cause. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate OS. | Up to approximately 55 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute - Biltmore ( Site 8009) | Phoenix | Arizona | 85016 | United States | ||
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38521086 | Result | Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Sukhin V, Cloven N, Pereira de Santana Gomes AJ, Contreras Mejia F, Reiss A, Ayhan A, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Lazzari R, Chang CL, Lampe R, Zhu H, Oaknin A, Christiaens M, Polterauer S, Usami T, Li K, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial. Lancet. 2024 Apr 6;403(10434):1341-1350. doi: 10.1016/S0140-6736(24)00317-9. Epub 2024 Mar 20. | |
| 39288779 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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The following participants were enrolled: had high-risk IB2-IIB (node-positive) or Stage III-IVA locally advanced cervical cancer (LACC); had histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix; had not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and was immunotherapy-naïve; had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemoradiotherapy + Pembrolizumab | Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
| 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 | Nov 8, 2022 |
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| Placebo for pembrolizumab | Drug | IV infusion |
|
| Cisplatin | Drug | IV infusion |
|
|
| External Beam Radiotherapy (EBRT) | Radiation | Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed |
|
| Brachytherapy | Radiation | Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed |
|
| Up to approximately 55 months |
| PFS Per RECIST 1.1 at Month 24 as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by the investigator is presented. | 24 months |
| PFS Per RECIST 1.1 at Month 24 as Assessed by BICR | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by BICR is presented. | 24 months |
| Overall Survival (OS) at Month 36 | OS is the time from randomization to death due to any cause. The analysis was performed via Kaplan-Meier approach to estimate the OS rate at Month 36. The percentage of participants with OS at Month 36 is presented. | 36 months |
| Complete Response (CR) Rate Per RECIST 1.1 at Week 12 as Assessed by the Investigator | For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. The percentage of participants with CR per RECIST 1.1 as assessed by the investigator at Week 12 is presented. | 12 weeks |
| CR Rate Per RECIST 1.1 at Week 12 as Assessed by BICR | For participants who demonstrated a confirmed CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. The percentage of participants with CR per RECIST 1.1 as assessed by BICR at Week 12 is presented. | 12 weeks |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by the Investigator | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. | Up to approximately 55 months |
| ORR Per RECIST 1.1 as Assessed by BICR | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. | Up to approximately 55 months |
| PFS Per RECIST 1.1 in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PD-L1 positive participants have a combined positivity score (CPS) equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. | Up to approximately 55 months |
| PFS Per RECIST 1.1 in PD-L1 Positive Participants as Assessed by BICR | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PD-L1 positive participants have a CPS equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. | Up to approximately 55 months |
| OS in PD-L1 Positive Participants | OS is the time from randomization to death due to any cause. PD-L1 positive participants have a CPS equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate OS. | Up to approximately 55 months |
| PFS After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment | PFS is defined as the time from randomization to the first documented progressive disease (PD) on next-line treatment or death due to any cause, whichever occurs first, as assessed by the investigator. PFS 2 is measured after next-line treatment following discontinuation of study treatment administration. | Up to approximately 55 months |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score | The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented. | Baseline and week 36 |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented. | Baseline and week 36 |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score | The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. Total scores are linearly transformed and range from 0 (no symptoms) to 100 (most severe symptoms). The change from baseline in EORTC QLQ-CX24 score is presented, with negative scores representing an improvement from baseline and vice versa. | Baseline and Week 36 |
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to 55 months |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to 32 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| Hoag Memorial Hospital Presbyterian ( Site 0038) | Newport Beach | California | 92663 | United States |
| UC Davis Comprehensive Cancer Center ( Site 0017) | Sacramento | California | 95817 | United States |
| University of Colorado Health Sciences Center and Hospital ( Site 0028) | Denver | Colorado | 80262 | United States |
| Smilow Cancer Center at Yale-New Haven ( Site 0023) | New Haven | Connecticut | 06510 | United States |
| AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009) | Orlando | Florida | 32804 | United States |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0026) | Fort Wayne | Indiana | 46845 | United States |
| University of Kentucky Markey Cancer Center ( Site 0015) | Lexington | Kentucky | 40536 | United States |
| Our Lady of the Lake Regional Medical Center. ( Site 0031) | Baton Rouge | Louisiana | 70817 | United States |
| Women's Cancer Care ( Site 0039) | Covington | Louisiana | 70433 | United States |
| Karmanos Cancer Institute ( Site 0018) | Detroit | Michigan | 48201 | United States |
| Minnesota Oncology Hematology, PA ( Site 8007) | Minneapolis | Minnesota | 55404 | United States |
| University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019) | Albuquerque | New Mexico | 87106 | United States |
| University of North Carolina at Chapel Hill ( Site 0025) | Chapel Hill | North Carolina | 27514 | United States |
| Sanford Bismarck Medical Center ( Site 0046) | Bismarck | North Dakota | 58501 | United States |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C | Columbus | Ohio | 43210 | United States |
| Willamette Valley Cancer Institute and Research Center ( Site 8000) | Eugene | Oregon | 97401 | United States |
| Legacy Good Samaritan Medical Center ( Site 0013) | Portland | Oregon | 97210 | United States |
| Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030) | Pittsburgh | Pennsylvania | 15244 | United States |
| Hollings Cancer Center ( Site 0007) | Charleston | South Carolina | 29425 | United States |
| Sanford Gynecology Oncology ( Site 0003) | Sioux Falls | South Dakota | 57104 | United States |
| Texas Oncology-Austin Central ( Site 8006) | Austin | Texas | 78731 | United States |
| Texas Oncology-Fort Worth Cancer Center ( Site 8001) | Fort Worth | Texas | 76104 | United States |
| Texas Oncology-San Antonio Medical Center ( Site 8002) | San Antonio | Texas | 78240 | United States |
| Texas Oncology-The Woodlands ( Site 8003) | The Woodlands | Texas | 77380 | United States |
| UVA Health System ( Site 0005) | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University ( Site 0024) | Richmond | Virginia | 23219 | United States |
| Westmead Hospital ( Site 0973) | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women s Hospital ( Site 0972) | Herston | Queensland | 4029 | Australia |
| Monash Health-Monash Medical Centre ( Site 0970) | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre ( Site 0971) | Melbourne | Victoria | 3000 | Australia |
| St John of God Subiaco Hospital ( Site 0969) | Subiaco | Western Australia | 6008 | Australia |
| Medizinische Universität Wien ( Site 0567) | Vienna | State of Vienna | 1090 | Austria |
| Medizinische Universitat Graz ( Site 0569) | Graz | Styria | 8036 | Austria |
| Medizinische Universitat Innsbruck ( Site 0566) | Innsbruck | Tyrol | 6020 | Austria |
| UZA University Hospital Antwerp ( Site 0351) | Edegem | Antwerpen | 2650 | Belgium |
| GZA Sint Augustinus ( Site 0356) | Wilrijk | Antwerpen | 2610 | Belgium |
| C.I.U. Hopital Ambroise Pare ( Site 0353) | Mons | Hainaut | 7000 | Belgium |
| OLV Ziekenhuis ( Site 0352) | Aalst | Oost-Vlaanderen | 9300 | Belgium |
| AZ St Lucas ( Site 0349) | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Leuven ( Site 0354) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Hospital das Clinicas da UFMG ( Site 0172) | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Liga Norte Riograndense Contra o Cancer ( Site 0170) | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| Hospital de Clínicas de Ribeirão Preto ( Site 0171) | Ribeirão Preto | São Paulo | 14048900 | Brazil |
| Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166) | São Paulo | São Paulo | 04014-002 | Brazil |
| Instituto Nacional Do Cancer II ( Site 0173) | Rio de Janeiro | 20220-410 | Brazil |
| Princess Margaret Cancer Centre ( Site 0102) | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101) | Montreal | Quebec | H2X 0A9 | Canada |
| McGill University Health Centre ( Site 0105) | Montreal | Quebec | H4A 3J1 | Canada |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 | Québec | Quebec | G1J 1Z4 | Canada |
| Centro Investigación del Cáncer James Lind ( Site 0194) | Temuco | Araucania | 4800827 | Chile |
| Sociedad Oncovida S.A. ( Site 0196) | Santiago | Region M. de Santiago | 7510032 | Chile |
| Iram Cancer Research ( Site 0198) | Santiago | Region M. de Santiago | 7630370 | Chile |
| Oncocentro ( Site 0195) | Viña del Mar | Valparaiso | Chile |
| Anhui Provincial Hospital ( Site 1029) | Hefei | Anhui | 230001 | China |
| Anhui Provincial Cancer Hospital ( Site 1007) | Hefei | Anhui | 230031 | China |
| Peking Union Medical College Hospital ( Site 1001) | Beijing | Beijing Municipality | 100730 | China |
| Chongqing Cancer Hospital ( Site 1030) | Chongqing | Chongqing Municipality | 400030 | China |
| The First Affiliated Hospital of Xiamen University ( Site 1025) | Xiamen | Fujian | 361003 | China |
| The First Affiliated Hospital.Sun Yat-sen University ( Site 1005) | Guangzhou | Guangdong | 510080 | China |
| Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036) | Nanning | Guangxi | 530021 | China |
| Harbin Medical University Cancer Hospital ( Site 1013) | Harbin | Heilongjiang | 150081 | China |
| Hunan Cancer Hospital ( Site 1015) | Changsha | Hunan | 233004 | China |
| Xiangya Hospital Central-South University ( Site 1009) | Changsha | Hunan | 410008 | China |
| Shanghai Cancer Hospital ( Site 1000) | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039) | Shanghai | Shanghai Municipality | 201204 | China |
