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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03635567
Registration number
NCT03635567
Ethics application status
Date submitted
15/08/2018
Date registered
17/08/2018
Date last updated
17/01/2024
Titles & IDs
Public title
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
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Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)
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Secondary ID [1]
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MK-3475-826
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Secondary ID [2]
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3475-826
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pembrolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Other interventions - Bevacizumab
Treatment: Drugs - Placebo to pembrolizumab
Experimental: Pembrolizumab+Chemotherapy - On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Placebo Comparator: Placebo+Chemotherapy - On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Other interventions: Pembrolizumab
IV infusion
Treatment: Drugs: Paclitaxel
IV infusion
Treatment: Drugs: Cisplatin
IV infusion
Treatment: Drugs: Carboplatin
IV infusion
Other interventions: Bevacizumab
IV infusion
Treatment: Drugs: Placebo to pembrolizumab
IV infusion
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) =1
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Assessment method [1]
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PFS was 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 was defined as = 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS =1 is presented.
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Timepoint [1]
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Up to approximately 46 months
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Primary outcome [2]
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PFS Per RECIST 1.1 as Assessed by Investigator in All Participants
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Assessment method [2]
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PFS was 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 was defined as = 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.
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Timepoint [2]
0
0
Up to approximately 46 months
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Primary outcome [3]
0
0
PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS =10
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Assessment method [3]
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PFS was 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 was defined as = 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS =10 is presented.
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Timepoint [3]
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Up to approximately 46 months
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Primary outcome [4]
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Overall Survival (OS) in Participants With PD-L1 CPS =1
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Assessment method [4]
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OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS =1 is presented.
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Timepoint [4]
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Up to approximately 46 months
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Primary outcome [5]
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OS in All Participants
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Assessment method [5]
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OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.
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Timepoint [5]
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Up to approximately 46 months
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Primary outcome [6]
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OS in Participants With PD-L1 CPS =10
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Assessment method [6]
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OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS =10 is presented.
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Timepoint [6]
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Up to approximately 46 months
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Secondary outcome [1]
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Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
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Assessment method [1]
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ORR was defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator is presented.
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Timepoint [1]
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Up to approximately 46 months
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Secondary outcome [2]
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Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
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Assessment method [2]
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For participants who demonstrate CR or PR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator is presented.
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Timepoint [2]
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Up to approximately 46 months
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Secondary outcome [3]
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Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator
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Assessment method [3]
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PFS was 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 was defined as = 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS Rate was defined as the percentage of participants that were PFS event-free at Month 12. The PFS Rate per RECIST 1.1 as assessed by Investigator at Month 12 is presented.
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Timepoint [3]
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12 months
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Secondary outcome [4]
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PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [4]
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PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as = 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by BICR is presented.
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Timepoint [4]
0
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Up to approximately 46 months
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Secondary outcome [5]
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Number of Participants Who Experienced an Adverse Event (AE)
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Assessment method [5]
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An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is presented.
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Timepoint [5]
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Up to approximately 46 months
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Secondary outcome [6]
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Number of Participants Who Experienced a Serious AE (SAE)
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Assessment method [6]
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An SAE was defined as any untoward medical occurrence that, at any dose: a.) Resulted in death; b.) Was life-threatening; c.) Required inpatient hospitalization or prolongation of existing hospitalization; d.) Resulted in persistent or significant disability/incapacity; e.) Was a congenital anomaly/birth defect; f.) Other important medical events; h.) Was a new cancer (that is not a condition of the study) or i.) Was associated with an overdose. The number of participants who experienced an SAE is presented.
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Timepoint [6]
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Up to approximately 46 months
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Secondary outcome [7]
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Number of Participants Who Experienced an Immune-related AE (irAE)
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Assessment method [7]
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AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs included, but were not limited to: -Pneumonitis;
Diarrhea/Colitis;
Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin;
Type 1 diabetes mellitus or Hyperglycemia;
Hypophysitis;
Hyperthyroidism;
Hypothyroidism;
Nephritis and Renal dysfunction; and
Myocarditis. The number of participants who experienced an irAE is presented.
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Timepoint [7]
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Up to approximately 46 months
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Secondary outcome [8]
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Number of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [8]
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The number of participants who discontinued study treatment due to an AE is presented.
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Timepoint [8]
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Up to approximately 43 months
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Secondary outcome [9]
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Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score
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Assessment method [9]
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The EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. Participant responses to "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Raw scores are standardized with linear transformation so that scores range from 0-100. A higher combined score indicates a better overall health status. Participant post-baseline scores were classified based on change from baseline, "Improved": a =10-point improvement in score and confirmed by the next visit; "Stable": a =10-point increase or <10-point change in score OR a <10-point change in score and a =10-point increase in score at the next visit; or "Deteriorated": a =10-point deterioration in score when the criteria for improvement/stability weren't met. Participants who didn't meet "Improved", "Stable", or "Deteriorated" criteria reported as "Other".
