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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740165
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
European Network for Gynaecological Oncological Trial Groups
Gynecologic Oncology Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms Biological: Pembrolizumab Drug: Placebo for pembrolizumab Drug: Carboplatin Drug: Paclitaxel Drug: Olaparib Drug: Placebo for olaparib Biological: Bevacizumab Phase 3

Detailed Description:

Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel, participants will be randomly assigned in to one of three treatment arms:

  • Pembrolizumab+Olaparib,
  • Pembrolizumab+Placebo for Olaparib, or
  • Placebo for Pembrolizumab+Placebo for Olaparib.

At Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:

  1. up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle
  2. up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or
  3. up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1086 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : August 8, 2025
Estimated Study Completion Date : August 8, 2025


Arm Intervention/treatment
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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Carboplatin
IV infusion
Other Name: PARAPLATIN®

Drug: Paclitaxel
IV infusion
Other Name: TAXOL®

Drug: Olaparib
Oral tablet
Other Names:
  • MK-7339
  • LYNPARZA®

Biological: Bevacizumab
IV infusion
Other Name: AVASTIN®

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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Carboplatin
IV infusion
Other Name: PARAPLATIN®

Drug: Paclitaxel
IV infusion
Other Name: TAXOL®

Drug: Placebo for olaparib
Oral tablet

Biological: Bevacizumab
IV infusion
Other Name: AVASTIN®

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.
Drug: Placebo for pembrolizumab
IV infusion
Other Name: normal saline or dextrose

Drug: Carboplatin
IV infusion
Other Name: PARAPLATIN®

Drug: Paclitaxel
IV infusion
Other Name: TAXOL®

Drug: Placebo for olaparib
Oral tablet

Biological: Bevacizumab
IV infusion
Other Name: AVASTIN®




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator [ Time Frame: Up to approximately 6 years ]
    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.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 6 years ]
    OS is defined as the time from the date of randomization to death due to any cause. The OS will be presented.


Secondary Outcome Measures :
  1. PFS Per RECIST 1.1 As Assessed by Blinded Independent Central Review [ Time Frame: Up to approximately 6 years ]
    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.

  2. PFS After Next-line Treatment (PFS2) Following Discontinuation of Study Treatment As Assessed by the Investigator [ Time Frame: Up to approximately 78 months ]
    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.

  3. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 73 months ]
    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.

  4. Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 6 years ]
    The number of participants who discontinue study treatment due to an AE will be presented.

  5. 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) [ Time Frame: Baseline and End of Study Participation (Up to approximately 6 years) ]
    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.

  6. 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 [ Time Frame: Baseline and End of Study Participation (Up to approximately 6 years) ]
    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.

  7. Time to First Subsequent Anti-cancer Treatment (TFST) [ Time Frame: Up to approximately 6 years ]
    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.

  8. Time to Second Subsequent Anti-cancer Treatment (TSST) [ Time Frame: Up to approximately 6 years ]
    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.

  9. Time to Discontinuation of Study Treatment or Death (TDT) [ Time Frame: Up to approximately 6 years ]
    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.

  10. Pathological Complete Response (pCR) Rate [ Time Frame: Up to approximately 30 months ]
    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.

  11. Time Without Symptom of Disease Progression or Toxicity of Treatment (TWiST) [ Time Frame: Up to approximately 6 years ]
    TWiST is defined as the time from randomization to disease progression or treatment-related toxicity, whichever occurs first. The TWiST will be presented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740165