| Sichuan Cancer Hospital ( Site 1018) | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital of Xinjiang Medical University ( Site 1012) | Ürümqi | Xinjiang | 830054 | China |
| Zhejiang Provincial People's Hospital ( Site 1021) | Hangzhou | Zhejiang | 310014 | China |
| Zhejiang Cancer Hospital ( Site 1004) | Hangzhou | Zhejiang | 310022 | China |
| Fundacion Centro de Investigacion Clinica CIC ( Site 0231) | Medellín | Antioquia | 050021 | Colombia |
| Instituto Nacional de Cancerologia E.S.E ( Site 0228) | Bogotá | Bogota D.C. | 110321 | Colombia |
| Fundacion Valle del Lili ( Site 0230) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Centro Medico Imbanaco de Cali S.A ( Site 0227) | Cali | Valle del Cauca Department | 760042 | Colombia |
| Fakultni Nemocnice Brno Bohunice ( Site 0912) | Brno | Brno-mesto | 602 00 | Czechia |
| Fakultni nemocnice Ostrava ( Site 0909) | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady ( Site 0913) | Prague | 100 34 | Czechia |
| CHU Jean Minjoz ( Site 0411) | Besançon | Doubs | 25000 | France |
| Institut Claudius Regaud ( Site 0417) | Toulouse | Haute-Garonne | 31059 | France |
| Centre Hospitalier Lyon Sud ( Site 0413) | Pierre-Bénite | Rhone | 69310 | France |
| Universitaetsklinikum Freiburg ( Site 0454) | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443) | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Klinikum der Universitaet in Muenchen ( Site 0446) | Munich | Bavaria | 80336 | Germany |
| Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453) | Munich | Bavaria | 81675 | Germany |
| Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452) | Dresden | Saxony | 01307 | Germany |
| Universitaetsklinik Leipzig ( Site 0456) | Leipzig | Saxony | 04103 | Germany |
| Charite Universitaetsmedizin Berlin ( Site 0442) | Berlin | 13353 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf ( Site 0445) | Hamburg | 20246 | Germany |
| General Hospital of Patras. St Andrews ( Site 0473) | Pátrai | Achaia | 262 00 | Greece |
| Alexandra General Hospital ( Site 0477) | Athens | Attica | 11528 | Greece |
| Hospital Hygeia ( Site 0478) | Athens | Attica | 151 23 | Greece |
| Euromedica General Clinic of Thessaloniki ( Site 0474) | Thessaloniki | 546 45 | Greece |
| Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321) | Guatemala City | 01010 | Guatemala |
| Oncologika S.A. ( Site 0323) | Guatemala City | 01010 | Guatemala |
| Oncomedica ( Site 0320) | Guatemala City | 01010 | Guatemala |
| Grupo Angeles SA ( Site 0319) | Guatemala City | 01015 | Guatemala |
| Medi-K Cayala ( Site 0318) | Guatemala City | 01016 | Guatemala |
| Centro Medico Integral De Cancerología (CEMIC) ( Site 0322) | Quetzaltenango | 09002 | Guatemala |
| Orszagos Onkologiai Intezet ( Site 0846) | Budapest | 1122 | Hungary |
| Debreceni Egyetem Klinikai Kozpont ( Site 0845) | Debrecen | 4032 | Hungary |
| Cork University Hospital ( Site 0504) | Cork | T12 DC4A | Ireland |
| St James Hospital ( Site 0505) | Dublin | D8 | Ireland |
| Rambam Medical Center ( Site 0815) | Haifa | 3109601 | Israel |
| Hadassah Medical Center. Ein Kerem ( Site 0816) | Jerusalem | 9112001 | Israel |
| Chaim Sheba Medical Center ( Site 0814) | Ramat Gan | 5262000 | Israel |
| Sourasky Medical Center ( Site 0819) | Tel Aviv | 6423906 | Israel |
| Istituto Europeo di Oncologia ( Site 0536) | Milan | Milano | 20141 | Italy |
| Istituto di Candiolo - IRCCS ( Site 0546) | Candiolo | Piedmont | 10060 | Italy |
| Istituto Nazionale Tumori Regina Elena ( Site 0540) | Rome | Roma | 00144 | Italy |
| A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541) | Bologna | 40138 | Italy |
| Ospedale Vito Fazzi ( Site 0547) | Lecce | 73100 | Italy |
| IRCCS Ospedale San Raffaele ( Site 0539) | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542) | Milan | 20133 | Italy |
| Fondazione Giovanni Pascale Di Napoli ( Site 0544) | Naples | 80131 | Italy |
| Policlinico Universitario Gemelli ( Site 0538) | Roma | 00168 | Italy |
| A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535) | Torino | 10126 | Italy |
| Aichi Cancer Center Hospital ( Site 1155) | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East ( Site 1159) | Kashiwa | Chiba | 2778577 | Japan |
| National Hospital Organization Shikoku Cancer Center ( Site 1162) | Matsuyama | Ehime | 791-0280 | Japan |
| Ehime University Hospital ( Site 1157) | Tōon | Ehime | 790-0295 | Japan |
| Kurume University Hospital ( Site 1164) | Kurume | Fukuoka | 830-0011 | Japan |
| Hokkaido University Hospital ( Site 1163) | Sapporo | Hokkaido | 060-8648 | Japan |
| Iwate Medical University Hospital ( Site 1165) | Shiwa-gun | Iwate | 028-3695 | Japan |
| University of the Ryukyus Hospital ( Site 1156) | Nakagami-gun | Okinawa | 903-0215 | Japan |
| Saitama Medical University International Medical Center ( Site 1168) | Hidaka | Saitama | 350-1298 | Japan |
| Saitama Cancer Center ( Site 1169) | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Kyorin University Hospital ( Site 1158) | Mitaka | Tokyo | 181-8611 | Japan |
| National Hospital Organization Kyushu Cancer Center ( Site 1167) | Fukuoka | 811-1395 | Japan |
| Kagoshima City Hospital ( Site 1166) | Kagoshima | 890-8760 | Japan |
| Osaka International Cancer Institute ( Site 1161) | Osaka | 541-8567 | Japan |
| National Cancer Center Hospital ( Site 1172) | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171) | Tokyo | 135-8550 | Japan |
| Keio University Hospital ( Site 1170) | Tokyo | 160-8582 | Japan |
| Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601) | Bergen | Hordaland | 5021 | Norway |
