Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03834519
• Collaborator: (none)
• Enrollment: 793
• Locations: 193
• Arms: 2
• Anticipated Duration (Months): 47.3
• Patients Per Site: 4.1
• 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 the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.

The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to:

1. Overall Survival (OS) and

2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Biological: Pembrolizumab; Drug: Olaparib; Drug: Abiraterone acetate; Drug: Prednisone; Drug: Enzalutamide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 793 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
• Actual Study Start Date: May 2, 2019
• Actual Primary Completion Date: Mar 14, 2022
• Anticipated Study Completion Date: Apr 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pembrolizumab + Olaparib Participants receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475 KEYTRUDA® ; Drug: Olaparib; Oral tablets; Other Names: MK-7339 AZD-2281 LYNPARZA®
Active Comparator: Abiraterone + Prednisone or Enzalutamide Participants receive abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone 10 mg as one 5 mg tablet BID until progression OR Participants receive enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.	Drug: Abiraterone acetate; Oral tablets; Other Names: ZYTIGA® CB-7630 JNJ-212082 ; Drug: Prednisone; Oral tablets; Drug: Enzalutamide; Oral tablets or oral capsules; Other Names: XTANDI® MDV-3100 ASP-9785

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) [Up to approximately 40 months]

   Overall survival (OS) is defined as the time from randomization to death due to any cause.

2. Radiographic Progression-Free Survival (rPFS) [Up to approximately 40 months]

   rPFS defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). rPFS as assessed by BICR will be presented.

Secondary Outcome Measures

1. Time to Initiation of the First Subsequent Anticancer Therapy (TFST) [Up to approximately 40 months]

   TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death.

2. Objective Response Rate (ORR) [Up to approximately 40 months]

   ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

3. Duration of Response (DOR) [Up to approximately 40 months]

   DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG-modified RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

4. Time to Prostate-Specific Antigen (PSA) Progression [Up to approximately 40 months]

   Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of: ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, OR ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.

5. Time to First Symptomatic Skeletal-Related Event (SSRE) [Up to approximately 40 months]

   SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as: First use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms; Occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral); Occurrence of spinal cord compression; or Tumor-related orthopedic surgical intervention, whichever occurs first.

6. Time to Radiographic Soft Tissue Progression [Up to approximately 40 months]

   Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1. Progression is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered progression. Time to radiographic soft tissue progression as assessed by BICR will be presented.

7. Time to Pain Progression (TTPP) [Up to approximately 40 months]

   TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score. Pain progression is defined as: For participants who are asymptomatic at baseline, a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score OR initiation of opioid use for pain For participants who are symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids), a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.

8. Number of Participants Who Experience an Adverse Event (AE) [Up to approximately 40 months]

   An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

9. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [Up to approximately 40 months]

   The number of participants who discontinue study treatment due to an AE will be presented.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology

• Has prostate cancer progression while receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before screening

• Has current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by computed tomography/magnetic resonance imaging (CT/MRI)

• Has received prior treatment with abiraterone acetate OR enzalutamide, but not both

• Have disease that progressed during or after treatment with abiraterone acetate for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression)

• Participants that received abiraterone acetate for mHSPC may not have received abiraterone acetate or enzalutamide for mCRPC

• Have received docetaxel chemotherapy regimen for mCRPC and have had progressive disease during or after treatment with docetaxel

• Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)

• If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, must have been receiving stable doses before randomization

• Must agree to refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention PLUS be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic

• Contraception use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirement above, the local label requirements are to be followed.

• Has provided tumor tissue from a fresh core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed. Participants with bone-only or bone-predominant disease may provide a bone biopsy sample

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization

Exclusion Criteria:

• Has a known additional malignancy that is progressing or has required active treatment in the last 3 years

• Has an active autoimmune disease that has required systemic treatment in the past 2 years

• Has a history of (noninfectious) pneumonitis requiring steroids, or has current pneumonitis

• Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g., hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV RNA [qualitative] is detected)

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Has a history of seizure or any condition that may predispose to seizure

• Has a history of loss of consciousness within 12 months of screening

• Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

• Has (≥Grade 3) hypersensitivity to pembrolizumab and/or any of its excipients

• Has known hypersensitivity to the components or excipients in olaparib, abiraterone acetate, prednisone or prednisolone, or enzalutamide

• Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)

• Has received an anticancer monoclonal antibody (mAb) before randomization

• Has received prior treatment with olaparib or any other PARP inhibitor

• Has received prior treatment with apalutamide or darolutamide

• Has received prior treatment with enzalutamide or apalutamide for metastatic hormone-sensitive prostate cancer

• Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA (e.g., saw palmetto) before the date of randomization

• Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer

• Has received prior treatment with an 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., CTLA-4, OX-40, or CD137)

• Is currently receiving either strong or moderate inhibitors of cytochrome P450 [CYP] (CYP3A4) that cannot be discontinued for the duration of the study

• Has received a previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT) or a solid organ transplant

• Has received a live vaccine within 30 days prior to the date of randomization

• Is currently participating in or has participated in a study of an investigational agent, or has used an investigational device, within 4 weeks before the date of randomization

• Has a bone "superscan"

• Is expecting to father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph Heritage Healthcare ( Site 0069)	Fullerton	California	United States	92835
2	UCLA Hematology/Oncology - Santa Monica ( Site 0081)	Los Angeles	California	United States	90404
3	Sibley Memorial Hospital ( Site 0096)	Washington	District of Columbia	United States	20016
4	Georgia Cancer Center at Augusta University ( Site 0026)	Augusta	Georgia	United States	30912
5	Quincy Medical Group ( Site 0021)	Quincy	Illinois	United States	62301
6	Tulane Cancer Center ( Site 0066)	New Orleans	Louisiana	United States	70112
7	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)	Baltimore	Maryland	United States	21287
8	Chesapeake Urology Research Associates ( Site 0076)	Towson	Maryland	United States	21204
9	Beth Israel Deaconess Medical Ctr. ( Site 0093)	Boston	Massachusetts	United States	02215
10	Dana Farber Cancer Institute ( Site 0033)	Boston	Massachusetts	United States	02215
11	UMass Memorial Medical Center ( Site 0053)	Worcester	Massachusetts	United States	01655
12	Barbara Ann Karmanos Cancer Institute ( Site 0077)	Detroit	Michigan	United States	48201
13	Henry Ford Health System ( Site 0039)	Detroit	Michigan	United States	48202
14	St. Vincent Frontier Cancer Center ( Site 0016)	Billings	Montana	United States	59102
15	Nebraska Cancer Specialists ( Site 0034)	Omaha	Nebraska	United States	68130
16	Comprehensive Cancer Centers of Nevada ( Site 0092)	Las Vegas	Nevada	United States	89169
17	University of New Mexico Cancer Center ( Site 0048)	Albuquerque	New Mexico	United States	87131
18	Memorial Medical Center ( Site 0095)	Las Cruces	New Mexico	United States	88011
19	Associated Medical Professionals of NY ( Site 0060)	Syracuse	New York	United States	13210
20	Duke Cancer Center Cary ( Site 0010)	Cary	North Carolina	United States	27511
21	Gabrail Cancer Center-Research ( Site 0097)	Canton	Ohio	United States	44718
22	The Urology Group- Cincinnati ( Site 0094)	Cincinnati	Ohio	United States	45212
23	University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)	Cleveland	Ohio	United States	44106
24	Carolina Urologic Research Center ( Site 0070)	Myrtle Beach	South Carolina	United States	29572
25	Huntsman Cancer Institute ( Site 0002)	Salt Lake City	Utah	United States	84112
26	Virginia Cancer Institute ( Site 0052)	Richmond	Virginia	United States	23230
