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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04221945
Other study ID # 3475-A18
Secondary ID MK-3475-A18KEYNO
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 12, 2020
Est. completion date January 17, 2025

Study information

Verified date February 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 980
Est. completion date January 17, 2025
Est. primary completion date January 17, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage IB2-IIB (with node-positive disease) or FIGO 2014 Stages III-IVA - Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix - Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and is immunotherapy-naïve - Female participants must not be pregnant or breastfeeding and agree to use highly effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. - Female participants must abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment - Has provided a tissue sample from a core incisional or excisional biopsy of a tumor lesion - Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the local site investigator/radiology - Has adequate organ function within 7 days prior to the start of study treatment. Exclusion Criteria: - Has excluded subtypes of LACC - Has FIGO 2014 Stage IVB disease - Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy - Has bilateral hydronephrosis, unless at least one side has been stented or resolved by positioning of nephrostomy or considered mild and not clinically significant in the opinion of the investigator - Has anatomy or tumor geometry or any other reason or contraindication that cannot be treated with intracavitary brachytherapy or a combination of intracavitary and interstitial brachytherapy - Has received a live vaccine within 30 days prior to the first dose of study treatment - Has received treatment with systemic immunostimulatory agents, colony stimulating factors, interferons, interleukins and vaccine combinations within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1 - Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137) - Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization - Has any contraindication to the use of cisplatin - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years - Has severe hypersensitivity to pembrolizumab and/or any of its excipients - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has an active infection requiring systemic therapy - Has a known history of Human Immunodeficiency Virus (HIV) infection - Has a known history of Hepatitis B or known active Hepatitis C virus infection - Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study - Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study - Has had an allogenic tissue/solid organ transplant - Has evidence of metastatic disease per RECIST 1.1 including lymph nodes above the first lumbar vertebra (L1) cephalad body, in the inguinal region

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Pembrolizumab
IV infusion
Drug:
Placebo for pembrolizumab
IV infusion
Cisplatin
IV infusion
Radiation:
External Beam Radiotherapy (EBRT)
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Brachytherapy
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Locations

Country Name City State
Australia Monash Health-Monash Medical Centre ( Site 0970) Clayton Victoria
Australia Royal Brisbane and Women s Hospital ( Site 0972) Herston Queensland
Australia Peter MacCallum Cancer Centre ( Site 0971) Melbourne Victoria
Australia St John of God Subiaco Hospital ( Site 0969) Subiaco Western Australia
Australia Westmead Hospital ( Site 0973) Westmead New South Wales
Austria Medizinische Universitat Graz ( Site 0569) Graz Steiermark
Austria Medizinische Universitat Innsbruck ( Site 0566) Innsbruck Tirol
Austria Medizinische Universität Wien ( Site 0567) Vienna Wien
Belgium OLV Ziekenhuis ( Site 0352) Aalst Oost-Vlaanderen
Belgium UZA University Hospital Antwerp ( Site 0351) Edegem Antwerpen
Belgium AZ St Lucas ( Site 0349) Gent Oost-Vlaanderen
Belgium UZ Leuven ( Site 0354) Leuven Vlaams-Brabant
Belgium C.I.U. Hopital Ambroise Pare ( Site 0353) Mons Hainaut
Belgium GZA Sint Augustinus ( Site 0356) Wilrijk Antwerpen
Brazil Hospital das Clinicas da UFMG ( Site 0172) Belo Horizonte Minas Gerais
Brazil Liga Norte Riograndense Contra o Cancer ( Site 0170) Natal Rio Grande Do Norte
Brazil Hospital de Clínicas de Ribeirão Preto ( Site 0171) Ribeirão Preto Sao Paulo
Brazil Instituto Nacional Do Cancer II ( Site 0173) Rio de Janeiro
Brazil Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166) São Paulo Sao Paulo
Canada Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101) Montreal Quebec
Canada McGill University Health Centre ( Site 0105) Montreal Quebec
Canada Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 Quebec City Quebec
Canada Princess Margaret Cancer Centre ( Site 0102) Toronto Ontario
Chile Iram Cancer Research ( Site 0198) Santiago Region M. De Santiago