| Oslo Universitetssykehus Radiumhospitalet ( Site 0600) | Oslo | 0379 | Norway |
| Centro Medico Monte Carmelo ( Site 0289) | Arequipa | Ariqipa | 04001 | Peru |
| Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287) | Trujillo | La Libertad | 13013 | Peru |
| Clinica San Gabriel ( Site 0296) | San Miguel | Lima region | 15087 | Peru |
| Hospital Nacional Daniel Alcides Carrion ( Site 0293) | Callao | Lima | 07021 | Peru |
| Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290) | Lima | 15036 | Peru |
| Hospital Nacional Arzobispo Loayza ( Site 0292) | Lima | 15082 | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291) | Lima | 15082 | Peru |
| Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741) | Chelyabinsk | Chelyabinsk Oblast | 454087 | Russia |
| Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729) | Krasnoyarsk | Krasnoyarsk Krai | 660133 | Russia |
| MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722) | Moscow | Moscow | 125284 | Russia |
| GBUZ SPb CRPCstmc(o) ( Site 0746) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734) | Yaroslavl | Yaroslavl Oblast | 150054 | Russia |
| National Cancer Center ( Site 1065) | Goyang-si | Kyonggi-do | 10408 | South Korea |
| Asan Medical Center ( Site 1062) | Seoul | Seoul | 05505 | South Korea |
| Keimyung University Dongsan Medical Center ( Site 1066) | Daegu | Taegu-Kwangyokshi | 42601 | South Korea |
| Severance Hospital ( Site 1063) | Seoul | 03722 | South Korea |
| Samsung Medical Center ( Site 1064) | Seoul | 06351 | South Korea |
| Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637) | Badalona | Barcelona | 08916 | Spain |
| Hosp Clin Univ de Santiago ( Site 0629) | Santiago de Compostela | La Coruna | 15706 | Spain |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638) | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitari Vall d Hebron ( Site 0634) | Barcelona | 08035 | Spain |
| Complejo Hospitalario de Jaen ( Site 0632) | Jaén | 23007 | Spain |
| Hospital Clinico Universitario Lozano Blesa ( Site 0630) | Zaragoza | 50009 | Spain |
| Karolinska Universitetssjukhuset ( Site 0784) | Stockholm | Stockholm County | 171 76 | Sweden |
| National Taiwan University Hospital ( Site 1095) | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital ( Site 1094) | Taipei | 104 | Taiwan |
| Linkou Chang Gung Memorial Hospital ( Site 1097) | Taoyuan | 333 | Taiwan |
| Ramathibodi Hospital, Mahidol University ( Site 1131) | Rajthevee | Bangkok | 10400 | Thailand |
| Srinagarind Hospital. Khon Kaen University ( Site 1132) | Mueang | Changwat Khon Kaen | 40002 | Thailand |
| Songklanagarind Hospital ( Site 1130) | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital ( Site 1133) | Chiang Mai | 50200 | Thailand |
| I.U. Cerrahpasa Medical Faculty ( Site 0755) | Istanbul | Istanbul | 34093 | Turkey (Türkiye) |
| Acibadem Adana Hastanesi ( Site 0756) | Adana | 01130 | Turkey (Türkiye) |
| Baskent Universitesi Ankara Hastanesi ( Site 0754) | Ankara | 06490 | Turkey (Türkiye) |
| Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876) | Kharkiv | Kharkiv Oblast | 61024 | Ukraine |
| Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882) | Lviv | Lviv Oblast | 79031 | Ukraine |
| Royal Devon and Exeter Foundation Trust Hospital ( Site 0699) | Exeter | England | United Kingdom |
| ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701) | London | London, City of | SW3 6JJ | United Kingdom |
| Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696) | London | Surrey | SM3 5PT | United Kingdom |
| Result |
| Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Cvek J, Randall L, Pereira de Santana Gomes AJ, Contreras Mejia F, Helpman L, Akilli H, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Colombo N, Chang CL, Bednarikova M, Zhu H, Oaknin A, Christiaens M, Petru E, Usami T, Liu P, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Oct 5;404(10460):1321-1332. doi: 10.1016/S0140-6736(24)01808-7. Epub 2024 Sep 14. |
| 40592026 | Derived | Randall L, Xiang Y, Matsumoto T, Giannarelli D, Milla DP, Lopez KA, Acevedo A, Vizkeleti J, Salani R, Nogueira-Rodrigues A, Mejia FC, Korach J, Akilli H, Lee JY, Saevets VV, Samouelian V, Sehouli J, Tharavichikul E, Sukhin V, Colombo N, Chang CL, Cueva JF, Lalondrelle S, Petru E, Szamreta E, Nguyen AM, Yamada K, Li K, Pignata S, Lorusso D. Patient-reported outcomes from the phase 3, randomized, double-blind, placebo-controlled ENGOT-cx11/GOG-3047/KEYNOTE-A18 study of pembrolizumab plus concurrent chemoradiotherapy in participants with high-risk locally advanced cervical cancer. Gynecol Oncol. 2025 Aug;199:88-95. doi: 10.1016/j.ygyno.2025.06.003. Epub 2025 Jun 30. |
| Plain Language Summary | View source |
| FG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemoradiotherapy + Pembrolizumab | Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
| BG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
| BG002 | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| PDL-1 Status | Programmed cell death ligand 1 (PDL-1) status based on combined positive score (CPS) indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS<1 and CPS ≥1 at baseline is presented. Participants with CS <1 were classified as PD-L1 negative, and participants with CPS ≥1 were classified as PD-L1 positive. | 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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. | All randomized participants analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 55 months |