27	Blue Ridge Cancer Care ( Site 0086)	Roanoke	Virginia	United States	24014
28	Seattle Cancer Care Alliance ( Site 0079)	Seattle	Washington	United States	98109
29	Froedtert and Medical College of Wisconsin ( Site 0045)	Milwaukee	Wisconsin	United States	53226
30	Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)	Berazategui	Buenos Aires	Argentina	B1884BBF
31	Centro de Diagnostico Urologico ( Site 1008)	Buenos Aires	Caba	Argentina	C1120AAT
32	Hospital Britanico de Buenos Aires ( Site 1006)	Buenos Aires	Caba	Argentina	C1280AEB
33	Sanatorio Parque ( Site 1002)	Rosario	Santa Fe	Argentina	S2000DSV
34	Instituto de Investigaciones Metabolicas ( Site 1011)	Buenos Aires		Argentina	C1012AAR
35	Hospital Aleman ( Site 1004)	Buenos Aires		Argentina	C1118AAT
36	Instituto Medico Alexander Fleming ( Site 1010)	Buenos Aires		Argentina	C1426ANZ
37	CEMAIC ( Site 1014)	Cordoba		Argentina	X5008HHW
38	St. Vincent's Hospital ( Site 0158)	Darlinghurst	New South Wales	Australia	2010
39	Macquarie University ( Site 0151)	Macquarie University	New South Wales	Australia	2109
40	Port Macquarie Base Hospital ( Site 0153)	Port Macquarie	New South Wales	Australia	2444
41	Calvary Mater Newcastle ( Site 0148)	Waratah	New South Wales	Australia	2298
42	Southern Medical Day Care Centre ( Site 0160)	Wollongong	New South Wales	Australia	2500
43	Royal Brisbane and Women s Hospital ( Site 0155)	Herston	Queensland	Australia	4029
44	John Flynn Hospital & Medical Centre ( Site 0164)	Tugun	Queensland	Australia	4224
45	Box Hill Hospital ( Site 0146)	Box Hill	Victoria	Australia	3128
46	Peter MacCallum Cancer Centre ( Site 0152)	Melbourne	Victoria	Australia	3000
47	Fiona Stanley Hospital ( Site 0162)	Murdoch	Western Australia	Australia	6150
48	Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)	Linz	Oberosterreich	Austria	4020
49	Medizinische Universitat Graz ( Site 0374)	Graz	Steiermark	Austria	8036
50	SCRI-CCCIT GesmbH ( Site 0371)	Salzburg		Austria	5020
51	Medizinische Universitaet Wien ( Site 0375)	Wien		Austria	1090
52	Hospital de Caridade de Ijui ( Site 1038)	Ijui	Rio Grande Do Sul	Brazil	98700-000
53	Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
54	Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)	Itajai	Santa Catarina	Brazil	88301-215
55	Hospital de Base de Sao Jose de Rio Preto ( Site 1022)	Sao Jose do Rio Preto	Sao Paulo	Brazil	15090-000
56	IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)	São Paulo	Sao Paulo	Brazil	04014-002
57	A.C. Camargo Cancer Center ( Site 1026)	Sao Paulo		Brazil	01509-900
58	Cross Cancer Institute ( Site 0110)	Edmonton	Alberta	Canada	T6G 1Z2
59	BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)	Kelowna	British Columbia	Canada	V1Y 5L3
60	BC Cancer-Vancouver Center ( Site 0112)	Vancouver	British Columbia	Canada	V5Z 4E6
61	Nova Scotia Health Authority QEII-HSC ( Site 0114)	Halifax	Nova Scotia	Canada	B3H 2Y9
62	William Osler Health System (Brampton Civic Hospital) ( Site 0121)	Brampton	Ontario	Canada	L6R 3J7
63	Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)	Hamilton	Ontario	Canada	L8V 5C2
64	Princess Margaret Cancer Centre ( Site 0107)	Toronto	Ontario	Canada	M5G 2M9
65	CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)	Rimouski	Quebec	Canada	G5L 5T1
66	CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)	Sherbrooke	Quebec	Canada	J1H 5N4
67	CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)	Quebec		Canada	G1R 2J6
68	Centro Investigación del Cáncer James Lind ( Site 1041)	Temuco	Araucania	Chile	4780000
69	Rey y Oreilly Limitada ( Site 1048)	Temuco	Araucania	Chile	4810148