Contacts
Layout table for location contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Hide Hide 168 study locations
Layout table for location information
United States, Florida
Sarasota Memorial Hospital ( Site 0023) Recruiting
Sarasota, Florida, United States, 34239
Contact: Study Coordinator    941-917-6519      
United States, Missouri
Washington University - School of Medicine ( Site 0062) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-362-1740      
United States, Nebraska
Nebraska Methodist Hospital ( Site 0063) Recruiting
Omaha, Nebraska, United States, 68114
Contact: Study Coordinator    402-354-8250      
United States, Ohio
Miami Valley Hospital [Dayton, OH] ( Site 0073) Recruiting
Centerville, Ohio, United States, 45459
Contact: Study Coordinator    937-438-7819      
United States, Rhode Island
Women and Infants Hospital [Providence, RI] ( Site 0039) Recruiting
Providence, Rhode Island, United States, 02905
Contact: Study Coordinator    401-453-7520      
Australia, New South Wales
St George Hospital ( Site 2207) Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Study Coordinator    +61291133461      
Australia, Queensland
Cairns and Hinterland Hospital and Health Service ( Site 2201) Recruiting
Cairns, Queensland, Australia, 4870
Contact: Study Coordinator    +61742268085      
Australia, Victoria
Monash Health ( Site 2204) Recruiting
Clayton, Victoria, Australia, 3168
Contact: Study Coordinator    +6185722024      
Sunshine Hospital. ( Site 2205) Recruiting
St Albans, Victoria, Australia, 3021
Contact: Study Coordinator    +61404450141      
Australia
Ballarat Health Services ( Site 2202) Recruiting
Ballarat, Australia, 3350
Contact: Study Coordinator    +61353204000      
Belgium
Imelda Ziekenhuis Bonheiden ( Site 0301) Recruiting
Bonheiden, Belgium, 2820
Contact: Study Coordinator    +3215504625      
Cliniques Universitaires Saint-Luc ( Site 0312) Recruiting
Brussels, Belgium, 1200
Contact: Study Coordinator    +3227645471      
Grand Hopital de Charleroi ( Site 0302) Recruiting
Charleroi, Belgium, 6000
Contact: Study Coordinator    +3271104762      
AZ Maria Middelares Gent ( Site 0300) Recruiting
Gent, Belgium, 9000
Contact: Study Coordinator    +3292469522      
Universitair Ziekenhuis Gent ( Site 0307) Recruiting
Gent, Belgium, 9000
Contact: Study Coordinator    +3293320341      
Jessa Ziekenhuis ( Site 0309) Recruiting
Hasselt, Belgium, 3500
Contact: Study Coordinator    +3211337960      
UZ Leuven Campus Gasthuisberg ( Site 0306) Recruiting
Leuven, Belgium, 3000
Contact: Study Coordinator    +3216347419      
Centre Hospitalier de l'Ardenne ( Site 0303) Recruiting
Libramont, Belgium, 6800
Contact: Study Coordinator    +3261238111      
CHU de Liege ( Site 0310) Recruiting
Liege, Belgium, 4000
Contact: Study Coordinator    +3243679519      
Brazil
Instituto do Cancer do Ceara ( Site 2707) Recruiting
Fortaleza, Ceara, Brazil, 60430-230
Contact: Study Coordinator    +558532884576      
Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700) Recruiting
Rio de Janeiro, RJ, Brazil, 20220-410
Contact: Study Coordinator    +552132076507      
Hospital de Caridade de Ijui ( Site 2712) Recruiting
Ijui, RS, Brazil, 98700-000
Contact: Study Coordinator    +555533319393      
Hospital Bruno Born ( Site 2704) Recruiting
Lajeado, RS, Brazil, 95900-000
Contact: Study Coordinator    +5551371475002476      
Hospital Nossa Senhora Da Conceicao ( Site 2703) Recruiting
Porto Alegre, RS, Brazil, 91350-200
Contact: Study Coordinator    +555133572092      
Hospital Sao Jose ( Site 2710) Recruiting
Sao Paulo, SP, Brazil, 01321-001
Contact: Study Coordinator    +551135056675      
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708) Recruiting
Goiania, Brazil, 74605-070
Contact: Study Coordinator    +556232437260      
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714) Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Study Coordinator    +551138932686      
