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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7339-010 | Other Identifier | MSD | |
| KEYLYNK-010 | Other Identifier | MSD | |
| 2018-004118-16 | EudraCT Number |
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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:
As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per standard of care (SOC) schedule. In addition, electronic patient-reported outcome (ePRO) assessments will no longer be performed and biomarker samples will no longer be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + Olaparib | Experimental | Participants will 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). |
|
| Next-generation Hormonal Agent Monotherapy (NHA) | Active Comparator | Participants will receive a single NHA, which will be either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | Up to ~31 months |
| Radiographic Progression-Free Survival (rPFS) | rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified 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 have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | Up to ~26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Initiation of the First Subsequent Anticancer Therapy (TFST) | TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | Up to ~26 months |
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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 received docetaxel chemotherapy regimen for metastatic castration-resistant prostate cancer (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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Heritage Healthcare ( Site 0069) | Fullerton | California | 92835 | United States | ||
| UCLA Hematology/Oncology - Santa Monica ( Site 0081) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37290035 | Result | Antonarakis ES, Park SH, Goh JC, Shin SJ, Lee JL, Mehra N, McDermott R, Sala-Gonzalez N, Fong PC, Greil R, Retz M, Sade JP, Yanez P, Huang YH, Begbie SD, Gafanov RA, De Santis M, Rosenbaum E, Kolinsky MP, Rey F, Chiu KY, Roubaud G, Kramer G, Sumitomo M, Massari F, Suzuki H, Qiu P, Zhang J, Kim J, Poehlein CH, Yu EY. Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial. J Clin Oncol. 2023 Aug 1;41(22):3839-3850. doi: 10.1200/JCO.23.00233. Epub 2023 Jun 8. | |
| 40685311 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Participants randomized to the next-generation hormonal agent monotherapy (NHA) arm received one of two NHA treatments, per protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab + Olaparib | Participants received 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). |
| FG001 | Next-generation Hormonal Agent Monotherapy (NHA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2022 |
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| Olaparib | Drug | Oral tablets |
|
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| Abiraterone acetate | Drug | Oral tablets |
|
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| Prednisone | Drug | Oral tablets |
|
| Enzalutamide | Drug | Oral tablets or oral capsules |
|
|
| Prednisolone | Drug | Oral tablets |
|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions per RECIST 1.1 and no evidence of disease (NED) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented. | Up to ~31 months |
| Duration of Response (DOR) | 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 ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented. | Up to ~26 months |
| Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of: 1) ≥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 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | Up to ~31 months |
| Time to First Symptomatic Skeletal-Related Event (SSRE) | SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:
| Up to ~31 months |
| Time to Radiographic Soft Tissue Progression | 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 is presented. | Up to ~31 months |
| Time to Pain Progression (TTPP) | 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:
Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment. | Up to ~31 months |
| Number of Participants Who Experience an Adverse Event (AE) | 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. The number of participants who experienced an adverse event are presented. | Up to ~55 months |
| Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | 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. The number of participants who discontinue study treatment due to an AE are presented. | Up to ~1461 Days |
| Los Angeles |
| California |
| 90404 |
| United States |
| Sibley Memorial Hospital ( Site 0096) | Washington D.C. | District of Columbia | 20016 | United States |
| Georgia Cancer Center at Augusta University ( Site 0026) | Augusta | Georgia | 30912 | United States |
| Quincy Medical Group ( Site 0021) | Quincy | Illinois | 62301 | United States |
| Tulane Cancer Center ( Site 0066) | New Orleans | Louisiana | 70112 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005) | Baltimore | Maryland | 21287 | United States |
| Chesapeake Urology Research Associates ( Site 0076) | Towson | Maryland | 21204 | United States |
| Beth Israel Deaconess Medical Ctr. ( Site 0093) | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute ( Site 0033) | Boston | Massachusetts | 02215 | United States |
| UMass Memorial Medical Center ( Site 0053) | Worcester | Massachusetts | 01655 | United States |
| Barbara Ann Karmanos Cancer Institute ( Site 0077) | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System ( Site 0039) | Detroit | Michigan | 48202 | United States |
| St. Vincent Frontier Cancer Center ( Site 0016) | Billings | Montana | 59102 | United States |
| Nebraska Cancer Specialists ( Site 0034) | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada ( Site 0092) | Las Vegas | Nevada | 89169 | United States |
| University of New Mexico Cancer Center ( Site 0048) | Albuquerque | New Mexico | 87131 | United States |
| Memorial Medical Center ( Site 0095) | Las Cruces | New Mexico | 88011 | United States |
| Associated Medical Professionals of NY ( Site 0060) | Syracuse | New York | 13210 | United States |
| Duke Cancer Center Cary ( Site 0010) | Cary | North Carolina | 27511 | United States |
| Gabrail Cancer Center-Research ( Site 0097) | Canton | Ohio | 44718 | United States |
| The Urology Group- Cincinnati ( Site 0094) | Cincinnati | Ohio | 45212 | United States |
| University Hospitals of Cleveland Seidman Cancer Center ( Site 0036) | Cleveland | Ohio | 44106 | United States |
| Carolina Urologic Research Center ( Site 0070) | Myrtle Beach | South Carolina | 29572 | United States |
| Huntsman Cancer Institute ( Site 0002) | Salt Lake City | Utah | 84112 | United States |
| Virginia Cancer Institute ( Site 0052) | Richmond | Virginia | 23230 | United States |
| Blue Ridge Cancer Care ( Site 0086) | Roanoke | Virginia | 24014 | United States |
| Seattle Cancer Care Alliance ( Site 0079) | Seattle | Washington | 98109 | United States |
| Froedtert and Medical College of Wisconsin ( Site 0045) | Milwaukee | Wisconsin | 53226 | United States |
| Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013) | Berazategui | Buenos Aires | B1884BBF | Argentina |
| Centro de Diagnostico Urologico ( Site 1008) | Buenos Aires | Buenos Aires F.D. | C1120AAT | Argentina |
| Hospital Britanico de Buenos Aires ( Site 1006) | Buenos Aires | Buenos Aires F.D. | C1280AEB | Argentina |
| Sanatorio Parque ( Site 1002) | Rosario | Santa Fe Province | S2000DSV | Argentina |
| Instituto de Investigaciones Metabolicas ( Site 1011) | Buenos Aires | C1012AAR | Argentina |
| Hospital Aleman ( Site 1004) | Buenos Aires | C1118AAT | Argentina |
| Instituto Medico Alexander Fleming ( Site 1010) | Buenos Aires | C1426ANZ | Argentina |
| CEMAIC ( Site 1014) | Córdoba | X5008HHW | Argentina |
| St. Vincent's Hospital ( Site 0158) | Darlinghurst | New South Wales | 2010 | Australia |
| Macquarie University ( Site 0151) | Macquarie University | New South Wales | 2109 | Australia |
| Port Macquarie Base Hospital ( Site 0153) | Port Macquarie | New South Wales | 2444 | Australia |
| Calvary Mater Newcastle ( Site 0148) | Waratah | New South Wales | 2298 | Australia |
| Southern Medical Day Care Centre ( Site 0160) | Wollongong | New South Wales | 2500 | Australia |
| Royal Brisbane and Women s Hospital ( Site 0155) | Herston | Queensland | 4029 | Australia |
| John Flynn Hospital & Medical Centre ( Site 0164) | Tugun | Queensland | 4224 | Australia |
| Box Hill Hospital ( Site 0146) | Box Hill | Victoria | 3128 | Australia |
| Peter MacCallum Cancer Centre ( Site 0152) | Melbourne | Victoria | 3000 | Australia |
| Fiona Stanley Hospital ( Site 0162) | Murdoch | Western Australia | 6150 | Australia |
| Medizinische Universitat Graz ( Site 0374) | Graz | Styria | 8036 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen ( Site 0373) | Linz | Upper Austria | 4020 | Austria |