70	Fundacion Arturo Lopez Perez ( Site 1049)	Santiago	Region M. De Santiago	Chile	7500921
71	Pontificia Universidad Catolica de Chile ( Site 1047)	Santiago	Region M. De Santiago	Chile	8330032
72	Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)	Santiago	Region M. De Santiago	Chile	8420383
73	C.H. de Saint Quentin ( Site 0481)	Saint Quentin	Aisne	France	02321
74	Clinique Sainte Anne ( Site 0431)	Strasbourg	Alsace	France	67000
75	Centre Jean Perrin ( Site 0434)	Clermont-Ferrand	Auvergne	France	63011
76	Institut Paoli Calmettes ( Site 0419)	Marseille	Bouches-du-Rhone	France	13009
77	CHU de Brest -Site Hopital Morvan ( Site 0441)	Brest	Bretagne	France	29200
78	CHU Jean Minjoz ( Site 0423)	Besancon	Doubs	France	25000
79	Institut Bergonie ( Site 0421)	Bordeaux	Gironde	France	33076
80	Institut Claudius Regaud IUCT Oncopole ( Site 0418)	Toulouse	Haute-Garonne	France	31059
81	Hopital Foch ( Site 0428)	Suresnes	Hauts-de-Seine	France	92150
82	Institut Regional du Cancer de Montpellier - ICM ( Site 0443)	Montpellier	Herault	France	34298
83	Institut De Cancerologie De L Ouest ( Site 0448)	Saint Herblain	Loire-Atlantique	France	44805
84	Centre Hospitalier Regional du Orleans ( Site 0430)	Orleans	Loiret	France	45100
85	Centre D Oncologie de Gentilly ( Site 0432)	Nancy	Meurthe-et-Moselle	France	54100
86	Centre Leon Berard ( Site 0422)	Lyon	Rhone	France	69373
87	C.H.U. Lyon Sud ( Site 0436)	Pierre Benite	Rhone	France	69310
88	CHU Amiens Picardie Site Sud Amiens ( Site 0438)	Amiens	Somme	France	80000
89	Institut Gustave Roussy ( Site 0416)	Villejuif	Val-de-Marne	France	94800
90	Institut Sainte Catherine ( Site 0447)	Avignon	Vaucluse	France	84000
91	Institut Mutualiste Montsouris ( Site 0446)	Paris		France	75014
92	Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)	Freiburg	Baden-Wurttemberg	Germany	79106
93	Universitaetsklinikum in Mannheim ( Site 0314)	Mannheim	Baden-Wurttemberg	Germany	68167
94	Studienpraxis Urologie ( Site 0309)	Nuertingen	Baden-Wurttemberg	Germany	72622
95	Universitaetsklinik fuer Urologie ( Site 0307)	Tuebingen	Baden-Wurttemberg	Germany	72076
96	Universitaetsklinikum Erlangen ( Site 0303)	Erlangen	Bayern	Germany	91054
97	Klinikum Rechts der Isar ( Site 0300)	Muenchen	Bayern	Germany	81675
98	Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)	Nuernberg	Bayern	Germany	90419
99	Universitaetsklinikum Duesseldorf ( Site 0306)	Duesseldorf	Nordrhein-Westfalen	Germany	40225
100	Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)	Trier	Rheinland-Pfalz	Germany	54292
101	Universitaetsklinikum Jena ( Site 0305)	Jena	Thuringen	Germany	07747
102	Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)	Berlin		Germany	10117
103	Tallaght University Hospital ( Site 0730)	Dublin		Ireland	D24 NROA
104	Mid Western Cancer Centre ( Site 0728)	Limerick		Ireland
105	Ha Emek Medical Center ( Site 0548)	Afula		Israel	1834111
106	Assaf Harofe ( Site 0547)	Be'er- Ya'akov		Israel	7030001
107	Soroka Medical Center ( Site 0549)	Beer Sheva		Israel	8410101
108	Rambam Medical Center ( Site 0543)	Haifa		Israel	3109601
109	Hadassah Ein Kerem Medical Center ( Site 0546)	Jerusalem		Israel	9112001
110	Meir Medical Center ( Site 0544)	Kfar Saba		Israel	4428164
111	Rabin Medical Center ( Site 0545)	Petach-Tikwa		Israel	4941492
112	Chaim Sheba Medical Center ( Site 0541)	Ramat Gan		Israel	5262000
113	Sourasky Medical Center ( Site 0542)	Tel-Aviv		Israel	6423906
114	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)	Meldola	Emilia-Romagna	Italy	47014
115	Istituto Clinico Humanitas Research Hospital ( Site 0452)	Rozzano	Lombardia	Italy	20089
