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)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03740165
• Collaborator: European Network of Gynaecological Oncological Trial Groups (ENGOT) (Other), Gynecologic Oncology Group (Other)
• Enrollment: 1,284
• Locations: 227
• Arms: 3
• Anticipated Duration (Months): 77.4
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.

The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.

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; Drug: Docetaxel	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

• 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.

Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1284 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 / GOG-3036)
• Actual Study Start Date: Dec 18, 2018
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: May 30, 2025

Arms and Interventions

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 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.	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475 KEYTRUDA® ; Drug: Carboplatin; IV infusion; Other Names: PARAPLATIN® ; Drug: Paclitaxel; IV infusion; Other Names: TAXOL® ; Drug: Olaparib; Oral tablet; Other Names: MK-7339 LYNPARZA® ; Biological: Bevacizumab; IV infusion; Other Names: AVASTIN® ; Drug: Docetaxel; IV infusion
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.	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475 KEYTRUDA® ; Drug: Carboplatin; IV infusion; Other Names: PARAPLATIN® ; Drug: Paclitaxel; IV infusion; Other Names: TAXOL® ; Drug: Placebo for olaparib; Oral tablet; Biological: Bevacizumab; IV infusion; Other Names: AVASTIN® ; Drug: Docetaxel; IV infusion
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.	Drug: Placebo for pembrolizumab; IV infusion; Other Names: normal saline or dextrose ; Drug: Carboplatin; IV infusion; Other Names: PARAPLATIN® ; Drug: Paclitaxel; IV infusion; Other Names: TAXOL® ; Drug: Placebo for olaparib; Oral tablet; Biological: Bevacizumab; IV infusion; Other Names: AVASTIN® ; Drug: Docetaxel; IV infusion

Outcome Measures

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 in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]≥10) Tumors [Up to approximately 57 months]

   PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1-positive (CPS≥10) tumors.

2. PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants [Up to approximately 57 months]

   PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants.

Secondary Outcome Measures

1. Overall Survival (OS) in All Participants [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 reported for all participants.

2. PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants with PD-L1-Positive Tumors (CPS≥10) Tumors [Up to approximately 57 months]

   PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for participants with PD-L1-positive (CPS≥10) tumors.

3. PFS Per RECIST 1.1 as Assessed by BICR in All Participants [Up to approximately 57 months]

   PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for all participants.

4. PFS After Next-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants with PD-L1-Positive Tumors (CPS≥10) Tumors [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 reported for participants with PD-L1-positive (CPS≥10) tumors.

5. PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants [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 reported for all participants.

6. Number of Participants Who Experience an Adverse Event (AE) [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 reported.

7. Number of Participants Who Discontinue Study Treatment Due to an AE [Up to approximately 6 years]

   An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

8. 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) [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 reported.

9. 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 [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 reported.

10. Time to First Subsequent Anti-cancer Treatment (TFST) [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 reported.

11. Time to Second Subsequent Anti-cancer Treatment (TSST) [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 reported.

12. Time to Discontinuation of Study Treatment or Death (TDT) [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 reported.

13. Pathological Complete Response (pCR) Rate [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 reported.

14. Time Without Symptom of Disease Progression or Toxicity of Treatment (TWiST) [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 reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

