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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03740165
Registration number
NCT03740165
Ethics application status
Date submitted
12/11/2018
Date registered
14/11/2018
Titles & IDs
Public title
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
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Scientific title
A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
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Secondary ID [1]
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0
ENGOT-ov43
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Secondary ID [2]
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7339-001
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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:
Ovarian Cancer
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0
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Fallopian Tube Cancer
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0
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Peritoneal Neoplasms
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Ovarian and primary peritoneal
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Cancer
0
0
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0
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Womb (Uterine or endometrial cancer)
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Cancer
0
0
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0
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Placebo for pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Olaparib
Treatment: Drugs - Placebo for olaparib
Treatment: Other - Bevacizumab
Treatment: Drugs - Docetaxel
Experimental: Pembrolizumab + Olaparib - Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Experimental: Pembrolizumab + Placebo for Olaparib - Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Active comparator: Placebo for Pembrolizumab + Placebo for Olaparib - Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Treatment: Other: Pembrolizumab
IV infusion
Treatment: Drugs: Placebo for pembrolizumab
IV infusion
Treatment: Drugs: Carboplatin
IV infusion
Treatment: Drugs: Paclitaxel
IV infusion
Treatment: Drugs: Olaparib
Oral tablet
Treatment: Drugs: Placebo for olaparib
Oral tablet
Treatment: Other: Bevacizumab
IV infusion
Treatment: Drugs: Docetaxel
IV infusion
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Intervention code [1]
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Treatment: Other
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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 the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]=10)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment 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. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1-positive (CPS=10) tumors.
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Timepoint [1]
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Up to approximately 57 months
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Primary outcome [2]
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PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
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Assessment method [2]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment 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. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants.
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Timepoint [2]
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Up to approximately 57 months
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Secondary outcome [1]
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Overall Survival (OS) in All Participants
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Assessment method [1]
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OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
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Timepoint [1]
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Up to approximately 6 years
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Secondary outcome [2]
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OS in Participants with PDL-1 Positive Tumors (CPS = 10)
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Assessment method [2]
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OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants with PD-L1 positive tumors (CPS=10).
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [3]
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PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants with PD-L1-Positive Tumors (CPS=10)
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Assessment method [3]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment 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. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for participants with PD-L1-positive (CPS=10) tumors.
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Timepoint [3]
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0
Up to approximately 57 months
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Secondary outcome [4]
0
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PFS Per RECIST 1.1 as Assessed by BICR in All Participants
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Assessment method [4]
0
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment 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. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for all participants.
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Timepoint [4]
0
0
Up to approximately 57 months
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Secondary outcome [5]
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PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants with PD-L1-Positive Tumors (CPS=10)
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Assessment method [5]
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PFS2 is defined as the time from randomization until PD (clinical or radiological) after second-line treatment or death due to any cause, whichever occurs first. The PFS2 per Investigator assessment will be reported for participants with PD-L1-positive (CPS=10) tumors.
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Timepoint [5]
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Up to approximately 78 months
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Secondary outcome [6]
0
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PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants
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Assessment method [6]
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PFS2 is defined as the time from randomization until PD (clinical or radiological) after second-line treatment or death due to any cause, whichever occurs first. The PFS2 per Investigator assessment will be reported for all participants.
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Timepoint [6]
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Up to approximately 78 months
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Secondary outcome [7]
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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [7]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
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Timepoint [7]
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Up to approximately 73 months
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Secondary outcome [8]
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Number of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [8]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
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Timepoint [8]
0
0
Up to approximately 6 years
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Secondary outcome [9]
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Mean Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) Score Using Questions from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
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Assessment method [9]
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Participants are asked to answer 2 questions from the EORTC QLQ-C30 about their GHS: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Responses are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status. The mean change from baseline in GHS/QoL score of participants will be reported.
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Timepoint [9]
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Baseline and End of Study Participation (Up to approximately 6 years)
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Secondary outcome [10]
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Mean Change from Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
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Assessment method [10]
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Participants are asked to answer 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence and stomach fullness when eating. Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better abdominal/GI symptoms. The mean change from baseline in abdominal/GI symptom score of participants will be reported.
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Timepoint [10]
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Baseline and End of Study Participation (Up to approximately 6 years)
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Secondary outcome [11]
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Time to deterioration (TTD) of GHS/QoL score using EORTC QLQ-C30
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Assessment method [11]
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Participants are asked to answer 2 questions from the EORTC QLQ-C30 about their GHS: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Responses are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status. TTD is defined as the time from the first GHS/QoL assessment to deterioration (defined as =10-point decrease in GHS/QoL score from baseline) or death, whichever occurs first. The TTD in GHS/QoL score of participants will be reported.
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Timepoint [11]
0
0
Up to approximately 6 years
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Secondary outcome [12]
0
0
Time to deterioration (TTD) of abdominal/GI symptoms using EORTC QLQ-OV28
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Assessment method [12]
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Participants are asked to answer 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence and stomach fullness when eating. Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better abdominal/GI symptoms. TTD is defined as the time from the first EORTC QLQ-OV28 assessment to deterioration (defined as =10-point decrease in EORTC QLQ-OV28 score from baseline) or death, whichever occurs first. The TTD in abdominal/GI symptom score of participants will be reported.
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Timepoint [12]
0
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Up to approximately 6 years
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Secondary outcome [13]
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Time to First Subsequent Anti-cancer Treatment (TFST)
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Assessment method [13]
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TFST is defined as the time from randomization to initiation of first subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TFST will be reported.
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Timepoint [13]
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Up to approximately 6 years
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Secondary outcome [14]
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Time to Second Subsequent Anti-cancer Treatment (TSST)
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Assessment method [14]
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TSST is defined as the time from randomization to initiation of second subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TSST will be reported.