116	Medical Oncology Ospedale San Donato ( Site 0461)	Arezzo		Italy	52100
117	Policlinico S.Orsola-Malpighi ( Site 0453)	Bologna		Italy	40138
118	Azienda Ospedaliera Cannizzaro ( Site 0458)	Catania		Italy	95126
119	Azienda Ospedaliera San Camillo Forlanini ( Site 0455)	Roma		Italy	00152
120	Fondazione Policlinico Universitario A. Gemelli ( Site 0463)	Roma		Italy	00168
121	Azienda Ospedaliera Santa Maria Terni ( Site 0456)	Terni		Italy	05100
122	Presidio Ospedaliero Santa Chiara ( Site 0451)	Trento		Italy	38122
123	Fujita Health University Hospital ( Site 0724)	Toyoake	Aichi	Japan	470-1192
124	National Cancer Center Hospital East ( Site 0702)	Kashiwa	Chiba	Japan	277-8577
125	Toho University Sakura Medical Center ( Site 0703)	Sakura	Chiba	Japan	285-8741
126	National Hospital Organization Shikoku Cancer Center ( Site 0716)	Matsuyama	Ehime	Japan	791-0280
127	Kobe City Medical Center General Hospital ( Site 0726)	Kobe	Hyogo	Japan	650-0047
128	Kanazawa University Hospital ( Site 0701)	Kanazawa	Ishikawa	Japan	920-8641
129	Kitasato University Hospital ( Site 0705)	Sagamihara	Kanagawa	Japan	252-0375
130	Yokohama City University Medical Center ( Site 0706)	Yokohama	Kanagawa	Japan	232-0024
131	Nara Medical University Hospital ( Site 0715)	Kashihara	Nara	Japan	634-8522
132	Kindai University Hospital ( Site 0714)	Osakasayama	Osaka	Japan	589-8511
133	Osaka University Hospital ( Site 0713)	Suita	Osaka	Japan	565-0871
134	Saitama Medical University International Medical Center ( Site 0708)	Hidaka	Saitama	Japan	350-1298
135	Dokkyo Medical University Saitama Medical Center ( Site 0707)	Koshigaya	Saitama	Japan	343-8555
136	Fuji City General Hospital ( Site 0725)	Fuji	Shizuoka	Japan	417-8567
137	Hamamatsu University Hospital ( Site 0720)	Hamamatsu	Shizuoka	Japan	431-3192
138	Yamaguchi University Hospital ( Site 0717)	Ube	Yamaguchi	Japan	755-8505
139	Chiba Cancer Center ( Site 0704)	Chiba		Japan	260-8717
140	Kyushu University Hospital ( Site 0718)	Fukuoka		Japan	812-8582
141	University of Miyazaki Hospital ( Site 0721)	Miyazaki		Japan	889-1692
142	Nagano Municipal Hospital ( Site 0723)	Nagano		Japan	381-8551
143	Nagasaki University Hospital ( Site 0719)	Nagasaki		Japan	852-8501
144	Osaka International Cancer Institute ( Site 0722)	Osaka		Japan	541-8567
145	Toranomon Hospital ( Site 0711)	Tokyo		Japan	105-8470
146	Nippon Medical School Hospital ( Site 0709)	Tokyo		Japan	113-8603
147	Keio University Hospital ( Site 0710)	Tokyo		Japan	160-8582
148	Chonnam National University Hwasun Hospital ( Site 0174)	Hwasun Gun	Jeonranamdo	Korea, Republic of	58128
149	National Cancer Center ( Site 0176)	Goyang-si	Kyonggi-do	Korea, Republic of	10408
150	Asan Medical Center ( Site 0171)	Songpagu	Seoul	Korea, Republic of	05505
151	Severance Hospital Yonsei University Health System ( Site 0173)	Seoul		Korea, Republic of	03722
152	Samsung Medical Center ( Site 0172)	Seoul		Korea, Republic of	06351
153	Medisch Centrum Leeuwarden ( Site 0477)	Leeuwarden	Fryslan	Netherlands	8934 AD
154	Radboud University Medical Center ( Site 0470)	Nijmegen	Gelderland	Netherlands	6525 GA
155	Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)	Amsterdam	Noord-Holland	Netherlands	1066 CX
156	Vrije Universiteit Medisch Centrum ( Site 0479)	Amsterdam	Noord-Holland	Netherlands	1081 HV
157	Spaarne Ziekenhuis ( Site 0473)	Hoofddorp	Noord-Holland	Netherlands	2134 TM
158	Ziekenhuisgroep Twente ( Site 0469)	Hengelo	Overijssel	Netherlands	7555 DL
159	Haaglanden MC - locatie Antoniushove ( Site 0471)	Leidschendam	Zuid-Holland	Netherlands	2262 BA
