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Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Primary Purpose

Uterine Cervical Neoplasms

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab

Placebo for pembrolizumab

Cisplatin

External Beam Radiotherapy (EBRT)

Brachytherapy

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Programmed Cell Death Receptor 1 (PD-1, PD1), Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1), Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

HonorHealth Research Institute - Biltmore ( Site 8009)
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)
Hoag Memorial Hospital Presbyterian ( Site 0038)
UC Davis Comprehensive Cancer Center ( Site 0017)
University of Colorado Health Sciences Center and Hospital ( Site 0028)
Smilow Cancer Center at Yale-New Haven ( Site 0023)
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)
Parkview Research Center at Parkview Regional Medical Center ( Site 0026)
University of Kentucky Markey Cancer Center ( Site 0015)
Our Lady of the Lake Regional Medical Center. ( Site 0031)
Women's Cancer Care ( Site 0039)
Karmanos Cancer Institute ( Site 0018)
Minnesota Oncology Hematology, PA ( Site 8007)
University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)
University of North Carolina at Chapel Hill ( Site 0025)
Sanford Bismarck Medical Center ( Site 0046)
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Willamette Valley Cancer Institute and Research Center ( Site 8000)
Legacy Good Samaritan Medical Center ( Site 0013)
Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)
Hollings Cancer Center ( Site 0007)
Sanford Gynecology Oncology ( Site 0003)
Texas Oncology-Austin Central ( Site 8006)
Texas Oncology-Fort Worth Cancer Center ( Site 8001)
Texas Oncology-San Antonio Medical Center ( Site 8002)
Texas Oncology-The Woodlands ( Site 8003)
UVA Health System ( Site 0005)
Virginia Commonwealth University ( Site 0024)
Westmead Hospital ( Site 0973)
Royal Brisbane and Women s Hospital ( Site 0972)
Monash Health-Monash Medical Centre ( Site 0970)
Peter MacCallum Cancer Centre ( Site 0971)
St John of God Subiaco Hospital ( Site 0969)
Medizinische Universitat Graz ( Site 0569)
Medizinische Universitat Innsbruck ( Site 0566)
Medizinische Universität Wien ( Site 0567)
UZA University Hospital Antwerp ( Site 0351)
GZA Sint Augustinus ( Site 0356)
C.I.U. Hopital Ambroise Pare ( Site 0353)
OLV Ziekenhuis ( Site 0352)
AZ St Lucas ( Site 0349)
UZ Leuven ( Site 0354)
Hospital das Clinicas da UFMG ( Site 0172)
Liga Norte Riograndense Contra o Cancer ( Site 0170)
Hospital de Clínicas de Ribeirão Preto ( Site 0171)
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)
Instituto Nacional Do Cancer II ( Site 0173)
Princess Margaret Cancer Centre ( Site 0102)
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)
McGill University Health Centre ( Site 0105)
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Centro Investigación del Cáncer James Lind ( Site 0194)
Sociedad Oncovida S.A. ( Site 0196)
Iram Cancer Research ( Site 0198)
Oncocentro ( Site 0195)
Anhui Provincial Hospital ( Site 1029)
Anhui Provincial Cancer Hospital ( Site 1007)
Peking Union Medical College Hospital ( Site 1001)
Chongqing Cancer Hospital ( Site 1030)
The First Affiliated Hospital of Xiamen University ( Site 1025)
The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)
Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)
Harbin Medical University Cancer Hospital ( Site 1013)
Hunan Cancer Hospital ( Site 1015)
Xiangya Hospital Central-South University ( Site 1009)
Shanghai Cancer Hospital ( Site 1000)
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)
Sichuan Cancer Hospital ( Site 1018)
The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)
Zhejiang Provincial People's Hospital ( Site 1021)
Zhejiang Cancer Hospital ( Site 1004)
Fundacion Centro de Investigacion Clinica CIC ( Site 0231)
Instituto Nacional de Cancerologia E.S.E ( Site 0228)
Fundacion Valle del Lili ( Site 0230)
Centro Medico Imbanaco de Cali S.A ( Site 0227)
Fakultni Nemocnice Brno Bohunice ( Site 0912)
Fakultni nemocnice Ostrava ( Site 0909)
Fakultni nemocnice Kralovske Vinohrady ( Site 0913)