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706) Recruiting
Sao Paulo, Brazil, 01317-000
Contact: Study Coordinator    11991931500      
Canada, Alberta
Tom Baker Cancer Centre ( Site 0200) Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Study Coordinator    4039190251      
Canada, Ontario
Kingston Health Sciences Centre ( Site 0207) Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Study Coordinator    61354966666694      
The Credit Valley Hospital ( Site 0206) Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Study Coordinator    9058134759      
Princess Margaret Hospital.. ( Site 0202) Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator    4169464501      
Canada, Quebec
CIUSSS du Saguenay-Lac-St-Jean ( Site 0218) Recruiting
Chicoutimi, Quebec, Canada, G7H 5H6
Contact: Study Coordinator    41854110002707      
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219) Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Study Coordinator    51425234005853      
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208) Recruiting
Montreal, Quebec, Canada, H2X 0A9
Contact: Study Coordinator    514890800030657      
Royal Victoria Hospital McGill University Health Centre ( Site 0211) Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Study Coordinator    514934193431975      
Chile
Oncocentro ( Site 2801) Recruiting
Vina del Mar, Valparaiso, Chile, 2520598
Contact: Study Coordinator    +56992369820      
Centro Oncologico Antofagasta ( Site 2804) Recruiting
Antofagasta, Chile, 1240000
Contact: Study Coordinator    +56994198125      
Fundacion Arturo Lopez Perez FALP ( Site 2800) Completed
Santiago, Chile, 7500921
Sociedad Oncovida S.A. ( Site 2807) Recruiting
Santiago, Chile, 7510032
Contact: Study Coordinator    +56998634501      
Iram Cancer Research ( Site 2809) Recruiting
Santiago, Chile, 7630370
Contact: Study Coordinator    +56931912746      
Pontificia Universidad Catolica de Chile ( Site 2805) Recruiting
Santiago, Chile, 8330032
Contact: Study Coordinator    +56223547919      
Consulta Privada. ( Site 2808) Recruiting
Temuco, Chile, 4810148
Contact: Study Coordinator    +56957983173      
Sociedad de Investigaciones Medicas Limitadas ( Site 2810) Recruiting
Temuco, Chile, 4810469
Contact: Study Coordinator    +56452982404      
Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 2910) Recruiting
Bogota, Cundinamarca, Colombia, 111511
Contact: Study Coordinator    +573102013510      
Hemato Oncologos S.A. ( Site 2906) Recruiting
Cali, Valle, Colombia, 760046
Contact: Study Coordinator    +573013522326      
Biomelab S A S ( Site 2900) Recruiting
Barranquilla, Colombia, 080002
Contact: Study Coordinator    +5753692451      
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912) Recruiting
Bogota, Colombia, 111321
Contact: Study Coordinator    +573176447300      
Oncomedica S.A. ( Site 2911) Recruiting
Monteria, Colombia, 230002
Contact: Study Coordinator    +573164106262      
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 2913) Recruiting
Valledupar, Colombia, 200002
Contact: Study Coordinator    +573128385292      
Czechia
Fakultni nemocnice Brno ( Site 0404) Recruiting
Brno, Czechia, 602 00
Contact: Study Coordinator    +420532233843      
Fakultni nemocnice Olomouc ( Site 0402) Recruiting
Olomouc, Czechia, 779 00
Contact: Study Coordinator    +420588444288      
Fakultni nemocnice Ostrava ( Site 0403) Recruiting
Ostrava-Poruba, Czechia, 708 52
Contact: Study Coordinator    +420597371825      
Vseobecna fakultni nemocnice v Praze ( Site 0400) Recruiting
Praha, Czechia, 120 00
Contact: Study Coordinator    +420224967451      
Nemocnice Na Bulovce ( Site 0401) Recruiting
Praha, Czechia, 180 81
Contact: Study Coordinator    +420266083202      
France
Hopital Prive Jean Mermoz ( Site 0607) Recruiting
Lyon, France, 69008
Contact: Study Coordinator    +33478782888      
Centre D Oncologie de Gentilly ( Site 0609) Recruiting
Nancy, France, 54100
Contact: Study Coordinator    +33383935005      