160	Erasmus MC ( Site 0475)	Rotterdam	Zuid-Holland	Netherlands	3015 GD
161	Franciscus Gasthuis en Vlietland ( Site 0489)	Schiedam	Zuid-Holland	Netherlands	3118 JH
162	Auckland City Hospital ( Site 0193)	Auckland		New Zealand	1023
163	Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)	Chelyabinsk	Chelyabinskaya Oblast	Russian Federation	454087
164	Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)	Krasnoyarsk	Krasnoyarskiy Kray	Russian Federation	660133
165	Russian Scientific Center of Roentgenoradiology ( Site 0559)	Moscow	Moskva	Russian Federation	117997
166	Central Clinical Hospital with Polyclinic ( Site 0562)	Moscow	Moskva	Russian Federation	121359
167	Omsk Clinical Oncology Dispensary ( Site 0568)	Omsk	Omskaya Oblast	Russian Federation	644013
168	SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)	Samara	Samarskaya Oblast	Russian Federation	443031
169	SBHI Leningrad Regional Oncology Dispensary ( Site 0588)	Saint Petersburg	Sankt-Peterburg	Russian Federation	191104
170	Clinical Research Center of specialized types medical care-Oncology ( Site 0570)	Saint Petersburg	Sankt-Peterburg	Russian Federation	197758
171	Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)	Saint Petersburg	Sankt-Peterburg	Russian Federation	197758
172	Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)	Tomsk	Tomskaya Oblast	Russian Federation	634028
173	Instituto Catalan de Oncologia - ICO ( Site 0330)	L Hospitalet De Llobregat	Barcelona	Spain	08908
174	Hospital Parc Tauli ( Site 0335)	Sabadell	Barcelona	Spain	08208
175	Hospital San Pedro de Alcantara ( Site 0326)	Caceres	Extremadura	Spain	10003
176	Hospital Josep Trueta ( Site 0321)	Girona	Gerona	Spain	17007
177	Hospital Quiron Madrid ( Site 0325)	Pozuelo de Alarcon	Madrid	Spain	28223
178	Hospital del Mar ( Site 0333)	Barcelona		Spain	08003
179	Hospital General Universitari Vall d Hebron ( Site 0334)	Barcelona		Spain	08035
180	Hospital Clinic ( Site 0323)	Barcelona		Spain	08036
181	Hospital Universitario Virgen de la Victoria ( Site 0337)	Malaga		Spain	29016
182	National Cheng Kung University Hospital ( Site 0134)	Tainen	Tainan	Taiwan	704
183	China Medical University Hospital ( Site 0132)	Taichung		Taiwan	40447
184	Taichung Veterans General Hospital ( Site 0133)	Taichung		Taiwan	407
185	National Taiwan University Hospital ( Site 0131)	Taipei		Taiwan	10048
186	Taipei Veterans General Hospital ( Site 0135)	Taipei		Taiwan	11217
187	University Hospitals Bristol NHS Foundation Trust ( Site 0530)	Bristol	Bristol, City Of	United Kingdom	BS2 8ED
188	Cambridge University Hospitals NHS Trust ( Site 0540)	Cambridge	Cambridgeshire	United Kingdom	CB2 0QQ
189	Torbay Hospital ( Site 0532)	Torquay	Devon	United Kingdom	TQ2 7AA
190	Royal Marsden Hospital ( Site 0526)	Sutton	England	United Kingdom	SM2 5PT
191	Musgrove Park Hospital ( Site 0537)	Taunton	England	United Kingdom	TA1 5DA
192	University of North Midlands NHS Foundation Trust ( Site 0527)	Stoke-on-Trent	Staffordshire	United Kingdom	ST4 6QG
193	Mount Vernon Cancer Centre ( Site 0536)	Northwood		United Kingdom	HA6 2RN

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Merck Oncology Clinical Trial Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT03834519
• Other Study ID Numbers: 7339-010; MK-7339-010; KEYLYNK-010; 194832; 2018-004118-16
• First Posted: Feb 8, 2019
• Last Update Posted: May 20, 2022
• Last Verified: May 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 Cell Death 1 Ligand 1(PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Pembrolizumab; Olaparib; Abiraterone Acetate

Study Results

No Results Posted as of May 20, 2022