Chile Sociedad Oncovida S.A. ( Site 0196) Santiago Region M. De Santiago
Chile Centro Investigación del Cáncer James Lind ( Site 0194) Temuco Araucania
Chile Oncocentro ( Site 0195) Vina del Mar Valparaiso
China Peking Union Medical College Hospital ( Site 1001) Beijing Beijing
China Hunan Cancer Hospital ( Site 1015) Changsha Hunan
China Xiangya Hospital Central-South University ( Site 1009) Changsha Hunan
China Sichuan Cancer Hospital ( Site 1018) Chengdu Sichuan
China Chongqing Cancer Hospital ( Site 1030) Chongqing Chongqing
China The First Affiliated Hospital.Sun Yat-sen University ( Site 1005) Guangzhou Guangdong
China Zhejiang Cancer Hospital ( Site 1004) Hangzhou Zhejiang
China Zhejiang Provincial People's Hospital ( Site 1021) Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital ( Site 1013) Harbin Heilongjiang
China Anhui Provincial Cancer Hospital ( Site 1007) Hefei Anhui
China Anhui Provincial Hospital ( Site 1029) Hefei Anhui
China Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036) Nanning Guangxi
China Shanghai Cancer Hospital ( Site 1000) Shanghai Shanghai
China Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039) Shanghai Shanghai
China The First Affiliated Hospital of Xinjiang Medical University ( Site 1012) Urumqi Xinjiang
China The First Affiliated Hospital of Xiamen University ( Site 1025) Xiamen Fujian
Colombia Instituto Nacional de Cancerologia E.S.E ( Site 0228) Bogota Distrito Capital De Bogota
Colombia Centro Medico Imbanaco de Cali S.A ( Site 0227) Cali Valle Del Cauca
Colombia Fundacion Valle del Lili ( Site 0230) Cali Valle Del Cauca
Colombia Fundacion Centro de Investigacion Clinica CIC ( Site 0231) Medellin Antioquia
Czechia Fakultni Nemocnice Brno Bohunice ( Site 0912) Brno Brno-mesto
Czechia Fakultni nemocnice Ostrava ( Site 0909) Ostrava Moravskoslezsky Kraj
Czechia Fakultni nemocnice Kralovske Vinohrady ( Site 0913) Praha 10
France CHU Jean Minjoz ( Site 0411) Besancon Doubs
France Centre Hospitalier Lyon Sud ( Site 0413) Pierre Benite Rhone
France Institut Claudius Regaud ( Site 0417) Toulouse Haute-Garonne
Germany Charite Universitaetsmedizin Berlin ( Site 0442) Berlin
Germany Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452) Dresden Sachsen
Germany Universitaetsklinikum Freiburg ( Site 0454) Freiburg Baden-Wurttemberg
Germany Universitaetsklinikum Hamburg-Eppendorf ( Site 0445) Hamburg
Germany Universitaetsklinik Leipzig ( Site 0456) Leipzig Sachsen
Germany Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443) Mannheim Baden-Wurttemberg
Germany Klinikum der Universitaet in Muenchen ( Site 0446) Muenchen Bayern
Germany Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453) Muenchen Bayern
Greece Alexandra General Hospital ( Site 0477) Athens Attiki
Greece Hospital Hygeia ( Site 0478) Athens Attiki
Greece General Hospital of Patras. St Andrews ( Site 0473) Patras Achaia
Greece Euromedica General Clinic of Thessaloniki ( Site 0474) Thessaloniki
Guatemala Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321) Guatemala
Guatemala Grupo Angeles SA ( Site 0319) Guatemala
Guatemala Medi-K Cayala ( Site 0318) Guatemala
Guatemala Oncologika S.A. ( Site 0323) Guatemala
Guatemala Oncomedica ( Site 0320) Guatemala
Guatemala Centro Medico Integral De Cancerología (CEMIC) ( Site 0322) Quetzaltenango
Hungary Orszagos Onkologiai Intezet ( Site 0846) Budapest
Hungary Debreceni Egyetem Klinikai Kozpont ( Site 0845) Debrecen
Ireland Cork University Hospital ( Site 0504) Cork
Ireland St James Hospital ( Site 0505) Dublin
Israel Rambam Medical Center ( Site 0815) Haifa
Israel Hadassah Medical Center. Ein Kerem ( Site 0816) Jerusalem
Israel Chaim Sheba Medical Center ( Site 0814) Ramat Gan
Israel Sourasky Medical Center ( Site 0819) Tel Aviv
Italy A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541) Bologna
Italy Istituto di Candiolo - IRCCS ( Site 0546) Candiolo Piemonte
Italy Ospedale Vito Fazzi ( Site 0547) Lecce
Italy Istituto Europeo di Oncologia ( Site 0536) Milan Milano
Italy Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542) Milano
Italy IRCCS Ospedale San Raffaele ( Site 0539) Milano
Italy Fondazione Giovanni Pascale Di Napoli ( Site 0544) Napoli
Italy Policlinico Universitario Gemelli ( Site 0538) Roma
Italy Istituto Nazionale Tumori Regina Elena ( Site 0540) Rome Roma
Italy A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535) Torino
Japan National Hospital Organization Kyushu Cancer Center ( Site 1167) Fukuoka
Japan Saitama Medical University International Medical Center ( Site 1168) Hidaka Saitama
Japan Kagoshima City Hospital ( Site 1166) Kagoshima
Japan National Cancer Center Hospital East ( Site 1159) Kashiwa Chiba
Japan Saitama Cancer Center ( Site 1169) Kitaadachi-gun Saitama
Japan Kurume University Hospital ( Site 1164) Kurume Fukuoka
Japan National Hospital Organization Shikoku Cancer Center ( Site 1162) Matsuyama Ehime
Japan Kyorin University Hospital ( Site 1158) Mitaka Tokyo
Japan Aichi Cancer Center Hospital ( Site 1155) Nagoya Aichi