| SCRI-CCCIT GesmbH ( Site 0371) | Salzburg | 5020 | Austria |
| Medizinische Universitaet Wien ( Site 0375) | Vienna | 1090 | Austria |
| Hospital de Caridade de Ijui ( Site 1038) | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021) | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035) | Itajaí | Santa Catarina | 88301-215 | Brazil |
| Hospital de Base de Sao Jose de Rio Preto ( Site 1022) | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040) | São Paulo | São Paulo | 04014-002 | Brazil |
| A.C. Camargo Cancer Center ( Site 1026) | São Paulo | 01509-900 | Brazil |
| Cross Cancer Institute ( Site 0110) | Edmonton | Alberta | T6G 1Z2 | Canada |
| BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113) | Kelowna | British Columbia | V1Y 5L3 | Canada |
| BC Cancer-Vancouver Center ( Site 0112) | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Nova Scotia Health Authority QEII-HSC ( Site 0114) | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| William Osler Health System (Brampton Civic Hospital) ( Site 0121) | Brampton | Ontario | L6R 3J7 | Canada |
| Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116) | Hamilton | Ontario | L8V 5C2 | Canada |
| Princess Margaret Cancer Centre ( Site 0107) | Toronto | Ontario | M5G 2M9 | Canada |
| CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103) | Québec | Quebec | G1R 2J6 | Canada |
| CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102) | Rimouski | Quebec | G5L 5T1 | Canada |
| CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105) | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Centro Investigación del Cáncer James Lind ( Site 1041) | Temuco | Araucania | 4780000 | Chile |
| Rey y Oreilly Limitada ( Site 1048) | Temuco | Araucania | 4810148 | Chile |
| Fundacion Arturo Lopez Perez ( Site 1049) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Pontificia Universidad Catolica de Chile ( Site 1047) | Santiago | Region M. de Santiago | 8330032 | Chile |
| Bradford Hill Centro de Investigaciones Clinicas ( Site 1044) | Santiago | Region M. de Santiago | 8420383 | Chile |
| C.H. de Saint Quentin ( Site 0481) | Saint-Quentin | Aisne | 02321 | France |
| Clinique Sainte Anne ( Site 0431) | Strasbourg | Alsace | 67000 | France |
| Centre Jean Perrin ( Site 0434) | Clermont-Ferrand | Auvergne | 63011 | France |
| Institut Paoli Calmettes ( Site 0419) | Marseille | Bouches-du-Rhone | 13009 | France |
| CHU de Brest -Site Hopital Morvan ( Site 0441) | Brest | Brittany Region | 29200 | France |
| CHU Jean Minjoz ( Site 0423) | Besançon | Doubs | 25000 | France |
| Institut Bergonie ( Site 0421) | Bordeaux | Gironde | 33076 | France |
| Institut Claudius Regaud IUCT Oncopole ( Site 0418) | Toulouse | Haute-Garonne | 31059 | France |
| Hopital Foch ( Site 0428) | Suresnes | Hauts-de-Seine | 92150 | France |
| Institut Regional du Cancer de Montpellier - ICM ( Site 0443) | Montpellier | Herault | 34298 | France |
| Institut De Cancerologie De L Ouest ( Site 0448) | Saint-Herblain | Loire-Atlantique | 44805 | France |
| Centre Hospitalier Regional du Orleans ( Site 0430) | Orléans | Loiret | 45100 | France |
| Centre D Oncologie de Gentilly ( Site 0432) | Nancy | Meurthe-et-Moselle | 54100 | France |
| Centre Leon Berard ( Site 0422) | Lyon | Rhone | 69373 | France |
| C.H.U. Lyon Sud ( Site 0436) | Pierre-Bénite | Rhone | 69310 | France |
| CHU Amiens Picardie Site Sud Amiens ( Site 0438) | Amiens | Somme | 80000 | France |
| Institut Gustave Roussy ( Site 0416) | Villejuif | Val-de-Marne | 94800 | France |
| Institut Sainte Catherine ( Site 0447) | Avignon | Vaucluse | 84000 | France |
| Institut Mutualiste Montsouris ( Site 0446) | Paris | 75014 | France |
| Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304) | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitaetsklinikum in Mannheim ( Site 0314) | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Studienpraxis Urologie ( Site 0309) | Nürtingen | Baden-Wurttemberg | 72622 | Germany |
| Universitaetsklinik fuer Urologie ( Site 0307) | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitaetsklinikum Erlangen ( Site 0303) | Erlangen | Bavaria | 91054 | Germany |
| Klinikum Rechts der Isar ( Site 0300) | Munich | Bavaria | 81675 | Germany |
| Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318) | Nuremberg | Bavaria | 90419 | Germany |