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

• 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 (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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham (UAB) ( Site 0036)	Birmingham	Alabama	United States	35233
2	University of Arizona Cancer Center ( Site 0074)	Tucson	Arizona	United States	85719
3	Disney Family Cancer Center ( Site 0042)	Burbank	California	United States	91505
4	Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)	Oakland	California	United States	94611
5	Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)	Roseville	California	United States	95661
6	Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)	Sacramento	California	United States	95814
7	Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)	San Francisco	California	United States	94115
8	Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)	Santa Clara	California	United States	95051
9	Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)	Vallejo	California	United States	94589
10	Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)	Walnut Creek	California	United States	94596
11	Smilow Cancer Center at Yale-New Haven ( Site 0057)	New Haven	Connecticut	United States	06511
12	Sarasota Memorial Hospital ( Site 0023)	Sarasota	Florida	United States	34239
13	Emory School of Medicine ( Site 0053)	Atlanta	Georgia	United States	30322
14	Northeast Georgia Medical Center ( Site 0029)	Gainesville	Georgia	United States	30501
15	Memorial Health University Medical Center ( Site 0011)	Savannah	Georgia	United States	31404
16	Rush University Medical Center ( Site 0019)	Chicago	Illinois	United States	60612
17	University of Chicago ( Site 0049)	Chicago	Illinois	United States	60637
18	Dr. Sudarshan K. Sharma, LTD ( Site 0061)	Hinsdale	Illinois	United States	60521
19	Saint Vincent Hospital and Health Center ( Site 0012)	Indianapolis	Indiana	United States	46260
20	University of Iowa Hospital and Clinics ( Site 0005)	Iowa City	Iowa	United States	52242
21	University of Kentucky ( Site 0045)	Lexington	Kentucky	United States	40536
22	Weinberg Cancer Institute at Franklin Square ( Site 0035)	Baltimore	Maryland	United States	21237
23	Saint Dominic - Jackson Memorial Hospital ( Site 0072)	Jackson	Mississippi	United States	39216
24	Washington University - School of Medicine ( Site 0062)	Saint Louis	Missouri	United States	63110
25	Nebraska Methodist Hospital ( Site 0063)	Omaha	Nebraska	United States	68114
26	Dartmouth Hitchcock Medical Center ( Site 0024)	Lebanon	New Hampshire	United States	03756
27	MD Anderson Cancer Center at Cooper ( Site 0067)	Camden	New Jersey	United States	08103
28	Holy Name Medical Center ( Site 0037)	Teaneck	New Jersey	United States	07666
29	Northwell Health- Monter Cancer Center ( Site 0075)	Lake Success	New York	United States	11042
30	Sanford Roger Maris Cancer Center ( Site 0082)	Fargo	North Dakota	United States	58122
31	Miami Valley Hospital [Dayton, OH] ( Site 0073)	Centerville	Ohio	United States	45459
32	Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)	Cincinnati	Ohio	United States	45242
33	The Bing Cancer Center ( Site 0044)	Columbus	Ohio	United States	43214
34	OSU Wexner Medical Center ( Site 0076)	Hilliard	Ohio	United States	43026
35	Women and Infants Hospital [Providence, RI] ( Site 0039)	Providence	Rhode Island	United States	02905
36	Sanford Gynecology Oncology ( Site 0004)	Sioux Falls	South Dakota	United States	57104
37	Texas Oncology, P.A. - Bedford ( Site 8005)	Bedford	Texas	United States	76022
38	Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)	Dallas	Texas	United States	75231
39	Parkland Hospital ( Site 0081)	Dallas	Texas	United States	75235
40	UT Southwestern Medical Center ( Site 0046)	Dallas	Texas	United States	75390
41	Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)	Tyler	Texas	United States	75702
42	Virginia Cancer Specialists, PC ( Site 8003)	Gainesville	Virginia	United States	20155