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610) Recruiting
Nimes, France, 30029
Contact: Study Coordinator    +33430061010      
Hopital Tenon ( Site 0612) Recruiting
Paris, France, 75020
Contact: Study Coordinator    +33156016628      
Institut de Cancerologie Lucien Neuwirth ( Site 0613) Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Study Coordinator    +334779176034      
Centre Paul Strauss ( Site 0615) Recruiting
Strasbourg, France, 67065
Contact: Study Coordinator    +33388252485      
Institut Gustave Roussy ( Site 0600) Recruiting
Villejuif, France, 94805
Contact: Study Coordinator    +3342114211      
Hungary
Orszagos Onkologiai Intezet ( Site 0800) Recruiting
Budapest, Hungary, 1122
Contact: Study Coordinator    +36309313155      
Uzsoki Utcai Korhaz ( Site 0803) Recruiting
Budapest, Hungary, 1145
Contact: Study Coordinator    +3614673776      
Debreceni Egyetem Klinikai Kozpont ( Site 0801) Recruiting
Debrecen, Hungary, 4032
Contact: Study Coordinator    +36209216022      
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802) Recruiting
Miskolc, Hungary, 3526
Contact: Study Coordinator    +36302780644      
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805) Recruiting
Pecs, Hungary, 7624
Contact: Study Coordinator    +3672536370      
Israel
Soroka Medical Center ( Site 1006) Recruiting
Beer-Sheva, Israel, 8410101
Contact: Study Coordinator    +97286244068      
Hillel Yaffe Medical Center ( Site 1011) Recruiting
Hadera, Israel, 3810101
Contact: Study Coordinator    +97246304335      
Rambam Medical Center ( Site 1002) Recruiting
Haifa, Israel, 3525408
Contact: Study Coordinator    +97247771784      
Edith Wolfson Medical Center ( Site 1003) Recruiting
Holon, Israel, 5822012
Contact: Study Coordinator    +97235028795      
Shaare Zedek Medical Center ( Site 1005) Recruiting
Jerusalem, Israel, 9103102
Contact: Study Coordinator    +97226555727      
Rabin Medical Center ( Site 1004) Recruiting
Petah Tikva, Israel, 4941492
Contact: Study Coordinator    +97239377428      
Chaim Sheba Medical Center ( Site 1000) Recruiting
Ramat Gan, Israel, 5262000
Contact: Study Coordinator    +97235303157      
Sourasky Medical Center ( Site 1001) Recruiting
Tel Aviv, Israel, 6423906
Contact: Study Coordinator    +97236973494      
Italy
A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104) Recruiting
Torino, TO, Italy, 10126
Contact: Study Coordinator    +390113134428      
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108) Recruiting
Bari, Italy, 70124
Contact: Study Coordinator    +390805555420      
Sacro Cuore di Gesu Fatebenefratelli ( Site 1112) Recruiting
Benevento, Italy, 82100
Contact: Study Coordinator    +390824771246      
Ospedale Cannizzaro ( Site 1110) Recruiting
Catania, Italy, 95126
Contact: Study Coordinator    +390957262274      
ASST Lecco. Ospedale A. Manzoni ( Site 1101) Recruiting
Lecco, Italy, 23900
Contact: Study Coordinator    +39341489155      
Istituto Europeo di Oncologia ( Site 1100) Recruiting
Milano, Italy, 20141
Contact: Study Coordinator    +390257489543      
A.O.U. Federico II di Napoli ( Site 1107) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390817464272      
Istituto Oncologico Veneto IRCCS Universita degli Studi di Padova ( Site 1113) Recruiting
Padova, Italy, 35128
Contact: Study Coordinator    +390498215931      
Policlinico Universitario Gemelli ( Site 1105) Recruiting
Roma, Italy, 00168
Contact: Study Coordinator    +390630154994      
Presidio Ospedaliero Santa Chiara ( Site 1109) Recruiting
Trento, Italy, 38122
Contact: Study Coordinator    +390461902121      
A.O. Univ. S. M. della Misericordia ( Site 1114) Recruiting
Udine, Italy, 33100
Contact: Study Coordinator    +390432559330      
Japan
National Cancer Center Hospital East ( Site 2602) Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Study Coordinator    +81471331111      
National Hospital Organization Shikoku Cancer Center ( Site 2601) Recruiting