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| Primary | Overall Survival (OS) | OS is the time from randomization to death due to any cause. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate OS. | All randomized participants analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 55 months |
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| Secondary | PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. | All randomized participants analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 55 months |
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| Secondary | PFS Per RECIST 1.1 at Month 24 as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by the investigator is presented. | All randomized participants analyzed in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 months |
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| Secondary | PFS Per RECIST 1.1 at Month 24 as Assessed by BICR | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by BICR is presented. | All randomized participants analyzed in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 months |
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| Secondary | Overall Survival (OS) at Month 36 | OS is the time from randomization to death due to any cause. The analysis was performed via Kaplan-Meier approach to estimate the OS rate at Month 36. The percentage of participants with OS at Month 36 is presented. | All randomized participants analyzed in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 36 months |
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| Secondary | Complete Response (CR) Rate Per RECIST 1.1 at Week 12 as Assessed by the Investigator | For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. The percentage of participants with CR per RECIST 1.1 as assessed by the investigator at Week 12 is presented. | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
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| Secondary | CR Rate Per RECIST 1.1 at Week 12 as Assessed by BICR | For participants who demonstrated a confirmed CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. The percentage of participants with CR per RECIST 1.1 as assessed by BICR at Week 12 is presented. | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
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| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by the Investigator | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 55 months |
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| Secondary | ORR Per RECIST 1.1 as Assessed by BICR | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 55 months |
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| Secondary | PFS Per RECIST 1.1 in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PD-L1 positive participants have a combined positivity score (CPS) equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. | All randomized participants analyzed in the treatment group to which they were randomized. PD-L1 positive participants were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 55 months |
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| Secondary | PFS Per RECIST 1.1 in PD-L1 Positive Participants as Assessed by BICR | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PD-L1 positive participants have a CPS equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. | All randomized participants analyzed in the treatment group to which they were randomized. PD-L1 positive participants were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 55 months |
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| Secondary | OS in PD-L1 Positive Participants | OS is the time from randomization to death due to any cause. PD-L1 positive participants have a CPS equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate OS. | All randomized participants analyzed in the treatment group to which they were randomized. PD-L1 positive participants were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 55 months |
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| Secondary | PFS After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment | PFS is defined as the time from randomization to the first documented progressive disease (PD) on next-line treatment or death due to any cause, whichever occurs first, as assessed by the investigator. PFS 2 is measured after next-line treatment following discontinuation of study treatment administration. | All randomized participants analyzed in the treatment group to which they were randomized | Posted | Median | 95% Confidence Interval | Months | Up to approximately 55 months |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score | The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented. | Randomized participants who have at least 1 patient reported outcome (PRO) assessment for QLQ-C30 available and have received at least 1 dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and week 36 |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented. | Randomized participants who have at least 1 PRO assessment for QLQ-C30 available and have received at least 1 dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and week 36 |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score | The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. Total scores are linearly transformed and range from 0 (no symptoms) to 100 (most severe symptoms). The change from baseline in EORTC QLQ-CX24 score is presented, with negative scores representing an improvement from baseline and vice versa. | Randomized participants who have at least 1 PRO assessment for QLQ-CX24 available and have received at least 1 dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 36 |