CHU Jean Minjoz ( Site 0411)
Institut Claudius Regaud ( Site 0417)
Centre Hospitalier Lyon Sud ( Site 0413)
Universitaetsklinikum Freiburg ( Site 0454)
Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)
Klinikum der Universitaet in Muenchen ( Site 0446)
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)
Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)
Universitaetsklinik Leipzig ( Site 0456)
Charite Universitaetsmedizin Berlin ( Site 0442)
Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)
General Hospital of Patras. St Andrews ( Site 0473)
Alexandra General Hospital ( Site 0477)
Hospital Hygeia ( Site 0478)
Euromedica General Clinic of Thessaloniki ( Site 0474)
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)
Oncologika S.A. ( Site 0323)
Oncomedica ( Site 0320)
Grupo Angeles SA ( Site 0319)
Medi-K Cayala ( Site 0318)
Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)
Orszagos Onkologiai Intezet ( Site 0846)
Debreceni Egyetem Klinikai Kozpont ( Site 0845)
Cork University Hospital ( Site 0504)
St James Hospital ( Site 0505)
Rambam Medical Center ( Site 0815)
Hadassah Medical Center. Ein Kerem ( Site 0816)
Chaim Sheba Medical Center ( Site 0814)
Sourasky Medical Center ( Site 0819)
Istituto Europeo di Oncologia ( Site 0536)
Istituto di Candiolo - IRCCS ( Site 0546)
Istituto Nazionale Tumori Regina Elena ( Site 0540)
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)
Ospedale Vito Fazzi ( Site 0547)
IRCCS Ospedale San Raffaele ( Site 0539)
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)
Fondazione Giovanni Pascale Di Napoli ( Site 0544)
Policlinico Universitario Gemelli ( Site 0538)
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)
Aichi Cancer Center Hospital ( Site 1155)
National Cancer Center Hospital East ( Site 1159)
National Hospital Organization Shikoku Cancer Center ( Site 1162)
Ehime University Hospital ( Site 1157)
Kurume University Hospital ( Site 1164)
Hokkaido University Hospital ( Site 1163)
Iwate Medical University Hospital ( Site 1165)
University of the Ryukyus Hospital ( Site 1156)
Saitama Medical University International Medical Center ( Site 1168)
Saitama Cancer Center ( Site 1169)
Kyorin University Hospital ( Site 1158)
National Hospital Organization Kyushu Cancer Center ( Site 1167)
Kagoshima City Hospital ( Site 1166)
Osaka International Cancer Institute ( Site 1161)
National Cancer Center Hospital ( Site 1172)
Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)
Keio University Hospital ( Site 1170)
National Cancer Center ( Site 1065)
Asan Medical Center ( Site 1062)
Keimyung University Dongsan Medical Center ( Site 1066)
Severance Hospital ( Site 1063)
Samsung Medical Center ( Site 1064)
Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)
Oslo Universitetssykehus Radiumhospitalet ( Site 0600)
Centro Medico Monte Carmelo ( Site 0289)
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)
Hospital Nacional Daniel Alcides Carrion ( Site 0293)
Clinica San Gabriel ( Site 0296)
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)
Hospital Nacional Arzobispo Loayza ( Site 0292)
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)
Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)
GBUZ SPb CRPCstmc(o) ( Site 0746)
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)
Hosp Clin Univ de Santiago ( Site 0629)
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)
Hospital Universitari Vall d Hebron ( Site 0634)
Complejo Hospitalario de Jaen ( Site 0632)
Hospital Clinico Universitario Lozano Blesa ( Site 0630)
Karolinska Universitetssjukhuset ( Site 0784)
National Taiwan University Hospital ( Site 1095)
Mackay Memorial Hospital ( Site 1094)
Linkou Chang Gung Memorial Hospital ( Site 1097)
Srinagarind Hospital. Khon Kaen University ( Site 1132)
Ramathibodi Hospital, Mahidol University ( Site 1131)
Songklanagarind Hospital ( Site 1130)
Maharaj Nakorn Chiang Mai Hospital ( Site 1133)
I.U. Cerrahpasa Medical Faculty ( Site 0755)
Acibadem Adana Hastanesi ( Site 0756)
Baskent Universitesi Ankara Hastanesi ( Site 0754)
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)
Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)
Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

