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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04221945




Registration number
NCT04221945
Ethics application status
Date submitted
23/12/2019
Date registered
9/01/2020
Date last updated
10/05/2021

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2019-003152-37
Secondary ID [2] 0 0
3475-A18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Cervical Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pembrolizumab
Treatment: Drugs - Placebo for pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Other - External Beam Radiotherapy (EBRT)
Treatment: Other - Brachytherapy

Experimental: chemoradiotherapy + pembrolizumab - 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).

Experimental: chemoradiotherapy + placebo for pembrolizumab - 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).


Other interventions: Pembrolizumab
IV infusion

Treatment: Drugs: Placebo for pembrolizumab
IV infusion

Treatment: Drugs: Cisplatin
IV infusion

Treatment: Other: External Beam Radiotherapy (EBRT)
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 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.
Timepoint [1] 0 0
Up to approximately 38 months
Primary outcome [2] 0 0
Overall Survival (OS) - OS is the time from randomization to death due to any cause.
Timepoint [2] 0 0
Up to approximately 46 months
Secondary outcome [1] 0 0
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, or by histopathologic confirmation of 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.
Timepoint [1] 0 0
Up to approximately 38 months
Secondary outcome [2] 0 0
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 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.
Timepoint [2] 0 0
Up to approximately 38 months
Secondary outcome [3] 0 0
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, or by histopathologic confirmation of 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.
Timepoint [3] 0 0
Up to approximately 38 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to approximately 46 months
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to approximately 38 months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Up to approximately 38 months
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Up to approximately 46 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Up to approximately 46 months
Secondary outcome [9] 0 0
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 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.
Timepoint [9] 0 0
Up to approximately 38 months
Secondary outcome [10] 0 0
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, or by histopathologic confirmation of 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.
Timepoint [10] 0 0
Up to approximately 38 months
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Up to approximately 46 months
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Up to approximately 46 months
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Up to approximately 46 months
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Baseline and up to approximately 46 months
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Baseline and up to approximately 46 months
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
Baseline and up to approximately 46 months
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
Up to approximately 46 months
Secondary outcome [18] 0 0
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.
Timepoint [18] 0 0
Up to approximately 46 months

Eligibility
Key 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

- 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 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 within 7 days prior to the start of study treatment
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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 that required steroids or has current
pneumonitis