43	MEDICAL COLLEGE OF WISCONSIN ( Site 0064)	Milwaukee	Wisconsin	United States	53226
44	St George Hospital ( Site 2207)	Kogarah	New South Wales	Australia	2217
45	Cairns and Hinterland Hospital and Health Service ( Site 2201)	Cairns	Queensland	Australia	4870
46	Ballarat Health Services ( Site 2202)	Ballarat	Victoria	Australia	3350
47	Monash Health ( Site 2204)	Clayton	Victoria	Australia	3168
48	Sunshine Hospital. ( Site 2205)	St Albans	Victoria	Australia	3021
49	Imelda Ziekenhuis Bonheiden ( Site 0301)	Bonheiden	Antwerpen	Belgium	1932
50	UZ Leuven Campus Gasthuisberg ( Site 0306)	Leuven	Antwerpen	Belgium	3000
51	Cliniques Universitaires Saint-Luc ( Site 0312)	Brussels	Bruxelles-Capitale, Region De	Belgium	1200
52	Grand Hopital de Charleroi ( Site 0302)	Charleroi	Hainaut	Belgium	6000
53	CHU de Liege ( Site 0310)	Liège	Liege	Belgium	4000
54	Jessa Ziekenhuis ( Site 0309)	Hasselt	Limburg	Belgium	3500
55	Centre Hospitalier de l'Ardenne ( Site 0303)	Libramont	Luxembourg	Belgium	6800
56	AZ Maria Middelares Gent ( Site 0300)	Gent	Oost-Vlaanderen	Belgium	9000
57	UZ Gent ( Site 0307)	Gent	Oost-Vlaanderen	Belgium	9000
58	Instituto do Cancer do Ceara ( Site 2707)	Fortaleza	Ceara	Brazil	60430-230
59	Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)	Goiania	Goias	Brazil	74605-070
60	Hospital Erasto Gaertner ( Site 2716)	Curitiba	Parana	Brazil	82520-060
61	Hospital de Caridade de Ijui ( Site 2712)	Ijui	Rio Grande Do Sul	Brazil	98700-000
62	Hospital Bruno Born ( Site 2704)	Lajeado	Rio Grande Do Sul	Brazil	95900-000
63	Hospital Nossa Senhora Da Conceicao ( Site 2703)	Porto Alegre	Rio Grande Do Sul	Brazil	91350-200
64	Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)	Rio de Janeiro		Brazil	20220-410
65	Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)	Sao Paulo		Brazil	01246-000
66	Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)	Sao Paulo		Brazil	01317-000
67	Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)	Sao Paulo		Brazil	01321-001
68	Tom Baker Cancer Centre ( Site 0200)	Calgary	Alberta	Canada	T2N 4N2
69	Kingston Health Sciences Centre ( Site 0207)	Kingston	Ontario	Canada	K7L 2V7
70	The Credit Valley Hospital ( Site 0206)	Mississauga	Ontario	Canada	L5M 2N1
71	Princess Margaret Hospital.. ( Site 0202)	Toronto	Ontario	Canada	M5G 2M9
72	CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)	Chicoutimi	Quebec	Canada	G7H 5H6
73	CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)	Montreal	Quebec	Canada	H1T 2M4
74	Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)	Montreal	Quebec	Canada	H2X 0A9
75	Royal Victoria Hospital McGill University Health Centre ( Site 0211)	Montreal	Quebec	Canada	H4A 3J1
76	Centro Investigación del Cáncer James Lind ( Site 2810)	Temuco	Araucania	Chile	4780000
77	Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)	Temuco	Araucania	Chile	4810218
78	Fundacion Arturo Lopez Perez FALP ( Site 2800)	Santiago	Region M. De Santiago	Chile	7500922
79	Sociedad Oncovida S.A. ( Site 2807)	Santiago	Region M. De Santiago	Chile	7510032
80	Iram Cancer Research ( Site 2809)	Santiago	Region M. De Santiago	Chile	7630370
81	Pontificia Universidad Catolica de Chile ( Site 2805)	Santiago	Region M. De Santiago	Chile	8330032
82	Oncocentro ( Site 2801)	Vina del Mar	Valparaiso	Chile	2520598
83	Centro Oncologico Antofagasta ( Site 2804)	Antofagasta		Chile	1240000
84	Biomelab S A S ( Site 2900)	Barranquilla	Atlantico	Colombia	080002
85	Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)	Valledupar	Cesar	Colombia	200001
86	Oncomedica S.A. ( Site 2911)	Monteria	Cordoba	Colombia	230002
87	Instituto Nacional de Cancerologia E.S.E ( Site 2910)	Bogota	Distrito Capital De Bogota	Colombia	110321
88	Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)	Bogota	Distrito Capital De Bogota	Colombia	111321
89	Centro Medico Imbanaco de Cali S.A ( Site 2909)	Cali	Valle Del Cauca	Colombia	760042
90	Hemato Oncologos S.A. ( Site 2906)	Cali	Valle Del Cauca	Colombia	760042
91	Fakultni nemocnice Brno ( Site 0404)	Brno	Brno-mesto	Czechia	602 00