chemoradiotherapy + pembrolizumab

chemoradiotherapy + placebo for pembrolizumab

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator

Overall Survival (OS)

OS is the time from randomization to death due to any cause.

Secondary Outcome Measures

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)

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.

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.

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.

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.

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)

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.

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)

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

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.

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.

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.

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.

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.

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.

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.

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

Full Information

NCT ID

NCT04221945

First Posted

December 23, 2019

Last Updated

July 18, 2023

Sponsor

Merck Sharp & Dohme LLC

Collaborators

GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)

1. Study Identification

Unique Protocol Identification Number

NCT04221945

Brief Title

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Official Title

A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 12, 2020 (Actual)

Primary Completion Date

February 7, 2024 (Anticipated)

Study Completion Date

December 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Cervical Neoplasms

Keywords

Programmed Cell Death Receptor 1 (PD-1, PD1), Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1), Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

980 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chemoradiotherapy + pembrolizumab

Arm Type

Experimental

Arm Description

Arm Title

chemoradiotherapy + placebo for pembrolizumab

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

KEYTRUDA®, MK-3475

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Placebo for pembrolizumab

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol®, Platinol®-AQ

Intervention Description

IV infusion

Intervention Type

Radiation

Intervention Name(s)

External Beam Radiotherapy (EBRT)

Intervention Description

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Intervention Type

Radiation

Intervention Name(s)

Brachytherapy

Intervention Description

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator

Description

Time Frame

Up to approximately 38 months

Title

Overall Survival (OS)

Description

OS is the time from randomization to death due to any cause.

Time Frame

Up to approximately 46 months

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

Up to approximately 38 months

Title

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

Description

Time Frame

Up to approximately 38 months

Title

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)

Description

Time Frame

Up to approximately 38 months

Title

Overall Survival (OS) at Month 36

Description

Time Frame

Up to approximately 46 months

Title

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

Description

Time Frame

Up to approximately 38 months

Title

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)

Description

Time Frame

Up to approximately 38 months

Title

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator

Description

Time Frame

Up to approximately 46 months

Title

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)

Description

Time Frame

Up to approximately 46 months

Title

Description

Time Frame

Up to approximately 38 months

Title

Description

Time Frame

Up to approximately 38 months

Title

Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator

Description

OS is the time from randomization to death due to any cause.

Time Frame

Up to approximately 46 months

Title

Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)

Description

OS is the time from randomization to death due to any cause.

Time Frame

Up to approximately 46 months

Title

Progression-Free Survival (PFS) After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment

Description

Time Frame

Up to approximately 46 months

Title

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

Description

Time Frame

Baseline and up to approximately 46 months

Title

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score

Description

Time Frame

Baseline and up to approximately 46 months

Title

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

Description

Time Frame

Baseline and up to approximately 46 months

Title

Number of Participants Who Experience One or More Adverse Events (AEs)

Description

Time Frame

Up to approximately 46 months

Title

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

Description

Time Frame

Up to approximately 46 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

HonorHealth Research Institute - Biltmore ( Site 8009)

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Hoag Memorial Hospital Presbyterian ( Site 0038)

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

UC Davis Comprehensive Cancer Center ( Site 0017)

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

University of Colorado Health Sciences Center and Hospital ( Site 0028)

City

Denver

State/Province

Colorado

ZIP/Postal Code

80262

Country

United States

Facility Name

Smilow Cancer Center at Yale-New Haven ( Site 0023)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Parkview Research Center at Parkview Regional Medical Center ( Site 0026)

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

University of Kentucky Markey Cancer Center ( Site 0015)

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Our Lady of the Lake Regional Medical Center. ( Site 0031)

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70817

Country

United States

Facility Name

Women's Cancer Care ( Site 0039)

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Karmanos Cancer Institute ( Site 0018)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Minnesota Oncology Hematology, PA ( Site 8007)

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

University of North Carolina at Chapel Hill ( Site 0025)

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Sanford Bismarck Medical Center ( Site 0046)

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Willamette Valley Cancer Institute and Research Center ( Site 8000)

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Legacy Good Samaritan Medical Center ( Site 0013)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15244

Country

United States

Facility Name

Hollings Cancer Center ( Site 0007)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Sanford Gynecology Oncology ( Site 0003)

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

Facility Name

Texas Oncology-Austin Central ( Site 8006)

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Texas Oncology-Fort Worth Cancer Center ( Site 8001)

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Texas Oncology-San Antonio Medical Center ( Site 8002)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

Facility Name

Texas Oncology-The Woodlands ( Site 8003)

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

UVA Health System ( Site 0005)

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Virginia Commonwealth University ( Site 0024)

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Westmead Hospital ( Site 0973)

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Royal Brisbane and Women s Hospital ( Site 0972)

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Monash Health-Monash Medical Centre ( Site 0970)

