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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05173987




Registration number
NCT05173987
Ethics application status
Date submitted
20/12/2021
Date registered
30/12/2021

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
Scientific title
A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)
Secondary ID [1] 0 0
MK-3475-C93
Secondary ID [2] 0 0
3475-C93
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - pembrolizumab
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel
Treatment: Drugs - docetaxel
Treatment: Drugs - cisplatin

Experimental: Pembrolizumab - Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (up to approximately 2 years).

Active comparator: Carboplatin+paclitaxel - Participants receive a combination of paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m\^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m\^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation.


Treatment: Other: pembrolizumab
Intravenous (IV) infusion

Treatment: Drugs: carboplatin
IV infusion

Treatment: Drugs: paclitaxel
IV infusion

Treatment: Drugs: docetaxel
IV infusion

Treatment: Drugs: cisplatin
IV infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 45 months
Primary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Up to approximately 59 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 45 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [2] 0 0
Up to approximately 45 months
Secondary outcome [3] 0 0
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [3] 0 0
Up to approximately 45 months
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Timepoint [4] 0 0
Up to approximately 45 months
Secondary outcome [5] 0 0
Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Timepoint [5] 0 0
Up to approximately 45 months
Secondary outcome [6] 0 0
Number of Participants Who Experience at Least One Adverse Event (AE)
Timepoint [6] 0 0
Up to approximately 27 months
Secondary outcome [7] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [7] 0 0
Up to approximately 24 months
Secondary outcome [8] 0 0
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score
Timepoint [8] 0 0
Baseline and up to approximately 25 months
Secondary outcome [9] 0 0
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score
Timepoint [9] 0 0
Baseline and up to approximately 25 months

Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:



* Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
* Has received no prior systemic therapy for EC except for the following:

1. May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurrence occurred =6 months after the last dose of chemotherapy.
2. May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
3. May have received prior hormonal therapy for treatment of EC, provided that it was discontinued =1 week prior to randomization.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
* Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).
* Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.
* Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.
* If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.
* If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
* Has EC of any histology that is proficient mismatch repair (pMMR).
* Is a candidate for curative-intent surgery or curative-intent radiotherapy.
* 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 coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]).
* Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.
* Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
* Has known active CNS metastases and/or carcinomatous meningitis.
* Has a known intolerance to any study intervention and/or any of its excipients.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection, requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has had an allogenic tissue/solid organ transplant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2027
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Northern Cancer Institute ( Site 0206) - St Leonards
Recruitment hospital [2] 0 0
Westmead Hospital-Department of Gynaecological Oncology ( Site 0201) - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
Recruitment hospital [4] 0 0
Monash Health ( Site 0202) - Clayton
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207) - Melbourne
Recruitment hospital [6] 0 0
Epworth Freemasons ( Site 0203) - Melbourne
Recruitment hospital [7] 0 0
St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204) - Subiaco
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment postcode(s) [7] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Mississippi
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New Jersey
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New York
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United States of America
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North Carolina
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North Dakota
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United States of America
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Ohio
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United States of America
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Oregon
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Pennsylvania
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South Dakota
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United States of America
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Texas
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United States of America
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Virginia
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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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Brazil
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Rio Grande Do Norte
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Canada
State/province [32] 0 0
Saskatchewan
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Chile
State/province [33] 0 0
Region M. De Santiago
Country [34] 0 0
China
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Anhui
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China
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Beijing
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China
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Chongqing
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Hainan
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shaanxi
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China
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Shandong
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China
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Shanghai
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Sichuan
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China
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Tianjin
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China
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Yunnan
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China
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Zhejiang
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Czechia
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Brno-mesto
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Czechia
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Moravskoslezsky Kraj
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Czechia
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Novy Jicin
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Czechia
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Olomoucky Kraj
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Czechia
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Praha 2
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Czechia
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Praha 8
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Czechia
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Zlinsky Kraj
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Czechia
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Praha 10
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Denmark
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Hovedstaden
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Denmark
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Nordjylland
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Denmark
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Sjaelland
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Finland
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Pirkanmaa
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Finland
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Pohjois-Savo
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Finland
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Uusimaa
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Germany
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Baden-Wurttemberg
Country [70] 0 0
Germany
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Nordrhein-Westfalen
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Germany
State/province [71] 0 0
Sachsen
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Germany
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Berlin
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Hungary
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Budapest
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Ireland
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Cork
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Ireland
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Dublin
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Israel
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Be'er Sheva
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Israel
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Haifa
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Israel
State/province [78] 0 0
Holon
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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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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Roma
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Italy
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Toscana
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Italy
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Veneto
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Italy
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Milano
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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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Fukuoka
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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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Ibaraki
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Japan
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Iwate
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Japan
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Niigata
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Osaka
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Korea, Republic of
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Seoul
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Netherlands
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Gelderland
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Netherlands
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Limburg
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Zuid-Holland
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Netherlands
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Groningen
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Netherlands
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Utrecht
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New Zealand
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Auckland
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Norway
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Oslo
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Poland
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Lubelskie
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Poland
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Mazowieckie
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Poland
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Podlaskie
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Poland
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Slaskie
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Poland
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Swietokrzyskie
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Poland
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Wielkopolskie
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Moskovskaya Oblast
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Yaroslavskaya Oblast
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
La Coruna
Country [122] 0 0
Spain
State/province [122] 0 0
Madrid, Comunidad De
Country [123] 0 0
Spain
State/province [123] 0 0
Navarra
Country [124] 0 0
Spain
State/province [124] 0 0
Valenciana, Comunitat
Country [125] 0 0
Spain
State/province [125] 0 0
Sevilla
Country [126] 0 0
Sweden
State/province [126] 0 0
Skane Lan
Country [127] 0 0
Sweden
State/province [127] 0 0
Stockholms Lan
Country [128] 0 0
Sweden
State/province [128] 0 0
Vasterbottens Lan
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taichung
Country [130] 0 0
Taiwan
State/province [130] 0 0
Tainan
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taipei
Country [132] 0 0
Turkey
State/province [132] 0 0
Istanbul
Country [133] 0 0
Turkey
State/province [133] 0 0
Ankara
Country [134] 0 0
Turkey
State/province [134] 0 0
Antalya
Country [135] 0 0
United Kingdom
State/province [135] 0 0
England
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Glasgow City
Country [137] 0 0
United Kingdom
State/province [137] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
GOG Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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/NCT05173987