| Universitaetsklinikum Duesseldorf ( Site 0306) | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Krankenhaus der Barmherzigen Brueder Trier ( Site 0310) | Trier | Rhineland-Palatinate | 54292 | Germany |
| Universitaetsklinikum Jena ( Site 0305) | Jena | Thuringia | 07747 | Germany |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301) | Berlin | 10117 | Germany |
| Tallaght University Hospital ( Site 0730) | Dublin | D24 NROA | Ireland |
| Mid Western Cancer Centre ( Site 0728) | Limerick | Ireland |
| Ha Emek Medical Center ( Site 0548) | Afula | 1834111 | Israel |
| Soroka Medical Center ( Site 0549) | Beersheba | 8410101 | Israel |
| Assaf Harofe ( Site 0547) | Be’er Ya‘aqov | 7030001 | Israel |
| Rambam Medical Center ( Site 0543) | Haifa | 3109601 | Israel |
| Hadassah Ein Kerem Medical Center ( Site 0546) | Jerusalem | 9112001 | Israel |
| Meir Medical Center ( Site 0544) | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center ( Site 0545) | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center ( Site 0541) | Ramat Gan | 5262000 | Israel |
| Sourasky Medical Center ( Site 0542) | Tel Aviv | 6423906 | Israel |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462) | Meldola | Emilia-Romagna | 47014 | Italy |
| Istituto Clinico Humanitas Research Hospital ( Site 0452) | Rozzano | Lombardy | 20089 | Italy |
| Medical Oncology Ospedale San Donato ( Site 0461) | Arezzo | 52100 | Italy |
| Policlinico S.Orsola-Malpighi ( Site 0453) | Bologna | 40138 | Italy |
| Azienda Ospedaliera Cannizzaro ( Site 0458) | Catania | 95126 | Italy |
| Azienda Ospedaliera San Camillo Forlanini ( Site 0455) | Roma | 00152 | Italy |
| Fondazione Policlinico Universitario A. Gemelli ( Site 0463) | Roma | 00168 | Italy |
| Azienda Ospedaliera Santa Maria Terni ( Site 0456) | Terni | 05100 | Italy |
| Presidio Ospedaliero Santa Chiara ( Site 0451) | Trento | 38122 | Italy |
| Fujita Health University Hospital ( Site 0724) | Toyoake | Aichi-ken | 470-1192 | Japan |
| National Cancer Center Hospital East ( Site 0702) | Kashiwa | Chiba | 277-8577 | Japan |
| Toho University Sakura Medical Center ( Site 0703) | Sakura | Chiba | 285-8741 | Japan |
| National Hospital Organization Shikoku Cancer Center ( Site 0716) | Matsuyama | Ehime | 791-0280 | Japan |
| Kobe City Medical Center General Hospital ( Site 0726) | Kobe | Hyōgo | 650-0047 | Japan |
| Kanazawa University Hospital ( Site 0701) | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kitasato University Hospital ( Site 0705) | Sagamihara | Kanagawa | 252-0375 | Japan |
| Yokohama City University Medical Center ( Site 0706) | Yokohama | Kanagawa | 232-0024 | Japan |
| Nara Medical University Hospital ( Site 0715) | Kashihara | Nara | 634-8522 | Japan |
| Kindai University Hospital ( Site 0714) | Sayama | Osaka | 589-8511 | Japan |
| Osaka University Hospital ( Site 0713) | Suita | Osaka | 565-0871 | Japan |
| Saitama Medical University International Medical Center ( Site 0708) | Hidaka | Saitama | 350-1298 | Japan |
| Dokkyo Medical University Saitama Medical Center ( Site 0707) | Koshigaya | Saitama | 343-8555 | Japan |
| Fuji City General Hospital ( Site 0725) | Fuji | Shizuoka | 417-8567 | Japan |
| Hamamatsu University Hospital ( Site 0720) | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Yamaguchi University Hospital ( Site 0717) | Ube | Yamaguchi | 755-8505 | Japan |
| Chiba Cancer Center ( Site 0704) | Chiba | 260-8717 | Japan |
| Kyushu University Hospital ( Site 0718) | Fukuoka | 812-8582 | Japan |
| University of Miyazaki Hospital ( Site 0721) | Miyazaki | 889-1692 | Japan |
| Nagano Municipal Hospital ( Site 0723) | Nagano | 381-8551 | Japan |
| Nagasaki University Hospital ( Site 0719) | Nagasaki | 852-8501 | Japan |
| Osaka International Cancer Institute ( Site 0722) | Osaka | 541-8567 | Japan |
| Toranomon Hospital ( Site 0711) | Tokyo | 105-8470 | Japan |
| Nippon Medical School Hospital ( Site 0709) | Tokyo | 113-8603 | Japan |
| Keio University Hospital ( Site 0710) | Tokyo | 160-8582 | Japan |
| Radboud University Medical Center ( Site 0470) | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Antoni van Leeuwenhoek Ziekenhuis ( Site 0480) | Amsterdam | North Holland | 1066 CX | Netherlands |
| Vrije Universiteit Medisch Centrum ( Site 0479) | Amsterdam | North Holland | 1081 HV | Netherlands |
| Spaarne Ziekenhuis ( Site 0473) | Hoofddorp | North Holland | 2134 TM | Netherlands |
| Ziekenhuisgroep Twente ( Site 0469) | Hengelo | Overijssel | 7555 DL | Netherlands |