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Peter MacCallum Cancer Centre ( Site 0971)

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

St John of God Subiaco Hospital ( Site 0969)

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Medizinische Universitat Graz ( Site 0569)

City

Graz

State/Province

Steiermark

ZIP/Postal Code

8036

Country

Austria

Facility Name

Medizinische Universitat Innsbruck ( Site 0566)

City

Innsbruck

State/Province

Tirol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Medizinische Universität Wien ( Site 0567)

City

Vienna

State/Province

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

UZA University Hospital Antwerp ( Site 0351)

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

GZA Sint Augustinus ( Site 0356)

City

Wilrijk

State/Province

Antwerpen

ZIP/Postal Code

2610

Country

Belgium

Facility Name

C.I.U. Hopital Ambroise Pare ( Site 0353)

City

Mons

State/Province

Hainaut

ZIP/Postal Code

7000

Country

Belgium

Facility Name

OLV Ziekenhuis ( Site 0352)

City

Aalst

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9300

Country

Belgium

Facility Name

AZ St Lucas ( Site 0349)

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven ( Site 0354)

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Hospital das Clinicas da UFMG ( Site 0172)

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Liga Norte Riograndense Contra o Cancer ( Site 0170)

City

Natal

State/Province

Rio Grande Do Norte

ZIP/Postal Code

59075-740

Country

Brazil

Facility Name

Hospital de Clínicas de Ribeirão Preto ( Site 0171)

City

Ribeirão Preto

State/Province

Sao Paulo

ZIP/Postal Code

14048900

Country

Brazil

Facility Name

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Instituto Nacional Do Cancer II ( Site 0173)

City

Rio de Janeiro

ZIP/Postal Code

20220-410

Country

Brazil

Facility Name

Princess Margaret Cancer Centre ( Site 0102)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

McGill University Health Centre ( Site 0105)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Centro Investigación del Cáncer James Lind ( Site 0194)

City

Temuco

State/Province

Araucania

ZIP/Postal Code

4800827

Country

Chile

Facility Name

Sociedad Oncovida S.A. ( Site 0196)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

7510032

Country

Chile

Facility Name

Iram Cancer Research ( Site 0198)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

7630370

Country

Chile

Facility Name

Oncocentro ( Site 0195)

City

Vina del Mar

State/Province

Valparaiso

Country

Chile

Facility Name

Anhui Provincial Hospital ( Site 1029)

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230001

Country

China

Facility Name

Anhui Provincial Cancer Hospital ( Site 1007)

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230031

Country

China

Facility Name

Peking Union Medical College Hospital ( Site 1001)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Chongqing Cancer Hospital ( Site 1030)

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400030

Country

China

Facility Name

The First Affiliated Hospital of Xiamen University ( Site 1025)

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361003

Country

China

Facility Name

The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

Harbin Medical University Cancer Hospital ( Site 1013)

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150081

Country

China

Facility Name

Hunan Cancer Hospital ( Site 1015)

City

Changsha

State/Province

Hunan

ZIP/Postal Code

233004

Country

China

Facility Name

Xiangya Hospital Central-South University ( Site 1009)

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Facility Name

Shanghai Cancer Hospital ( Site 1000)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201204

Country

China

Facility Name

Sichuan Cancer Hospital ( Site 1018)

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)

City

Urumqi

State/Province

Xinjiang

ZIP/Postal Code

830054

Country

China

Facility Name

Zhejiang Provincial People's Hospital ( Site 1021)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

Facility Name

Zhejiang Cancer Hospital ( Site 1004)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Facility Name

Fundacion Centro de Investigacion Clinica CIC ( Site 0231)

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050021

Country

Colombia

Facility Name

Instituto Nacional de Cancerologia E.S.E ( Site 0228)

City

Bogota

State/Province

Distrito Capital De Bogota

ZIP/Postal Code

110321

Country

Colombia

Facility Name

Fundacion Valle del Lili ( Site 0230)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760032

Country

Colombia

Facility Name

Centro Medico Imbanaco de Cali S.A ( Site 0227)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760042

Country

Colombia

Facility Name

Fakultni Nemocnice Brno Bohunice ( Site 0912)

City

Brno

State/Province

Brno-mesto

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Fakultni nemocnice Ostrava ( Site 0909)

City

Ostrava

State/Province

Moravskoslezsky Kraj

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Fakultni nemocnice Kralovske Vinohrady ( Site 0913)

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

CHU Jean Minjoz ( Site 0411)

