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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)
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)
Secondary ID [1] 0 0
ENGOT-ov43
Secondary ID [2] 0 0
7339-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Peritoneal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
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
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 the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]=10)
Timepoint [1] 0 0
Up to approximately 57 months
Primary outcome [2] 0 0
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
Timepoint [2] 0 0
Up to approximately 57 months
Secondary outcome [1] 0 0
Overall Survival (OS) in All Participants
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
OS in Participants with PDL-1 Positive Tumors (CPS = 10)
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [3] 0 0
PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants with PD-L1-Positive Tumors (CPS=10)
Timepoint [3] 0 0
Up to approximately 57 months
Secondary outcome [4] 0 0
PFS Per RECIST 1.1 as Assessed by BICR in All Participants
Timepoint [4] 0 0
Up to approximately 57 months
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Up to approximately 78 months
Secondary outcome [6] 0 0
PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants
Timepoint [6] 0 0
Up to approximately 78 months
Secondary outcome [7] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [7] 0 0
Up to approximately 73 months
Secondary outcome [8] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [8] 0 0
Up to approximately 6 years
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
Baseline and End of Study Participation (Up to approximately 6 years)
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Baseline and End of Study Participation (Up to approximately 6 years)
Secondary outcome [11] 0 0
Time to deterioration (TTD) of GHS/QoL score using EORTC QLQ-C30
Timepoint [11] 0 0
Up to approximately 6 years
Secondary outcome [12] 0 0
Time to deterioration (TTD) of abdominal/GI symptoms using EORTC QLQ-OV28
Timepoint [12] 0 0
Up to approximately 6 years
Secondary outcome [13] 0 0
Time to First Subsequent Anti-cancer Treatment (TFST)
Timepoint [13] 0 0
Up to approximately 6 years
Secondary outcome [14] 0 0
Time to Second Subsequent Anti-cancer Treatment (TSST)
Timepoint [14] 0 0
Up to approximately 6 years
Secondary outcome [15] 0 0
Time to Discontinuation of Study Treatment or Death (TDT)
Timepoint [15] 0 0
Up to approximately 6 years
Secondary outcome [16] 0 0
Pathological Complete Response (pCR) Rate
Timepoint [16] 0 0
Up to approximately 30 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2026
Actual
Sample size
Target
Accrual to date
Final
1367
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St George Hospital ( Site 2207) - Kogarah
Recruitment hospital [2] 0 0
Cairns and Hinterland Hospital and Health Service ( Site 2201) - Cairns
Recruitment hospital [3] 0 0
Ballarat Health Services ( Site 2202) - Ballarat
Recruitment hospital [4] 0 0
Monash Health ( Site 2204) - Clayton
Recruitment hospital [5] 0 0
Sunshine Hospital. ( Site 2205) - St Albans
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
3350 - Ballarat
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
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Indiana
Country [9] 0 0
United States of America
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Iowa
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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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Mississippi
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Missouri
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Nebraska
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New Hampshire
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New Jersey
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New York
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Ohio
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Virginia
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Wisconsin
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Antwerpen
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Bruxelles-Capitale, Region De
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Hainaut
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Liege
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Limburg
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Ceara
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Goias
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Brazil
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Parana
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Brazil
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Araucania
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Chile
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Region M. De Santiago
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Valparaiso
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Chile
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Atlantico
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Cesar
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Cordoba
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Moravskoslezsky Kraj
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Bayern
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Sachsen
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Baranya
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Debrecen
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Holon
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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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Milano
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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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Ehime
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Gunma
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Hokkaido
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Iwate
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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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Kagoshima
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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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Korea, Republic of
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Seoul
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Poland
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Mazowieckie
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Podlaskie
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Pomorskie
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Slaskie
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Swietokrzyskie
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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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Baskortostan, Respublika
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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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Russian Federation
State/province [118] 0 0
Sankt-Peterburg
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Tatarstan, Respublika
Country [120] 0 0
South Africa
State/province [120] 0 0
Eastern Cape
Country [121] 0 0
South Africa
State/province [121] 0 0
Gauteng
Country [122] 0 0
South Africa
State/province [122] 0 0
Kwazulu-Natal
Country [123] 0 0
South Africa
State/province [123] 0 0
Western Cape
Country [124] 0 0
Spain
State/province [124] 0 0
Barcelona
Country [125] 0 0
Spain
State/province [125] 0 0
Gipuzkoa
Country [126] 0 0
Spain
State/province [126] 0 0
La Coruna
Country [127] 0 0
Spain
State/province [127] 0 0
Valenciana, Comunitat
Country [128] 0 0
Spain
State/province [128] 0 0
Caceres
Country [129] 0 0
Spain
State/province [129] 0 0
Lugo
Country [130] 0 0
Spain
State/province [130] 0 0
Madrid
Country [131] 0 0
Spain
State/province [131] 0 0
Sevilla
Country [132] 0 0
Taiwan
State/province [132] 0 0
Changhua
Country [133] 0 0
Taiwan
State/province [133] 0 0
Taichung
Country [134] 0 0
Taiwan
State/province [134] 0 0
Tainan
Country [135] 0 0
Taiwan
State/province [135] 0 0
Taipei
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taoyuan
Country [137] 0 0
Turkey
State/province [137] 0 0
Istanbul
Country [138] 0 0
Turkey
State/province [138] 0 0
Ankara
Country [139] 0 0
Turkey
State/province [139] 0 0
Antalya
Country [140] 0 0
Turkey
State/province [140] 0 0
Bursa
Country [141] 0 0
Turkey
State/province [141] 0 0
Sakarya
Country [142] 0 0
Ukraine
State/province [142] 0 0
Ivano-Frankivska Oblast
Country [143] 0 0
Ukraine
State/province [143] 0 0
Kharkivska Oblast
Country [144] 0 0
Ukraine
State/province [144] 0 0
Khmelnytska Oblast
Country [145] 0 0
Ukraine
State/province [145] 0 0
Lvivska Oblast
Country [146] 0 0
Ukraine
State/province [146] 0 0
Odeska Oblast
Country [147] 0 0
Ukraine
State/province [147] 0 0
Sumska Oblast
Country [148] 0 0
Ukraine
State/province [148] 0 0
Zakarpatska Oblast
Country [149] 0 0
Ukraine
State/province [149] 0 0
Kyiv

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
Gynecologic Oncology Group
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/NCT03740165