Japan University of the Ryukyus Hospital ( Site 1156) Nakagami-gun Okinawa
Japan Osaka International Cancer Institute ( Site 1161) Osaka
Japan Hokkaido University Hospital ( Site 1163) Sapporo Hokkaido
Japan Iwate Medical University Hospital ( Site 1165) Shiwa-gun Iwate
Japan Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171) Tokyo
Japan Keio University Hospital ( Site 1170) Tokyo
Japan National Cancer Center Hospital ( Site 1172) Tokyo
Japan Ehime University Hospital ( Site 1157) Toon Ehime
Korea, Republic of Keimyung University Dongsan Medical Center ( Site 1066) Daegu Taegu-Kwangyokshi
Korea, Republic of National Cancer Center ( Site 1065) Goyang-si Kyonggi-do
Korea, Republic of Samsung Medical Center ( Site 1064) Seoul
Korea, Republic of Severance Hospital ( Site 1063) Seoul
Korea, Republic of Asan Medical Center ( Site 1062) Seoul. Seoul
Norway Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601) Bergen Hordaland
Norway Oslo Universitetssykehus Radiumhospitalet ( Site 0600) Oslo
Peru Centro Medico Monte Carmelo ( Site 0289) Arequipa Ariqipa
Peru Hospital Nacional Daniel Alcides Carrion ( Site 0293) Callao Lima
Peru Hospital Nacional Arzobispo Loayza ( Site 0292) Lima
Peru Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291) Lima
Peru Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290) Lima
Peru Clinica San Gabriel ( Site 0296) San Miguel Lima
Peru Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287) Trujillo La Libertad
Russian Federation Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741) Chelyabinsk Chelyabinskaya Oblast
Russian Federation Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729) Krasnoyarsk Krasnoyarskiy Kray
Russian Federation MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722) Moscow Moskva
Russian Federation GBUZ SPb CRPCstmc(o) ( Site 0746) Saint Petersburg Sankt-Peterburg
Russian Federation National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725) St. Petersburg Sankt-Peterburg
Russian Federation Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734) Yaroslavl Yaroslavskaya Oblast
Spain Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637) Badalona Barcelona
Spain Hospital Universitari Vall d Hebron ( Site 0634) Barcelona
Spain Complejo Hospitalario de Jaen ( Site 0632) Jaen
Spain HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638) Pozuelo de Alarcon Madrid
Spain Hosp Clin Univ de Santiago ( Site 0629) Santiago de Compostela La Coruna
Spain Hospital Clinico Universitario Lozano Blesa ( Site 0630) Zaragoza
Sweden Karolinska Universitetssjukhuset ( Site 0784) Stockholm Stockholms Lan
Taiwan Mackay Memorial Hospital ( Site 1094) Taipei
Taiwan National Taiwan University Hospital ( Site 1095) Taipei
Taiwan Linkou Chang Gung Memorial Hospital ( Site 1097) Taoyuan
Thailand Maharaj Nakorn Chiang Mai Hospital ( Site 1133) Chiang Mai
Thailand Songklanagarind Hospital ( Site 1130) Hatyai Songkhla
Thailand Srinagarind Hospital. Khon Kaen University ( Site 1132) Mueang Khon Kaen
Thailand Ramathibodi Hospital, Mahidol University ( Site 1131) Rajthevee Krung Thep Maha Nakhon
Turkey Acibadem Adana Hastanesi ( Site 0756) Adana
Turkey Baskent Universitesi Ankara Hastanesi ( Site 0754) Ankara
Turkey I.U. Cerrahpasa Medical Faculty ( Site 0755) Istambul Istanbul
Ukraine Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876) Kharkiv Kharkivska Oblast
Ukraine Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882) Lviv Lvivska Oblast
United Kingdom Royal Devon and Exeter Foundation Trust Hospital ( Site 0699) Exeter England
United Kingdom ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701) London London, City Of
United Kingdom Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696) London Surrey
United States University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019) Albuquerque New Mexico
United States Texas Oncology-Austin Central ( Site 8006) Austin Texas
United States Our Lady of the Lake Regional Medical Center. ( Site 0031) Baton Rouge Louisiana
United States Sanford Bismarck Medical Center ( Site 0046) Bismarck North Dakota
United States University of North Carolina at Chapel Hill ( Site 0025) Chapel Hill North Carolina
United States Hollings Cancer Center ( Site 0007) Charleston South Carolina
United States UVA Health System ( Site 0005) Charlottesville Virginia
United States The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C Columbus Ohio
United States Women's Cancer Care ( Site 0039) Covington Louisiana
United States University of Colorado Health Sciences Center and Hospital ( Site 0028) Denver Colorado
United States Karmanos Cancer Institute ( Site 0018) Detroit Michigan
United States Willamette Valley Cancer Institute and Research Center ( Site 8000) Eugene Oregon
United States Parkview Research Center at Parkview Regional Medical Center ( Site 0026) Fort Wayne Indiana
United States Texas Oncology-Fort Worth Cancer Center ( Site 8001) Fort Worth Texas