Matsuyama, Ehime, Japan, 791-0280
Contact: Study Coordinator    +81899991111      
Ehime University Hospital ( Site 2600) Recruiting
Toon, Ehime, Japan, 791-0295
Contact: Study Coordinator    +81899645111      
Gunma Prefectural Cancer Center ( Site 2609) Recruiting
Ota, Gunma, Japan, 373-8550
Contact: Study Coordinator    +81276380771      
Hokkaido University Hospital ( Site 2607) Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact: Study Coordinator    +81117161161      
Iwate Medical University Hospital ( Site 2606) Recruiting
Shiwa-gun, Iwate, Japan, 028-3695
Contact: Study Coordinator    +81196137111      
St. Marianna University School of Medicine Hospital ( Site 2613) Recruiting
Kawasaki, Kanagawa, Japan, 216-8511
Contact: Study Coordinator    +81449778111      
University of the Ryukyus Hospital ( Site 2616) Recruiting
Nakagami-gun, Okinawa, Japan, 903-0215
Contact: Study Coordinator    +81988953331      
Saitama Medical University International Medical Center ( Site 2604) Recruiting
Hidaka, Saitama, Japan, 350-1298
Contact: Study Coordinator    +81429844111      
Saitama Cancer Center ( Site 2614) Recruiting
Kitaadachi-gun, Saitama, Japan, 362-0806
Contact: Study Coordinator    +81487221111      
National Defense Medical College Hospital ( Site 2608) Recruiting
Tokorozawa, Saitama, Japan, 359-8513
Contact: Study Coordinator    +81429951511      
Kyorin University Hospital ( Site 2610) Recruiting
Mitaka, Tokyo, Japan, 181-8611
Contact: Study Coordinator    +81422475511      
Kagoshima City Hospital ( Site 2612) Recruiting
Kagoshima, Japan, 890-8760
Contact: Study Coordinator    +81992307000      
Niigata Cancer Center Hospital ( Site 2618) Recruiting
Niigata, Japan, 951-8566
Contact: Study Coordinator    +81252665111      
Osaka International Cancer Institute ( Site 2617) Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator    +81669451181      
National Cancer Center Hospital ( Site 2605) Recruiting
Tokyo, Japan, 104-0045
Contact: Study Coordinator    +81335422511      
Korea, Republic of
Seoul National University Bundang Hospital ( Site 2404) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Study Coordinator    +82317877253      
Seoul National University Hospital ( Site 2403) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    +82220724863      
Severance Hospital Yonsei University Health System ( Site 2400) Recruiting
Seoul, Korea, Republic of, 03722
Contact: Study Coordinator    +82222282246      
Asan Medical Center ( Site 2402) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82230103640      
Samsung Medical Center ( Site 2401) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82234103513      
Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1406) Recruiting
Gliwice, Slaskie, Poland, 44-101
Contact: Study Coordinator    +48322788613      
Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410) Recruiting
Kielce, Swietokrzyskie, Poland, 25-734
Contact: Study Coordinator    +48413674357      
Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1412) Recruiting
Bialystok, Poland, 15-027
Contact: Study Coordinator    +48856656732      
Szpitale Pomorskie Sp. z o.o. ( Site 1407) Recruiting
Gdynia, Poland, 81-519
Contact: Study Coordinator    +48587260156      
Szpital Kliniczny Przemienienia Panskiego ( Site 1401) Recruiting
Poznan, Poland, 60-569
Contact: Study Coordinator    +48618549014      
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1404) Recruiting
Warszawa, Poland, 02-781
Contact: Study Coordinator    +48225462295      
Russian Federation
Arkhangelsk Clinical Oncological Dispensary ( Site 1508) Recruiting
Arkhangelsk, Russian Federation, 163045
Contact: Study Coordinator    +78182275913      
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509) Recruiting
Kazan, Russian Federation, 420029
Contact: Study Coordinator    +79172662851      
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500) Recruiting
Moscow, Russian Federation, 115478