92	Fakultni nemocnice Ostrava ( Site 0403)	Ostrava-Poruba	Moravskoslezsky Kraj	Czechia	708 52
93	Vseobecna fakultni nemocnice v Praze ( Site 0400)	Praha	Praha, Hlavni Mesto	Czechia	120 00
94	Nemocnice Na Bulovce ( Site 0401)	Praha	Praha, Hlavni Mesto	Czechia	180 81
95	Fakultni nemocnice Olomouc ( Site 0402)	Olomouc		Czechia	779 00
96	Hopital Prive Jean Mermoz ( Site 0607)	Lyon	Auvergne	France	69008
97	Centre Paul Strauss ( Site 0615)	Strasbourg	Bas-Rhin	France	67065
98	Hopital de la Timone ( Site 0617)	Marseille	Bouches-du-Rhone	France	13005
99	CHU de Brest -Site Hopital Morvan ( Site 0616)	Brest	Bretagne	France	29200
100	Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)	Nimes	Gard	France	30029
101	Institut de Cancerologie Lucien Neuwirth ( Site 0613)	Saint-Priest-en-Jarez	Loire	France	42270
102	Centre D Oncologie de Gentilly ( Site 0609)	Nancy	Meurthe-et-Moselle	France	54100
103	Institut Gustave Roussy ( Site 0600)	Villejuif	Val-de-Marne	France	94800
104	Hopital Tenon ( Site 0612)	Paris		France	75020
105	Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)	Stuttgart	Baden-Wurttemberg	Germany	70199
106	Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)	Muenchen	Bayern	Germany	72074
107	Uniklinik RWTH Aachen ( Site 0718)	Aachen	Nordrhein-Westfalen	Germany	52074
108	Gynaekologisches Zentrum ( Site 0712)	Bonn	Nordrhein-Westfalen	Germany	53111
109	Klinikum Dortmund gGmbH ( Site 0717)	Dortmund	Nordrhein-Westfalen	Germany	44137
110	Universitaetsklinikum Duesseldorf ( Site 0704)	Duesseldorf	Nordrhein-Westfalen	Germany	40225
111	HELIOS Klinikum Krefeld ( Site 0715)	Krefeld	Nordrhein-Westfalen	Germany	47805
112	Universitaetsklinikum Muenster ( Site 0720)	Muenster	Nordrhein-Westfalen	Germany	48149
113	Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)	Saarbruecken	Saarland	Germany	66113
114	Klinikum Chemnitz gGmbH ( Site 0711)	Chemnitz	Sachsen	Germany	09116
115	Staedtisches Krankenhaus Kiel GmbH ( Site 0709)	Kiel	Schleswig-Holstein	Germany	24116
116	Charite Campus Virchow-Klinikum - CVK ( Site 0700)	Berlin		Germany	13353
117	Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)	Pecs	Baranya	Hungary	7624
118	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)	Miskolc	Borsod-Abauj-Zemplen	Hungary	1051
119	Orszagos Onkologiai Intezet ( Site 0800)	Budapest		Hungary	1122
120	Uzsoki Utcai Korhaz ( Site 0803)	Budapest		Hungary	1145
121	Debreceni Egyetem Klinikai Kozpont ( Site 0801)	Debrecen		Hungary	4032
122	Soroka Medical Center ( Site 1006)	Beer-Sheva		Israel	8410101
123	Hillel Yaffe Medical Center ( Site 1011)	Hadera		Israel	3810101
124	Carmel Medical Center ( Site 1007)	Haifa		Israel	3436212
125	Rambam Medical Center ( Site 1002)	Haifa		Israel	3525408
126	Edith Wolfson Medical Center ( Site 1003)	Holon		Israel	5822012
127	Shaare Zedek Medical Center ( Site 1005)	Jerusalem		Israel	9103102
128	Rabin Medical Center ( Site 1004)	Petah Tikva		Israel	4941492
129	Chaim Sheba Medical Center ( Site 1000)	Ramat Gan		Israel	5262000
130	Sourasky Medical Center ( Site 1001)	Tel Aviv		Israel	6423906
131	IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)	Bari	Abruzzo	Italy	70124
132	Istituto Europeo di Oncologia ( Site 1100)	Milano	Lombardia	Italy	20141
133	A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)	Torino	Piemonte	Italy	10126
134	Istituto Oncologico Veneto IRCCS ( Site 1113)	Padova	Veneto	Italy	35128
135	Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)	Benevento		Italy	82100
136	Ospedale Cannizzaro ( Site 1110)	Catania		Italy	95126
137	ASST Lecco. Ospedale A. Manzoni ( Site 1101)	Lecco		Italy	23900
138	Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)	Milano		Italy	20133
139	A.O.U. Federico II di Napoli ( Site 1107)	Napoli		Italy	80131
140	Azienda Ospedaliera Policlinico Umberto I ( Site 1111)	Roma		Italy	00161
141	Policlinico Universitario Gemelli ( Site 1105)	Roma		Italy	00168
142	Presidio Ospedaliero Santa Chiara ( Site 1109)	Trento		Italy	38122
143	A.O. Univ. S. M. della Misericordia ( Site 1114)	Udine		Italy	33100
