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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03740165




Registration number
NCT03740165
Ethics application status
Date submitted
12/11/2018
Date registered
14/11/2018
Date last updated
2/07/2020

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)
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)
Secondary ID [1] 0 0
2018-001973-25
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
Other interventions - Pembrolizumab
Treatment: Drugs - Placebo for pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Olaparib
Treatment: Drugs - Placebo for olaparib
Other interventions - Bevacizumab

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 may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle.

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 may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle.

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 may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle.


Other interventions: 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

Other interventions: Bevacizumab
IV infusion

Intervention code [1] 0 0
Other interventions
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 - 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 presented.
Timepoint [1] 0 0
Up to approximately 6 years
Primary outcome [2] 0 0
Overall Survival (OS) - OS is defined as the time from the date of randomization to death due to any cause. The OS will be presented.
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [1] 0 0
PFS Per RECIST 1.1 As Assessed by Blinded Independent Central Review - 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 presented.
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
PFS After Next-line Treatment (PFS2) Following Discontinuation of Study Treatment As Assessed by the Investigator - PFS2 is defined as the time from randomization until PD on next-line treatment or death due to any cause, whichever occurs first. The PFS2 per Investigator assessment will be presented.
Timepoint [2] 0 0
Up to approximately 78 months
Secondary outcome [3] 0 0
Number of Participants Who Experience an Adverse Event (AE) - 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 presented.
Timepoint [3] 0 0
Up to approximately 73 months
Secondary outcome [4] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE - The number of participants who discontinue study treatment due to an AE will be presented.
Timepoint [4] 0 0
Up to approximately 6 years
Secondary outcome [5] 0 0
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) - 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 change from baseline in GHS/QoL score of participants will be presented.
Timepoint [5] 0 0
Baseline and End of Study Participation (Up to approximately 6 years)
Secondary outcome [6] 0 0
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 - 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 change from baseline in abdominal/GI symptom score of participants will be presented.
Timepoint [6] 0 0
Baseline and End of Study Participation (Up to approximately 6 years)
Secondary outcome [7] 0 0
Time to First Subsequent Anti-cancer Treatment (TFST) - 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 presented.
Timepoint [7] 0 0
Up to approximately 6 years
Secondary outcome [8] 0 0
Time to Second Subsequent Anti-cancer Treatment (TSST) - 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 presented.
Timepoint [8] 0 0
Up to approximately 6 years
Secondary outcome [9] 0 0
Time to Discontinuation of Study Treatment or Death (TDT) - 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 presented.
Timepoint [9] 0 0
Up to approximately 6 years
Secondary outcome [10] 0 0
Pathological Complete Response (pCR) Rate - 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 presented.
Timepoint [10] 0 0
Up to approximately 30 months
Secondary outcome [11] 0 0
Time Without Symptom of Disease Progression or Toxicity of Treatment (TWiST) - TWiST is defined as the time from randomization to disease progression or treatment-related toxicity, whichever occurs first. The TWiST will be presented.
Timepoint [11] 0 0
Up to approximately 6 years

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,
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 or 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 7 days prior to randomization

- Is not pregnant, not breastfeeding, and 1 of the following conditions applies: a.) Not
a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow
contraceptive guidance during the treatment period and for at least 120 days following
the last dose of pembrolizumab (or pembrolizumab placebo) and olaparib (or olaparib
placebo) and at least 210 days following the last dose of chemotherapy or bevacizumab
(if administered)

- Has adequate organ function
Minimum age
18 Years
Maximum age
No limit
Gender
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 (CNS) metastases and/or carcinomatous
meningitis

- 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 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 virus (HBV) or known active hepatitis C virus (HCV)
infection

- 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, defined as defined as systolic >140 mm Hg or diastolic
>90 mm Hg documented by 2 blood pressure readings taken at least 1 hour apart. Note:
This applies to participants who will receive bevacizumab. Use of antihypertensive
medications to control blood pressure is allowed.

- 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 randomization,
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 olaparib (or olaparib
placebo) and at least 210 days following the last dose of chemotherapy or bevacizumab
(if administered)

- Has received prior treatment for advanced or metastatic 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

- 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, enzalutamide, 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

- Has received whole blood transfusions in the last 120 days prior to randomization

- Is currently participating or has participated in a study of an investigational agent
or has used an investigational device within 4 weeks of the first dose of study
treatment

- 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 2 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
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Rhode Island
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United States of America
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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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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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Limburg
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Belgium
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Luxembourg
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams-Brabant
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Belgium
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Liege
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Brazil
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Ceara
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Brazil
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Goias
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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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Canada
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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 Metropolitana De Santiago
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Chile
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Valparaiso
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Chile
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Antofagasta
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Colombia
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Atlantico
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Colombia
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Cesar
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Colombia
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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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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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Praha, Hlavni Mesto
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Czechia
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Olomouc
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France
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Auvergne
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France
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Finistere
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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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Meurthe-et-Moselle
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France
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Val-de-Marne
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France
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Paris
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Germany
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Nordrhein-Westfalen
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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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HaDarom
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Israel
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HaMerkaz
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Israel
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Heifa
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Israel
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Tell Abib
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Israel
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Yerushalayim
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Italy
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Bari
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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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Padova
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Italy
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Roma
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Italy
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Torino
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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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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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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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Pomorskie
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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
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Russian Federation
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Arkhangelskaya 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
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Sankt-Peterburg
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Russian Federation
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Tatarstan, Respublika
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South Africa
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Eastern Cape
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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A Coruna [La Coruna]
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Spain
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Barcelona [Barcelona]
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Spain
State/province [108] 0 0
Gipuzkoa
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Spain
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Lugo [Lugo]
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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
State/province [112] 0 0
Madrid
Country [113] 0 0
Spain
State/province [113] 0 0
Sevilla
Country [114] 0 0
Taiwan
State/province [114] 0 0
Changhua
Country [115] 0 0
Taiwan
State/province [115] 0 0
Taichung
Country [116] 0 0
Taiwan
State/province [116] 0 0
Tainan
Country [117] 0 0
Taiwan
State/province [117] 0 0
Taipei
Country [118] 0 0
Taiwan
State/province [118] 0 0
Taoyuan
Country [119] 0 0
Turkey
State/province [119] 0 0
Adana
Country [120] 0 0
Turkey
State/province [120] 0 0
Istanbul
Country [121] 0 0
Turkey
State/province [121] 0 0
Ankara
Country [122] 0 0
Turkey
State/province [122] 0 0
Antalya
Country [123] 0 0
Turkey
State/province [123] 0 0
Bursa
Country [124] 0 0
Turkey
State/province [124] 0 0
Sakarya
Country [125] 0 0
Ukraine
State/province [125] 0 0
Ivano-Frankivska Oblast
Country [126] 0 0
Ukraine
State/province [126] 0 0
Kharkivska Oblast
Country [127] 0 0
Ukraine
State/province [127] 0 0
Khmelnytska Oblast
Country [128] 0 0
Ukraine
State/province [128] 0 0
Kyivska Oblast
Country [129] 0 0
Ukraine
State/province [129] 0 0
Lvivska Oblast
Country [130] 0 0
Ukraine
State/province [130] 0 0
Odeska Oblast
Country [131] 0 0
Ukraine
State/province [131] 0 0
Sumska Oblast
Country [132] 0 0
Ukraine
State/province [132] 0 0
Zakarpatska Oblast

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to 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) and/or Overall Survival
(OS), 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 and/or OS.
Trial website
https://clinicaltrials.gov/show/NCT03740165
Trial related presentations / publications
Public notes

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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03740165