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Timepoint [9]
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Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months
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Eligibility
Key inclusion criteria
- Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous
carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic
chemotherapy and is not amenable to curative treatment (such as with surgery and/or
radiation). Prior chemotherapy utilized as a radiosensitizing agent and completed at
least 2 weeks prior to randomization with resolution of all treatment-related
toxicities is allowed. AEs due to previous treatments should be resolved to = Grade 1
or baseline. Participants with = Grade 2 neuropathy or = Grade 2 alopecia are
eligible.
- Not pregnant or breastfeeding, and at least one of the following conditions applies:
a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use
effective contraception during the treatment period and for at least 120 days after
the last dose of pembrolizumab/placebo and 210 days after the last dose of
chemotherapy/bevacizumab
- Has measurable disease per RECIST 1.1 as assessed by the local site
investigator/radiology
- Has provided archival tumor tissue sample or newly obtained core or excisional biopsy
of a tumor lesion not previously irradiated for prospective determination of
Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within
14 days prior to randomization
- Has adequate organ function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Participants with known brain metastases may participate provided that the
brain metastases have been previously treated (except with chemotherapy) and are
radiographically stable.
- Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years. Note: Participants with basal cell carcinoma of the skin,
squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer,
or carcinoma in situ (e.g. breast cancer) that have undergone potentially curative
therapy are not excluded.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in doses exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to randomization
- Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) is not considered a form
of systemic treatment and is allowed
- 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 known history of active tuberculosis (TB; Bacillus tuberculosis)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.
cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137)
- Has received prior systemic chemotherapy for treatment of cervical cancer.
- Has not recovered adequately from toxicity and/or complications from major surgery
prior to randomization
- Has received prior radiotherapy within 2 weeks prior to randomization. Participants
must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis.
- Has received a live vaccine within 30 days prior to randomization
- Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
- Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin,
paclitaxel, or bevacizumab
- 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
- Is pregnant or breastfeeding or expecting to conceive within the projected duration of
the study, starting with the screening visit through 120 days following last dose of
pembrolizumab/placebo and 210 days following last dose of chemotherapy/bevacizumab
- Has had an allogeneic tissue/solid organ transplant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
4/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
617
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Royal North Shore Hospital ( Site 1514) - St Leonards
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Recruitment hospital [2]
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Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521) - South Brisbane
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Recruitment hospital [3]
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Flinders Medical Centre ( Site 1513) - Bedford Park
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Recruitment hospital [4]
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St John of God Subiaco Hospital ( Site 1512) - Subiaco
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Recruitment hospital [5]
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Monash Health-Monash Medical Centre ( Site 1519) - Clayton
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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6008 - Subiaco
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment outside Australia
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Alaska
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Michigan
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Missouri
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New York
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Ohio
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Oklahoma
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South Carolina
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Tennessee
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Texas
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Washington
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Argentina
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Buenos Aires
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Argentina
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La Rioja
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Argentina
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Tucuman
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Alberta
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Canada
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Manitoba
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Nova Scotia
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Ontario
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Chile
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Valparaiso
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Chile
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Santiago
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Chile
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Temuco
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Colombia
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Cesar
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Valle
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Colombia
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Barranquilla
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Colombia
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Monteria
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Colombia
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Pasto
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France
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Clermont Ferrand
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France
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Marseille
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France
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Paris
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France
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Rennes
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France
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Saint-Cloud
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Germany
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Dresden
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Germany
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Duesseldorf
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Muenchen
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Germany
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Oldenburg
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Germany
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Regensburg
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Aviano
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Italy
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Bolgna
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Italy
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Milano
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Italy
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Napoli
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Italy
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Roma
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Japan
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Chiba
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Japan
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Ehime
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Country [62]
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Iwate
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Japan
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Okinawa
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Country [67]
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Japan
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Saitama
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Country [68]
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Japan
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Shizuoka
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Country [69]
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Japan
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State/province [69]
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Tokyo
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Country [70]
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Yucatan
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Mexico
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Chihuahua
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Mexico
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Ciudad de Mexico
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Mexico
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Mexico
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Country [76]
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Mexico
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San Pedro Garza Garcia
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Mexico
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Veracruz
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Country [78]
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Peru
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La Libertad
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Country [79]
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Peru
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State/province [79]
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Arequipa
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Country [80]
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Peru
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Lima
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Country [81]
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Russian Federation
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Kazan
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Country [82]
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saransk
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Russian Federation
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St. Petersburg
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Country [87]
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Russian Federation
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Tomsk
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Russian Federation
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Ufa
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Spain
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Guipuzcoa
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Spain
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Madrid
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Spain
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Badalona
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Spain
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Sevilla
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Taiwan
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State/province [93]
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Kaohsiung
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Taiwan
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State/province [94]
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Taichung
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Taiwan
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State/province [95]
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Taipei
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Country [96]
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Taiwan
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State/province [96]
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Taoyuan
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Country [97]
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Turkey
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Adana
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Country [98]
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Konya
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Ukraine
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Dnipropetrovsk
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Country [104]
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Country [106]
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Ukraine
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Kyiv
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Country [107]
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Ukraine
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State/province [107]
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Odesa
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Country [108]
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Ukraine
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Zaporizhzhya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475)
plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of
placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women
with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens
include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus
carboplatin with or without bevacizumab.
The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is
superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per
Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator,
or, 2) Overall Survival (OS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03635567
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03635567
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