144	National Cancer Center Hospital East ( Site 2602)	Kashiwa	Chiba	Japan	277-8577
145	National Hospital Organization Shikoku Cancer Center ( Site 2601)	Matsuyama	Ehime	Japan	791-0280
146	Ehime University Hospital ( Site 2600)	Toon	Ehime	Japan	791-0295
147	Gunma Prefectural Cancer Center ( Site 2609)	Ota	Gunma	Japan	373-8550
148	Hokkaido University Hospital ( Site 2607)	Sapporo	Hokkaido	Japan	060-8648
149	Iwate Medical University Hospital ( Site 2606)	Shiwa-gun	Iwate	Japan	028-3695
150	St. Marianna University School of Medicine Hospital ( Site 2613)	Kawasaki	Kanagawa	Japan	216-8511
151	University of the Ryukyus Hospital ( Site 2616)	Nakagami-gun	Okinawa	Japan	903-0215
152	Saitama Medical University International Medical Center ( Site 2604)	Hidaka	Saitama	Japan	350-1298
153	Saitama Cancer Center ( Site 2614)	Kitaadachi-gun	Saitama	Japan	362-0806
154	National Defense Medical College Hospital ( Site 2608)	Tokorozawa	Saitama	Japan	359-8513
155	Kyorin University Hospital ( Site 2610)	Mitaka	Tokyo	Japan	181-8611
156	Kagoshima City Hospital ( Site 2612)	Kagoshima		Japan	890-8760
157	Niigata Cancer Center Hospital ( Site 2618)	Niigata		Japan	951-8566
158	Osaka International Cancer Institute ( Site 2617)	Osaka		Japan	541-8567
159	National Cancer Center Hospital ( Site 2605)	Tokyo		Japan	104-0045
160	Seoul National University Bundang Hospital ( Site 2404)	Seongnam-si	Kyonggi-do	Korea, Republic of	13620
161	Seoul National University Hospital ( Site 2403)	Seoul		Korea, Republic of	03080
162	Severance Hospital Yonsei University Health System ( Site 2400)	Seoul		Korea, Republic of	03722
163	Asan Medical Center ( Site 2402)	Seoul		Korea, Republic of	05505
164	Samsung Medical Center ( Site 2401)	Seoul		Korea, Republic of	06351
165	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (	Warszawa	Mazowieckie	Poland	02-781
166	Bialostockie Centrum Onkologii ( Site 1412)	Bialystok	Podlaskie	Poland	15-027
167	Szpitale Pomorskie Sp. z o.o. ( Site 1407)	Gdynia	Pomorskie	Poland	81-519
168	Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)	Gliwice	Slaskie	Poland	44-102
169	Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)	Kielce	Swietokrzyskie	Poland	25-734
170	Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna	Poznan	Wielkopolskie	Poland	61-848
171	Arkhangelsk Clinical Oncological Dispensary ( Site 1508)	Arkhangelsk	Arkhangel Skaya Oblast	Russian Federation	163045
172	Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)	Ufa	Baskortostan, Respublika	Russian Federation	450054
173	A. Tsyb Medical Radiological Research Center ( Site 1513)	Obninsk	Kaluzskaja Oblast	Russian Federation	249036
174	FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)	Moscow	Moskva	Russian Federation	115478
175	FSCC of Special Types of Med. Care and Technologies ( Site 1503)	Moscow	Moskva	Russian Federation	115682
176	Medical Rehabilitation Center ( Site 1502)	Moscow	Moskva	Russian Federation	125367
177	City Clinical Oncology Center ( Site 1505)	Saint Petersburg	Sankt-Peterburg	Russian Federation	198255
178	National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)	Saint-Petersburg	Sankt-Peterburg	Russian Federation	197758
179	Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)	Kazan	Tatarstan, Respublika	Russian Federation	420029
180	Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)	Port Elizabeth	Eastern Cape	South Africa	6045
181	Groote Schuur Hospital ( Site 1704)	Cape Town	Gauteng	South Africa	7925
182	Wits Clinical Research ( Site 1702)	Johannesburg	Gauteng	South Africa	2193
183	Department of Medical Oncology ( Site 1703)	Pretoria	Gauteng	South Africa	0002
184	Curo Oncology ( Site 1710)	Pretoria	Gauteng	South Africa	0031
185	Wilgers Oncology Centre ( Site 1705)	Pretoria	Gauteng	South Africa	0081
186	Little Company of Mary Hospital ( Site 1700)	Pretoria	Gauteng	South Africa	0181
187	Sandton Oncology Medical Group PTY LTD ( Site 1712)	Sandton	Gauteng	South Africa	2196