- 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital ( Site 0973) - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane and Women s Hospital ( Site 0972) - Herston
Recruitment hospital [3] 0 0
Monash Health-Monash Medical Centre ( Site 0970) - Clayton
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre ( Site 0971) - Melbourne
Recruitment hospital [5] 0 0
St John of God Subiaco Hospital ( Site 0969) - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
North Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Austria
State/province [18] 0 0
Tirol
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Belgium
State/province [20] 0 0
Antwerpen
Country [21] 0 0
Belgium
State/province [21] 0 0
Hainaut
Country [22] 0 0
Belgium
State/province [22] 0 0
Oost-Vlaanderen
Country [23] 0 0
Brazil
State/province [23] 0 0
Minas Gerais
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande Do Norte
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio de Janeiro
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Chile
State/province [29] 0 0
Araucania
Country [30] 0 0
Chile
State/province [30] 0 0
Region M. De Santiago
Country [31] 0 0
Chile
State/province [31] 0 0
Valparaiso
Country [32] 0 0
China
State/province [32] 0 0
Anhui
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Chongqing
Country [35] 0 0
China
State/province [35] 0 0
Fujian
Country [36] 0 0
China
State/province [36] 0 0
Guangdong
Country [37] 0 0
China
State/province [37] 0 0
Guangxi
Country [38] 0 0
China
State/province [38] 0 0
Heilongjiang
Country [39] 0 0
China
State/province [39] 0 0
Hunan
Country [40] 0 0
China
State/province [40] 0 0
Shanghai
Country [41] 0 0
China
State/province [41] 0 0
Sichuan
Country [42] 0 0
China
State/province [42] 0 0
Xinjiang
Country [43] 0 0
China
State/province [43] 0 0
Zhejiang
Country [44] 0 0
Colombia
State/province [44] 0 0
Antioquia
Country [45] 0 0
Colombia
State/province [45] 0 0
Distrito Capital De Bogota
Country [46] 0 0
Colombia
State/province [46] 0 0
Valle Del Cauca
Country [47] 0 0
Czechia
State/province [47] 0 0
Brno-mesto
Country [48] 0 0
Czechia
State/province [48] 0 0
Moravskoslezsky Kraj
Country [49] 0 0
Czechia
State/province [49] 0 0
Praha 10
Country [50] 0 0
France
State/province [50] 0 0
Haute-Garonne
Country [51] 0 0
France
State/province [51] 0 0
Rhone
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Guatemala
State/province [53] 0 0
Guatemala
Country [54] 0 0
Guatemala
State/province [54] 0 0
Quetzaltenango
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Debrecen
Country [57] 0 0
Ireland
State/province [57] 0 0
Cork
Country [58] 0 0
Israel
State/province [58] 0 0
Tell Abib
Country [59] 0 0
Israel
State/province [59] 0 0
Haifa
Country [60] 0 0
Israel
State/province [60] 0 0
Jerusalem
Country [61] 0 0
Israel
State/province [61] 0 0
Ramat Gan
Country [62] 0 0
Italy
State/province [62] 0 0
Milano
Country [63] 0 0
Italy
State/province [63] 0 0
Piemonte
Country [64] 0 0
Italy
State/province [64] 0 0
Roma
Country [65] 0 0
Italy
State/province [65] 0 0
Bologna
Country [66] 0 0
Italy
State/province [66] 0 0
Lecce
Country [67] 0 0
Italy
State/province [67] 0 0
Napoli
Country [68] 0 0
Italy
State/province [68] 0 0
Torino
Country [69] 0 0
Japan
State/province [69] 0 0
Aichi
Country [70] 0 0
Japan
State/province [70] 0 0
Ehime
Country [71] 0 0
Japan
State/province [71] 0 0
Fukuoka
Country [72] 0 0
Japan
State/province [72] 0 0
Hokkaido
Country [73] 0 0
Japan
State/province [73] 0 0
Iwate
Country [74] 0 0
Japan
State/province [74] 0 0
Okinawa
Country [75] 0 0
Japan
State/province [75] 0 0
Saitama
Country [76] 0 0
Japan
State/province [76] 0 0
Tokyo
Country [77] 0 0
Japan
State/province [77] 0 0
Kagoshima
Country [78] 0 0
Japan
State/province [78] 0 0
Osaka
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Kyonggi-do
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Seoul
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Taegu-Kwangyokshi
Country [82] 0 0
Norway
State/province [82] 0 0
Hordaland
Country [83] 0 0
Norway
State/province [83] 0 0
Oslo
Country [84] 0 0
Peru
State/province [84] 0 0
Ariqipa
Country [85] 0 0
Peru
State/province [85] 0 0
La Libertad
Country [86] 0 0
Peru
State/province [86] 0 0
Lima
Country [87] 0 0
Peru
State/province [87] 0 0
Muni Metro De Lima
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Chelyabinskaya Oblast
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Krasnoyarskiy Kray
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Moskva
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Sankt-Peterburg
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Yaroslavskaya Oblast
Country [93] 0 0
Spain
State/province [93] 0 0
La Coruna
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Jaen
Country [96] 0 0
Sweden
State/province [96] 0 0
Stockholms Lan
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taipei
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taoyuan
Country [99] 0 0
Thailand
State/province [99] 0 0
Chiang Mai
Country [100] 0 0
Thailand
State/province [100] 0 0
Krung Thep Maha Nakhon
Country [101] 0 0
Turkey
State/province [101] 0 0
Istanbul
Country [102] 0 0
Turkey
State/province [102] 0 0
Adana
Country [103] 0 0
Turkey
State/province [103] 0 0
Ankara
Country [104] 0 0
Ukraine
State/province [104] 0 0
Kharkivska Oblast

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Network for Gynaecological Oncological Trial Groups
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Gynecologic Oncology Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04221945
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04221945