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| Secondary | Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | All randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 55 months |
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| Secondary | Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | All randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 32 months |
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All-cause mortality (ACM): from allocation up to a maximum of 55 months. Adverse events (AEs): from start of treatment up to a maximum of 55 months.
The ACM population were allocated participants; the AE population were treated participants. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
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 + CCRT | Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). | 107 | 529 | 175 | 528 | 528 | 528 |
| EG001 | Placebo + CCRT | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). | 140 | 531 | 153 | 530 | 525 | 530 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
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| Glucocorticoid deficiency | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
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| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Autoimmune colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated gastritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal stenosis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute cholecystitis necrotic | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Intrauterine infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyometra | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Toxic shock syndrome streptococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Radiation proctitis | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract stoma complication | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Urostomy complication | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine perforation | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Vascular access complication | 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 |
| |
| Blood corticotrophin decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| C-reactive protein 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 |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Transaminases increased | 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 |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Electrolyte imbalance | 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 |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendix cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour associated fever | 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 |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Stent malfunction | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Autoimmune nephritis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ureteral cyst | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ureteric dilatation | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urogenital fistula | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine fistula | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal perforation | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vulval disorder | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | 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 |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue 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 |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular 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 |
| |
| Lymphopenia | 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 |
| |
| Tinnitus | Ear and labyrinth 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 |
| |
| Abdominal pain upper | 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 |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Radiation skin injury | 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 |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase 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 |
| |
| SARS-CoV-2 test positive | 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 |
| |
| Hyponatraemia | 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 |
| |
| 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 |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal 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 |
| |
| Hot flush | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Disclosure | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Nov 24, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| CPS>=1 |
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| Missing |
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| OG001 |
| Chemoradiotherapy + Placebo for Pembrolizumab |
Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| Chemoradiotherapy + Placebo for Pembrolizumab |
Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 |
| Chemoradiotherapy + Placebo for Pembrolizumab |
Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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| OG001 | Chemoradiotherapy + Placebo for Pembrolizumab | Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays). |
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