United States University of Kentucky Markey Cancer Center ( Site 0015) Lexington Kentucky
United States UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027) Los Angeles California
United States Minnesota Oncology Hematology, PA ( Site 8007) Minneapolis Minnesota
United States Smilow Cancer Center at Yale-New Haven ( Site 0023) New Haven Connecticut
United States Hoag Memorial Hospital Presbyterian ( Site 0038) Newport Beach California
United States AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009) Orlando Florida
United States HonorHealth Research Institute - Biltmore ( Site 8009) Phoenix Arizona
United States Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030) Pittsburgh Pennsylvania
United States Legacy Good Samaritan Medical Center ( Site 0013) Portland Oregon
United States Virginia Commonwealth University ( Site 0024) Richmond Virginia
United States UC Davis Comprehensive Cancer Center ( Site 0017) Sacramento California
United States Texas Oncology-San Antonio Medical Center ( Site 8002) San Antonio Texas
United States Sanford Gynecology Oncology ( Site 0003) Sioux Falls South Dakota
United States Texas Oncology-The Woodlands ( Site 8003) The Woodlands Texas

Sponsors (3)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Czechia,  France,  Germany,  Greece,  Guatemala,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Peru,  Russian Federation,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
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. Up to approximately 38 months
Primary Overall Survival (OS) OS is the time from randomization to death due to any cause. Up to approximately 46 months
Secondary Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (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. Up to approximately 38 months
Secondary Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (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. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 38 months. Up to approximately 38 months
Secondary Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 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. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 38 months. Up to approximately 38 months
Secondary Overall Survival (OS) at Month 36 OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 36 using the entire OS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 46 months. Up to approximately 46 months
Secondary Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (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. CR data will be cumulated to a certain cut-off date and the analysis will be performed to estimate the CR rate at Week 12 using the entire CR data up to the cut-off date. The cut-off date is estimated to be approximately 38 months. Up to approximately 38 months
Secondary Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12 as Assessed by Blinded Independent Central Review (BICR) 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. CR data will be cumulated to a certain cut-off date and the analysis will be performed to estimate the CR rate at Week 12 using the entire CR data up to the cut-off date. The cut-off date is estimated to be approximately 38 months. Up to approximately 38 months
Secondary Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (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 46 months
Secondary Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (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 46 months
Secondary Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (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. Up to approximately 38 months
Secondary Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants 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. Up to approximately 38 months
Secondary Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator OS is the time from randomization to death due to any cause. Up to approximately 46 months
Secondary Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR) OS is the time from randomization to death due to any cause. Up to approximately 46 months
Secondary Progression-Free Survival (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. Up to approximately 46 months
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. Baseline and up to approximately 46 months
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. Baseline and up to approximately 46 months
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. The change from baseline in EORTC QLQ-CX24 score will be presented. Baseline and up to approximately 46 months
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. Up to approximately 46 months
Secondary Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (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 approximately 46 months
See also
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Active, not recruiting NCT04947605 - Epidemiological Landscape of Cervical Cancer in Latin America