City

Besancon

State/Province

Doubs

ZIP/Postal Code

25000

Country

France

Facility Name

Institut Claudius Regaud ( Site 0417)

City

Toulouse

State/Province

Haute-Garonne

ZIP/Postal Code

31059

Country

France

Facility Name

Centre Hospitalier Lyon Sud ( Site 0413)

City

Pierre Benite

State/Province

Rhone

ZIP/Postal Code

69310

Country

France

Facility Name

Universitaetsklinikum Freiburg ( Site 0454)

City

Freiburg

State/Province

Baden-Wurttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)

City

Mannheim

State/Province

Baden-Wurttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

Klinikum der Universitaet in Muenchen ( Site 0446)

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80336

Country

Germany

Facility Name

Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitaetsklinik Leipzig ( Site 0456)

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Charite Universitaetsmedizin Berlin ( Site 0442)

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

General Hospital of Patras. St Andrews ( Site 0473)

City

Patras

State/Province

Achaia

ZIP/Postal Code

262 00

Country

Greece

Facility Name

Alexandra General Hospital ( Site 0477)

City

Athens

State/Province

Attiki

ZIP/Postal Code

11528

Country

Greece

Facility Name

Hospital Hygeia ( Site 0478)

City

Athens

State/Province

Attiki

ZIP/Postal Code

151 23

Country

Greece

Facility Name

Euromedica General Clinic of Thessaloniki ( Site 0474)

City

Thessaloniki

ZIP/Postal Code

546 45

Country

Greece

Facility Name

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Oncologika S.A. ( Site 0323)

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Oncomedica ( Site 0320)

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Grupo Angeles SA ( Site 0319)

City

Guatemala

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Medi-K Cayala ( Site 0318)

City

Guatemala

ZIP/Postal Code

01016

Country

Guatemala

Facility Name

Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)

City

Quetzaltenango

ZIP/Postal Code

09002

Country

Guatemala

Facility Name

Orszagos Onkologiai Intezet ( Site 0846)

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont ( Site 0845)

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Cork University Hospital ( Site 0504)

City

Cork

ZIP/Postal Code

T12 DC4A

Country

Ireland

Facility Name

St James Hospital ( Site 0505)

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Rambam Medical Center ( Site 0815)

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah Medical Center. Ein Kerem ( Site 0816)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Chaim Sheba Medical Center ( Site 0814)

City

Ramat Gan

ZIP/Postal Code

5262000

Country

Israel

Facility Name

Sourasky Medical Center ( Site 0819)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Istituto Europeo di Oncologia ( Site 0536)

City

Milan

State/Province

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Istituto di Candiolo - IRCCS ( Site 0546)

City

Candiolo

State/Province

Piemonte

ZIP/Postal Code

10060

Country

Italy

Facility Name

Istituto Nazionale Tumori Regina Elena ( Site 0540)

City

Rome

State/Province

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Ospedale Vito Fazzi ( Site 0547)

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

IRCCS Ospedale San Raffaele ( Site 0539)

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Fondazione Giovanni Pascale Di Napoli ( Site 0544)

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Policlinico Universitario Gemelli ( Site 0538)

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Aichi Cancer Center Hospital ( Site 1155)

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

National Cancer Center Hospital East ( Site 1159)

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

2778577

Country

Japan

Facility Name

National Hospital Organization Shikoku Cancer Center ( Site 1162)

City

Matsuyama

State/Province

Ehime

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

Ehime University Hospital ( Site 1157)

City

Toon

State/Province

Ehime

ZIP/Postal Code

790-0295

Country

Japan

Facility Name

Kurume University Hospital ( Site 1164)

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Hokkaido University Hospital ( Site 1163)

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Iwate Medical University Hospital ( Site 1165)

City

Shiwa-gun

State/Province

Iwate

ZIP/Postal Code

028-3695

Country

Japan

Facility Name

University of the Ryukyus Hospital ( Site 1156)

City

Nakagami-gun

State/Province

Okinawa

ZIP/Postal Code

903-0215

Country

Japan

Facility Name

Saitama Medical University International Medical Center ( Site 1168)

City

Hidaka

State/Province

Saitama

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Saitama Cancer Center ( Site 1169)

City

Kitaadachi-gun

State/Province

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Kyorin University Hospital ( Site 1158)

City

Mitaka

State/Province

Tokyo

ZIP/Postal Code

181-8611

Country

Japan

Facility Name

National Hospital Organization Kyushu Cancer Center ( Site 1167)

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Kagoshima City Hospital ( Site 1166)

City

Kagoshima

ZIP/Postal Code

890-8760

Country

Japan

Facility Name

Osaka International Cancer Institute ( Site 1161)

City

Osaka

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

National Cancer Center Hospital ( Site 1172)

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Keio University Hospital ( Site 1170)

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

National Cancer Center ( Site 1065)

City

Goyang-si

State/Province

Kyonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Asan Medical Center ( Site 1062)

City

Seoul.