| Medisch Centrum Leeuwarden ( Site 0477) | Leeuwarden | Provincie Friesland | 8934 AD | Netherlands |
| Haaglanden MC - locatie Antoniushove ( Site 0471) | Leidschendam | South Holland | 2262 BA | Netherlands |
| Erasmus MC ( Site 0475) | Rotterdam | South Holland | 3015 GD | Netherlands |
| Franciscus Gasthuis en Vlietland ( Site 0489) | Schiedam | South Holland | 3118 JH | Netherlands |
| Auckland City Hospital ( Site 0193) | Auckland | 1023 | New Zealand |
| Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565) | Chelyabinsk | Chelyabinsk Oblast | 454087 | Russia |
| Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585) | Krasnoyarsk | Krasnoyarsk Krai | 660133 | Russia |
| Russian Scientific Center of Roentgenoradiology ( Site 0559) | Moscow | Moscow | 117997 | Russia |
| Central Clinical Hospital with Polyclinic ( Site 0562) | Moscow | Moscow | 121359 | Russia |
| Omsk Clinical Oncology Dispensary ( Site 0568) | Omsk | Omsk Oblast | 644013 | Russia |
| SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576) | Samara | Samara Oblast | 443031 | Russia |
| SBHI Leningrad Regional Oncology Dispensary ( Site 0588) | Saint Petersburg | Sankt-Peterburg | 191104 | Russia |
| Clinical Research Center of specialized types medical care-Oncology ( Site 0570) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579) | Tomsk | Tomsk Oblast | 634028 | Russia |
| Chonnam National University Hwasun Hospital ( Site 0174) | Hwasun Gun | Jeonranamdo | 58128 | South Korea |
| National Cancer Center ( Site 0176) | Goyang-si | Kyonggi-do | 10408 | South Korea |
| Asan Medical Center ( Site 0171) | Songpagu | Seoul | 05505 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 0173) | Seoul | 03722 | South Korea |
| Samsung Medical Center ( Site 0172) | Seoul | 06351 | South Korea |
| Instituto Catalan de Oncologia - ICO ( Site 0330) | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Parc Tauli ( Site 0335) | Sabadell | Barcelona | 08208 | Spain |
| Hospital San Pedro de Alcantara ( Site 0326) | Cáceres | Extremadura | 10003 | Spain |
| Hospital Josep Trueta ( Site 0321) | Girona | Gerona | 17007 | Spain |
| Hospital Quiron Madrid ( Site 0325) | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital del Mar ( Site 0333) | Barcelona | 08003 | Spain |
| Hospital General Universitari Vall d Hebron ( Site 0334) | Barcelona | 08035 | Spain |
| Hospital Clinic ( Site 0323) | Barcelona | 08036 | Spain |
| Hospital Universitario Virgen de la Victoria ( Site 0337) | Málaga | 29016 | Spain |
| National Cheng Kung University Hospital ( Site 0134) | Tainen | Tainan | 704 | Taiwan |
| China Medical University Hospital ( Site 0132) | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital ( Site 0133) | Taichung | 407 | Taiwan |
| National Taiwan University Hospital ( Site 0131) | Taipei | 10048 | Taiwan |
| Taipei Veterans General Hospital ( Site 0135) | Taipei | 11217 | Taiwan |
| University Hospitals Bristol NHS Foundation Trust ( Site 0530) | Bristol | Bristol, City of | BS2 8ED | United Kingdom |
| Cambridge University Hospitals NHS Trust ( Site 0540) | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Torbay Hospital ( Site 0532) | Torquay | Devon | TQ2 7AA | United Kingdom |
| Royal Marsden Hospital ( Site 0526) | Sutton | England | SM2 5PT | United Kingdom |
| Musgrove Park Hospital ( Site 0537) | Taunton | England | TA1 5DA | United Kingdom |
| University of North Midlands NHS Foundation Trust ( Site 0527) | Stoke-on-Trent | Staffordshire | ST4 6QG | United Kingdom |
| Mount Vernon Cancer Centre ( Site 0536) | Northwood | HA6 2RN | United Kingdom |
| Derived |
| Mehra N, Antonarakis ES, Park SH, Goh JC, McDermott R, Sala Gonzalez N, Fong PC, Greil R, De Santis M, Yanez PE, Huang YH, Begbie SD, Rey F, Kramer G, Suzuki H, Saretsky TL, Ghate SR, Cui Y, Hosius C, Yu EY. Patient-reported Outcomes in KEYLYNK-010: Pembrolizumab Plus Olaparib Versus Abiraterone or Enzalutamide for Participants with Biomarker-unselected, Previously Treated Metastatic Castration-resistant Prostate Cancer. Eur Urol Oncol. 2025 Aug;8(4):1030-1040. doi: 10.1016/j.euo.2025.04.018. Epub 2025 Jul 19. |
| Plain Language Summary | View source |
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received 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. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab + Olaparib | Participants received 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). |