188	The Oncology Centre ( Site 1709)	Durban	Kwazulu-Natal	South Africa	4091
189	Cancercare ( Site 1706)	Cape Town	Western Cape	South Africa	7700
190	Outeniqua Cancercare Oncology Unit ( Site 1708)	George	Western Cape	South Africa	6530
191	Cape Town Oncology Trials Pty Ltd ( Site 1707)	Kraaifontein	Western Cape	South Africa	7570
192	Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)	Hospitalet de Llobregat	Barcelona	Spain	08909
193	Xarxa Assistencial Universitaria Manresa ( Site 1605)	Manresa	Barcelona	Spain	08243
194	Hospital de Terrassa ( Site 1606)	Terrassa	Barcelona	Spain	08227
195	Hospital Universitario de Donostia ( Site 1602)	Donostia	Gipuzkoa	Spain	20014
196	Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)	A Coruna	La Coruna	Spain	15006
197	Instituto Valenciano de Oncologia ( Site 1601)	Valencia	Valenciana, Comunitat	Spain	46009
198	Hospital General Universitario de Valencia ( Site 1610)	Valencia	Valenciana, Comunitat	Spain	46014
199	Hospital Provincial San Pedro de Alcantara ( Site 1607)	Caceres		Spain	10003
200	Hospital Universitario Lucus Augusti ( Site 1609)	Lugo		Spain	27003
201	Clinica Universitaria de Navarra ( Site 1600)	Madrid		Spain	28027
202	Hospital Universitario Virgen del Rocio ( Site 1604)	Sevilla		Spain	41013
203	Changhua Christian Hospital ( Site 2507)	Changhua		Taiwan	50006
204	China Medical University Hospital ( Site 2506)	Taichung		Taiwan	40447
205	Taichung Veterans General Hospital ( Site 2510)	Taichung		Taiwan	40705
206	National Cheng Kung University Hospital ( Site 2508)	Tainan		Taiwan	704
207	National Taiwan University Hospital ( Site 2502)	Taipei		Taiwan	10002
208	MacKay Memorial Hospital ( Site 2500)	Taipei		Taiwan	10449
209	Taipei Veterans General Hospital ( Site 2503)	Taipei		Taiwan	11217
210	Linkou Chang Gung Memorial Hospital ( Site 2501)	Taoyuan		Taiwan	333
211	Istanbul Acibadem University Atakent Hospital ( Site 1902)	Kucukcekmece	Istanbul	Turkey	34303
212	Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)	Ankara		Turkey	06050
213	Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)	Ankara		Turkey	06590
214	Akdeniz Universitesi Tıp Fakultesi ( Site 1901)	Antalya		Turkey	07070
215	Uludag Universitesi Tip Fakultesi ( Site 1904)	Bursa		Turkey	16059
216	Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)	Istanbul		Turkey	34093
217	Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)	Istanbul		Turkey	34147
218	Medipol Universite Hastanesi ( Site 1909)	Istanbul		Turkey	34214
219	Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)	Sakarya		Turkey	54290
220	MI Precarpathian Clinical Oncology Center ( Site 2181)	Ivano-Frankivsk	Ivano-Frankivska Oblast	Ukraine	76018
221	Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)	Kharkiv	Kharkivska Oblast	Ukraine	61024
222	Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli	Khmelnytskyi	Khmelnytska Oblast	Ukraine	29009
223	Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)	Lviv	Lvivska Oblast	Ukraine	79031
224	MI Odessa Regional Oncological Centre ( Site 2121)	Odesa	Odeska Oblast	Ukraine	65055
225	RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)	Sumy	Sumska Oblast	Ukraine	40022
226	Central City Clinical Hospital ( Site 2150)	Uzhgorod	Zakarpatska Oblast	Ukraine	88000
227	Kyiv City Clinical Oncological Center ( Site 2140)	Kyiv		Ukraine	03115

Sponsors and Collaborators

• Merck Sharp & Dohme LLC
• European Network of Gynaecological Oncological Trial Groups (ENGOT)
• Gynecologic Oncology Group

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Merck Oncology Clinical Trials Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT03740165
• Other Study ID Numbers: 7339-001; ENGOT-ov43; MK-7339-001; KEYLYNK-001; 194619; GOG-3036; 2018-001973-25
• First Posted: Nov 14, 2018
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Merck Sharp & Dohme LLC: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Paclitaxel; Docetaxel; Bevacizumab; Carboplatin; Pembrolizumab; Olaparib

Study Results

No Results Posted as of Aug 25, 2022