State/Province

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Keimyung University Dongsan Medical Center ( Site 1066)

City

Daegu

State/Province

Taegu-Kwangyokshi

ZIP/Postal Code

42601

Country

Korea, Republic of

Facility Name

Severance Hospital ( Site 1063)

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Samsung Medical Center ( Site 1064)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)

City

Bergen

State/Province

Hordaland

ZIP/Postal Code

5021

Country

Norway

Facility Name

Oslo Universitetssykehus Radiumhospitalet ( Site 0600)

City

Oslo

ZIP/Postal Code

0379

Country

Norway

Facility Name

Centro Medico Monte Carmelo ( Site 0289)

City

Arequipa

State/Province

Ariqipa

ZIP/Postal Code

04001

Country

Peru

Facility Name

Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)

City

Trujillo

State/Province

La Libertad

ZIP/Postal Code

13013

Country

Peru

Facility Name

Hospital Nacional Daniel Alcides Carrion ( Site 0293)

City

Callao

State/Province

Lima

ZIP/Postal Code

07021

Country

Peru

Facility Name

Clinica San Gabriel ( Site 0296)

City

San Miguel

State/Province

Lima

ZIP/Postal Code

15087

Country

Peru

Facility Name

Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)

City

Lima

ZIP/Postal Code

15036

Country

Peru

Facility Name

Hospital Nacional Arzobispo Loayza ( Site 0292)

City

Lima

ZIP/Postal Code

15082

Country

Peru

Facility Name

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)

City

Lima

ZIP/Postal Code

15082

Country

Peru

Facility Name

Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)

City

Chelyabinsk

State/Province

Chelyabinskaya Oblast

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)

City

Krasnoyarsk

State/Province

Krasnoyarskiy Kray

ZIP/Postal Code

660133

Country

Russian Federation

Facility Name

MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

GBUZ SPb CRPCstmc(o) ( Site 0746)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)

City

St. Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)

City

Yaroslavl

State/Province

Yaroslavskaya Oblast

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hosp Clin Univ de Santiago ( Site 0629)

City

Santiago de Compostela

State/Province

La Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Hospital Universitari Vall d Hebron ( Site 0634)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Complejo Hospitalario de Jaen ( Site 0632)

City

Jaen

ZIP/Postal Code

23007

Country

Spain

Facility Name

Hospital Clinico Universitario Lozano Blesa ( Site 0630)

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Karolinska Universitetssjukhuset ( Site 0784)

City

Stockholm

State/Province

Stockholms Lan

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

National Taiwan University Hospital ( Site 1095)

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Mackay Memorial Hospital ( Site 1094)

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Facility Name

Linkou Chang Gung Memorial Hospital ( Site 1097)

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Srinagarind Hospital. Khon Kaen University ( Site 1132)

City

Mueang

State/Province

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Ramathibodi Hospital, Mahidol University ( Site 1131)

City

Rajthevee

State/Province

Krung Thep Maha Nakhon

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Songklanagarind Hospital ( Site 1130)

City

Hatyai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Maharaj Nakorn Chiang Mai Hospital ( Site 1133)

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

I.U. Cerrahpasa Medical Faculty ( Site 0755)

City

Istambul

State/Province

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Acibadem Adana Hastanesi ( Site 0756)

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Baskent Universitesi Ankara Hastanesi ( Site 0754)

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)

City

Kharkiv

State/Province

Kharkivska Oblast

ZIP/Postal Code

61024

Country

Ukraine

Facility Name

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)

City

Lviv

State/Province

Lvivska Oblast

ZIP/Postal Code

79031

Country

Ukraine

Facility Name

Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)

City

Exeter

State/Province

England

Country

United Kingdom

Facility Name

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)

City

London

State/Province

London, City Of

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)

City

London

State/Province

Surrey

ZIP/Postal Code

SM3 5PT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Links:

URL

https://www.merckclinicaltrials.com/

Description

Merck Clinical Trials Information

Learn more about this trial

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

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