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Timepoint [14]
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Up to approximately 6 years
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Secondary outcome [15]
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Time to Discontinuation of Study Treatment or Death (TDT)
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Assessment method [15]
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TDT is defined as the time from the date of randomization to discontinuation of study treatment or death due to any cause, whichever occurs first. The TDT will be reported.
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Timepoint [15]
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Up to approximately 6 years
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Secondary outcome [16]
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Pathological Complete Response (pCR) Rate
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Assessment method [16]
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pCR is defined as all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The pCR rate for all surgical specimens will be reported.
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Timepoint [16]
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Up to approximately 30 months
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Eligibility
Key inclusion criteria
* Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
* Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery
* Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
* Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
* Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1
* Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy 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. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* 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
* Has mucinous, germ cell, or borderline tumor of the ovary
* Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
* Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
* Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
* Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded.
* Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period
* Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >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 the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: 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 known history of active tuberculosis (TB; Bacillus Tuberculosis)
* Has an active infection requiring systemic therapy
* Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period
* Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
* Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study
* Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption)
* Has uncontrolled hypertension
* Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab)
* Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab)
* Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy
* Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy)
* Has received prior therapy with an anti-Programmed Cell Death-1 (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 antigen-4 [CTLA-4], OX 40, CD137)
* Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor
* Has intraperitoneal chemotherapy planned or has been administered as first-line therapy
* Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1
* Has severe hypersensitivity (=Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and/or any of their excipients
* Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
* Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
* Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period
* Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome
* Has had an allogenic tissue/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation
* Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery
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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 administering 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
18/12/2018
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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
29/05/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
1367
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St George Hospital ( Site 2207) - Kogarah
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Recruitment hospital [2]
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Cairns and Hinterland Hospital and Health Service ( Site 2201) - Cairns
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Recruitment hospital [3]
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Ballarat Health Services ( Site 2202) - Ballarat
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Recruitment hospital [4]
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Monash Health ( Site 2204) - Clayton
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Recruitment hospital [5]
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Sunshine Hospital. ( Site 2205) - St Albans
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4870 - Cairns
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Recruitment postcode(s) [3]
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3350 - Ballarat
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3021 - St Albans
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Alabama
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0
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Arizona
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0
United States of America
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California
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0
United States of America
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0
0
Connecticut
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0
0
United States of America
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0
0
Florida
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0
0
United States of America
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State/province [6]
0
0
Georgia
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0
0
United States of America
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0
0
Illinois
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0
0
United States of America
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0
0
Indiana
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0
0
United States of America
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0
0
Iowa
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0
0
United States of America
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State/province [10]
0
0
Kentucky
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0
0
United States of America
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State/province [11]
0
0
Maryland
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0
0
United States of America
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State/province [12]
0
0
Mississippi
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0
0
United States of America
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State/province [13]
0
0
Missouri
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Nebraska
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Country [15]
0
0
United States of America
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State/province [15]
0
0
New Hampshire
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0
0
United States of America
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State/province [16]
0
0
New Jersey
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0
0
United States of America
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State/province [17]
0
0
New York
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Country [18]
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Ohio
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United States of America
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Texas
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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Bruxelles-Capitale, Region De
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Belgium
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Hainaut
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Belgium
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Liege
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Belgium
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Brazil
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Goias
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Brazil
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Parana
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Brazil
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Rio Grande Do Sul
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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Chile
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Cesar
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Cordoba
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Colombia
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Distrito Capital De Bogota
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Colombia
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Valle Del Cauca
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Brno-mesto
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Moravskoslezsky Kraj
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Czechia
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Praha, Hlavni Mesto
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Olomouc
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Auvergne
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France
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Gard
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France
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Loire
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France
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France
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Paris
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Bayern
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Nordrhein-Westfalen
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Germany
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Germany
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Hungary
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Baranya
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Hungary
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Borsod-Abauj-Zemplen
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Hungary
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Budapest
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Hungary
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Debrecen
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Israel
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Beer-Sheva
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Holon
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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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Abruzzo
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Veneto
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Italy
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Benevento
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Italy
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Catania
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Italy
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Lecco
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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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Italy
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Trento
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Italy
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Udine
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Iwate
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Japan
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Kanagawa
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Japan
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Okinawa
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Kagoshima
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Japan
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Niigata
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Japan
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Osaka
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Korea, Republic of
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Kyonggi-do
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Seoul
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Poland
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Mazowieckie
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Podlaskie
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Slaskie
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Wielkopolskie
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Russian Federation
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Arkhangel Skaya Oblast
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Russian Federation
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Russian Federation
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Kaluzskaja Oblast
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Russian Federation
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Moskva
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Eastern Cape
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Gauteng
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South Africa
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Western Cape
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Spain
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Barcelona
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La Coruna
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Spain
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Valenciana, Comunitat
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Spain
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Caceres
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Sevilla
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Changhua
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Taoyuan
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Istanbul
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Bursa
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Sakarya
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Ukraine
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Khmelnytska Oblast
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Ukraine
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Lvivska Oblast
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Ukraine
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Odeska Oblast
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Ukraine
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Sumska Oblast
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Ukraine
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Zakarpatska Oblast
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Ukraine
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Kyiv
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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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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
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Address [1]
0
0
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0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
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0
Gynecologic Oncology Group
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0
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0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel\* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score \[CPS\]=10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS=10) and in all participants.
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Trial website
https://clinicaltrials.gov/study/NCT03740165
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
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Address
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0
Merck Sharp & Dohme LLC
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Country
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0
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Phone
0
0
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Fax
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0
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Email
0
0
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Contact person for public queries
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0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03740165