| BG001 | Next-generation Hormonal Agent Monotherapy (NHA) | Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Measurable Response Evaluation Criteria in Solid Tumors Version 1.1 Disease Status at Baseline | Measurable disease at baseline is defined as having disease that is Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)-measurable lesions per blinded independent central review (BICR). | Count of Participants | Participants |
| |||||||||||||||
| Prior Use of NHA Treatment | Prior use of NHA treatment was defined as prior treatment with Abiraterone only, Enzalutamide only, or Abiraterone and Enzalutamide. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to ~31 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Radiographic Progression-Free Survival (rPFS) | rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified 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 have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to ~26 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Initiation of the First Subsequent Anticancer Therapy (TFST) | TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to ~26 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions per RECIST 1.1 and no evidence of disease (NED) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented. | All randomized participants who had measurable disease at baseline. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to ~31 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | 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 ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented. | All randomized participants who experience a confirmed CR or PR and had measurable disease at baseline. | Posted | Median | 95% Confidence Interval | Months | Up to ~26 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of: 1) ≥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 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to ~31 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Symptomatic Skeletal-Related Event (SSRE) | SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:
| All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to ~31 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Radiographic Soft Tissue Progression | 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 is presented. | All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to ~31 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Pain Progression (TTPP) | 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:
Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment. | All participants who have at least 1 assessment available and have received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Up to ~31 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | 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. The number of participants who experienced an adverse event are presented. | All randomized participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Up to ~55 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | 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. The number of participants who discontinue study treatment due to an AE are presented. | All randomized participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Up to ~1461 Days |
|
For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab + Olaparib | Participants received 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). | 372 | 529 | 179 | 526 | 495 | 526 |
| EG001 | Next-generation Hormonal Agent Monotherapy (NHA) | Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received 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. | 178 | 264 | 59 | 256 | 215 | 256 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infective spondylitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatitis Escherichia coli | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Radiation proctitis | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Postrenal failure | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | Clinicaltrialsdisclosure@msd.com |
| Apr 18, 2023 |
| Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C531550 | olaparib |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| C540278 | enzalutamide |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| RECIST Measurable: No |
|
| Enzalutamide only |
|
| Abiraterone and Enzalutamide |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received 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. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|