Contact: Study Coordinator    +79036787205      
FSCC of Special Types of Med. Care and Technologies ( Site 1503) Recruiting
Moscow, Russian Federation, 115682
Contact: Study Coordinator    +74953956197      
Medical Rehabilitation Center ( Site 1502) Recruiting
Moscow, Russian Federation, 125367
Contact: Study Coordinator    +79264375889      
A. Tsyb Medical Radiological Research Center ( Site 1513) Recruiting
Obninsk, Russian Federation, 249036
Contact: Study Coordinator    +79107070109      
City Clinical Oncology Center ( Site 1505) Recruiting
Saint Petersburg, Russian Federation, 198255
Contact: Study Coordinator    +78129351330      
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504) Recruiting
St. Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219464788      
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507) Recruiting
Ufa, Russian Federation, 450054
Contact: Study Coordinator    +73472485518      
South Africa
Cancer Care Langenhoven Drive Oncology Centre ( Site 1701) Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6045
Contact: Study Coordinator    +27414506154      
Wits Clinical Research ( Site 1702) Recruiting
Parktown-Johannesburg, Gauteng, South Africa, 2193
Contact: Study Coordinator    +27113390620      
Curo Oncology ( Site 1710) Recruiting
Pretoria, Gauteng, South Africa, 0031
Contact: Study Coordinator    +27123356771      
Wilgers Oncology Centre ( Site 1705) Recruiting
Pretoria, Gauteng, South Africa, 0081
Contact: Study Coordinator    +27128072744      
Little Company of Mary Hospital ( Site 1700) Recruiting
Pretoria, Gauteng, South Africa, 0181
Contact: Study Coordinator    +27123466701      
Cancercare ( Site 1706) Recruiting
Cape Town, Western Cape, South Africa, 7700
Contact: Study Coordinator    +27219443700      
Outeniqua Cancercare Oncology Unit ( Site 1708) Recruiting
George, Western Cape, South Africa, 6530
Contact: Study Coordinator    +27413630581      
Cape Town Oncology Trials Pty Ltd ( Site 1707) Recruiting
Kraaifontein, Western Cape, South Africa, 7570
Contact: Study Coordinator    +27219443830      
The Oncology Centre ( Site 1709) Recruiting
Durban, South Africa, 4001
Contact: Study Coordinator    +27312088666      
Sandton Oncology Medical Group PTY LTD ( Site 1712) Recruiting
Johannesburg, South Africa, 2196
Contact: Study Coordinator    +27118830900      
Department of Medical Oncology ( Site 1703) Recruiting
Pretoria, South Africa, 0002
Contact: Study Coordinator    +27123541054      
Spain
Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608) Recruiting
A Coruna, Spain, 15006
Contact: Study Coordinator    +34981178000      
Hospital Provincial San Pedro de Alcantara ( Site 1607) Recruiting
Caceres, Spain, 10003
Contact: Study Coordinator    +34927621612      
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603) Recruiting
Hospitalet de Llobregat, Spain, 08909
Contact: Study Coordinator    +34932607333      
Hospital Universitario Lucus Augusti ( Site 1609) Recruiting
Lugo, Spain, 27003
Contact: Study Coordinator    +34982295112      
Clinica Universitaria de Navarra ( Site 1600) Recruiting
Madrid, Spain, 28027
Contact: Study Coordinator    +349135319207513      
Xarxa Assistencial Universitaria Manresa ( Site 1605) Recruiting
Manresa, Spain, 08243
Contact: Study Coordinator    +349387593005512      
Hospital Universitario de Donostia ( Site 1602) Recruiting
San Sebastian, Spain, 20014
Contact: Study Coordinator    +34943006032      
Hospital Universitario Virgen del Rocio ( Site 1604) Recruiting
Sevilla, Spain, 41013
Contact: Study Coordinator    +34955013068      
Hospital de Terrassa ( Site 1606) Recruiting
Terrassa, Spain, 08227
Contact: Study Coordinator    +34937003612      
Instituto Valenciano de Oncologia ( Site 1601) Recruiting
Valencia, Spain, 46009
Contact: Study Coordinator    +34961114013      
Hospital General Universitario de Valencia ( Site 1610) Recruiting
Valencia, Spain, 46014
Contact: Study Coordinator    +34963187527      
Taiwan
Changhua Christian Hospital ( Site 2507) Recruiting
Changhua, Taiwan, 500
Contact: Study Coordinator    +886917154085      
China Medical University Hospital ( Site 2506) Recruiting
Taichung, Taiwan, 40447
Contact: Study Coordinator    +886422052121      
Taichung Veterans General Hospital ( Site 2510) Recruiting
Taichung, Taiwan, 40705
Contact: Study Coordinator    +886423592525      
National Cheng Kung University Hospital ( Site 2508) Recruiting
Tainan, Taiwan, 704
Contact: Study Coordinator    +88662353535      
National Taiwan University Hospital ( Site 2502) Recruiting
Taipei, Taiwan, 10002
Contact: Study Coordinator    +886972651480      
MacKay Memorial Hospital ( Site 2500) Recruiting
Taipei, Taiwan, 104
Contact: Study Coordinator    +886975835334      
Taipei Veterans General Hospital ( Site 2503) Recruiting
Taipei, Taiwan, 11217
Contact: Study Coordinator    +886912039453      
Linkou Chang Gung Memorial Hospital ( Site 2501) Recruiting
Taoyuan, Taiwan, 33305
Contact: Study Coordinator    886975365883      
Turkey
Etlik Zubeyde Hanım Gynecology Research Hospital ( Site 1903) Recruiting
Ankara, Turkey, 06010
Contact: Study Coordinator    +905327933357      
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905) Recruiting
Ankara, Turkey, 06590
Contact: Study Coordinator    +905323633030      
Akdeniz Universitesi Tıp Fakultesi ( Site 1901) Recruiting
Antalya, Turkey, 07070
Contact: Study Coordinator    +905424327513      
Uludag Universitesi Tip Fakultesi ( Site 1904) Recruiting
Bursa, Turkey, 16059
Contact: Study Coordinator    +905323739469      
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900) Recruiting
Istanbul, Turkey, 34093
Contact: Study Coordinator    +905325637597      
Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907) Recruiting
Istanbul, Turkey, 34147
Contact: Study Coordinator    +905052703550      
Istanbul Acibadem University Atakent Hospital ( Site 1902) Recruiting
Kucukcekmece, Turkey, 34303
Contact: Study Coordinator    +905323135566      
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906) Recruiting
Sakarya, Turkey, 54290
Contact: Study Coordinator    +905322168074      
Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2181) Recruiting
Ivano-Frankivsk, Ukraine, 76018
Contact: Study Coordinator    +380342502269      
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180) Recruiting
Kharkiv, Ukraine, 61024
Contact: Study Coordinator    +380956622833      
Khmelnytskyi Regional Hospital ( Site 2190) Recruiting
Khmelnitskiy, Ukraine, 29000
Contact: Study Coordinator    +380979242755      
Kyiv City Clinical Oncological Center ( Site 2140) Recruiting
Kyiv, Ukraine, 03115
Contact: Study Coordinator    +380503818536      
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170) Recruiting
Lviv, Ukraine, 79031
Contact: Study Coordinator    +380677479407      
MI Odessa Regional Oncological Centre ( Site 2121) Recruiting
Odesa, Ukraine, 65055
Contact: Study Coordinator    +380487202605      
RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191) Recruiting
Sumy, Ukraine, 40022
Contact: Study Coordinator    +380509158586      
Central City Clinical Hospital ( Site 2150) Recruiting
Uzhgorod, Ukraine, 88000
Contact: Study Coordinator    +380505048997      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
European Network for Gynaecological Oncological Trial Groups
Gynecologic Oncology Group
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03740165    
Other Study ID Numbers: 7339-001
2018-001973-25 ( EudraCT Number )
ENGOT-ov43 ( Other Identifier: European Network for Gynaecological Oncological Trial Groups )
MK-7339-001 ( Other Identifier: Merck )
KEYLYNK-001 ( Other Identifier: Merck )
194619 ( Registry Identifier: Japic-CTI )
GOG-3036 ( Other Identifier: Gynecologic Oncology Group )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Pembrolizumab
Olaparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents