Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Olaparib+Pembrolizumab Participants receive olaparib 300 mg via oral tablet 2 times each day PLUS pembrolizumab 200 mg via intravenous infusion on Day 1 of each 21-day cycle. Participants may receive olaparib+pembrolizumab for up to approximately 2 years. |
Drug: Olaparib
Oral tablet
Other Names:
Biological: Pembrolizumab
Intravenous infusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 in Biomarker Subgroups [Up to ~3 years]
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR for all participants will be presented by biomarker subgroup.
Secondary Outcome Measures
- Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups [Up to ~3 years]
For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR for all participants who experience a CR or PR will be presented by biomarker subgroup.
- Progression-Free Survival (PFS) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups [Up to ~3 years]
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions is also considered PD. The PFS for all participants will be presented by biomarker subgroup.
- Overall Survival (OS) in Biomarker Subgroups [Up to ~3 years]
OS is the time from randomization to death due to any cause. The OS for all participants will be presented by biomarker subgroup.
- Number of Participants Who Experience an Adverse Event (AE) [Up to ~3 years]
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
- Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [Up to ~3 years]
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment will be presented.
- Objective Response Rate (ORR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations [Up to ~3 years]
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be presented by biomarker subpopulation.
- Duration of Response (DOR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations [Up to ~3 years]
For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR for all participants who experience a CR or PR will be presented by biomarker subpopulation.
- Progression-Free Survival (PFS) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations [Up to ~3 years]
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions is also considered PD. PFS will be presented by biomarker subpopulation.
- Overall Survival (OS) in Additional Biomarker Subpopulations [Up to ~3 years]
OS is the time from randomization to death due to any cause. OS will be presented by biomarker subpopulation.
- Number of Participants with Cancer Antigen-125 (CA-125) Level of ≥2 × Upper Limit of Normal (ULN) Among Participants with Ovarian Cancer [Up to ~3 years]
The number of participants who have ovarian cancer and have a CA-125 level ≥2 × upper limit of normal (ULN) at 2 different assessments that are measured at least 1 week apart will be presented.
- Number of Participants with Cancer Antigen-125 (CA-125) Level ≥2 × Nadir (Lowest) Value Among Participants with Ovarian Cancer Who Had Elevated CA-125 Levels ≥ULN at Baseline [Up to ~3 years]
The number of participants who have ovarian cancer with an elevated CA-125 level ≥ ULN at Baseline and have a CA-125 level ≥2 × the nadir (lowest) value at 2 different assessments that are measured at least 1 week apart will be presented.
- Number of Participants with a Change from Baseline in Prostate-Specific Antigen (PSA) Level of ≥50% Among Participants with Prostate Cancer [Up to ~3 years]
A PSA response is defined as a reduction in the PSA level of ≥50% from Baseline measured at 2 different times at least 3 weeks apart. The number of participants who have prostate cancer and have a change from Baseline in PSA level ≥50% will be presented.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except breast or ovarian cancers whose tumor has a germline or somatic BRCA mutation) that is not eligible for curative treatment and for which standard of care therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number of prior treatment regimens.
-
Has either centrally-confirmed known or suspected deleterious mutations in ≥1 of the specified 15 genes involved in HRR or centrally-confirmed HRD based on the Lynparza HRR-HRD assay.
-
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology and confirmed in real time by blinded independent central review (BICR). BICR must confirm the presence of radiologically measurable disease per RECIST 1.1 for the participant to be eligible for the study.
-
Has a life expectancy of ≥3 months.
-
Must have had CR or PR while on treatment with prior cisplatin or carboplatin, or had CR, PR, or stable disease (SD) while on treatment with prior oxaliplatin (either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor. Participant must also not have been refractory to prior platinum-containing therapy.
-
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of study treatment initiation.
-
Male participants must agree to use contraception during the treatment period and for ≥90 days (3 months) after the last dose of olaparib and refrain from donating sperm during this period.
-
Female participants must not be pregnant or breastfeeding, and ≥1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP who agrees to use contraception during the treatment period and for ≥120 days (3 months) after the last dose of pembrolizumab and 180 days (6 months) after the last dose of olaparib.
-
Has adequate organ function
Exclusion Criteria:
-
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
-
Has a history of non-infectious pneumonitis/interstitial lung disease that required treatment with steroids or currently has pneumonitis/interstitial lung disease.
-
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
-
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
-
Has an active infection requiring systemic therapy.
-
Has active tuberculosis (Bacillus tuberculosis [TB]).
-
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
-
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
-
Has received colony-stimulating factors (e.g. granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment.
-
Has a known history of human immunodeficiency virus (HIV) infection.
-
Has known active hepatitis B or hepatitis C.
-
Is unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption).
-
Has received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-programmed death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40 [Tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]).
-
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor.
-
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to administration of study treatment.
-
Must have recovered from all adverse events (AEs) due to previous therapies, excluding alopecia, to ≤Grade 1 or Baseline.
-
Has a known hypersensitivity to the study treatments and/or any of their excipients.
-
Is currently receiving either strong inhibitors of cytochrome P450 (CYP)3A4 (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate inhibitors of CYP3A4 (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks.
-
Is currently receiving either strong inducers of CYP3A4 (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate inducers of CYP3A4 (e.g. bosentan, efavirenz, modafinil) that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.
-
Has received previous allogenic bone-marrow transplant or double umbilical cord transplantation (dUCBT).
-
Has received a whole blood transfusion in the last 120 days prior to entry to the study.
-
Has received prior radiotherapy within 2 weeks of start of study treatment.
-
Is currently enrolled in and receiving study therapy, was enrolled in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks (28 days) of the first dose of study treatment.
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The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval by Fredericia [QTcF] prolongation >500 msec, electrolyte disturbances), or participant has congenital long QT syndrome.
-
Has either had major surgery within 2 weeks of starting study treatment or has not recovered from any effects of any major surgery.
-
Has received a live vaccine within 30 days prior to the first dose of study treatment.
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Has had an allogenic tissue/solid tumor organ transplant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Kirklin Clinic ( Site 0086) | Birmingham | Alabama | United States | 35233 |
| 2 | Banner MD Anderson Cancer Center ( Site 0049) | Gilbert | Arizona | United States | 85234 |
| 3 | UC Davis Comprehensive Cancer Center ( Site 0039) | Sacramento | California | United States | 95817 |
| 4 | San Francisco Oncology Associates ( Site 0085) | San Francisco | California | United States | 94115 |
| 5 | University of California San Francisco ( Site 0015) | San Francisco | California | United States | 94158 |
| 6 | Banner MD Anderson Cancer Center ( Site 0092) | Greeley | Colorado | United States | 80631 |
| 7 | University of Florida ( Site 0078) | Gainesville | Florida | United States | 32608 |
| 8 | Winship Cancer Institute of Emory University ( Site 0057) | Atlanta | Georgia | United States | 30322 |
| 9 | Northeast Georgia Medical Center ( Site 0026) | Gainesville | Georgia | United States | 30501 |
| 10 | Northwest Georgia Oncology Centers PC ( Site 0047) | Marietta | Georgia | United States | 30060 |
| 11 | Norton Cancer Institute - St. Matthews ( Site 0024) | Louisville | Kentucky | United States | 40207 |
| 12 | Atlantic Health System ( Site 0046) | Summit | New Jersey | United States | 07901 |
| 13 | New York Cancer and Blood Specialists-Research Department ( Site 0080) | Port Jefferson Station | New York | United States | 11776 |
| 14 | University Hospitals Cleveland Medical Center ( Site 0016) | Cleveland | Ohio | United States | 44106 |
| 15 | The University of Oklahoma Health Sciences Center ( Site 0050) | Oklahoma City | Oklahoma | United States | 73104 |
| 16 | Parkland Health & Hospital System ( Site 0091) | Dallas | Texas | United States | 75235 |
| 17 | University of Texas, Southwestern Medical Center ( Site 0004) | Dallas | Texas | United States | 75390 |
| 18 | University of Texas-MD Anderson Cancer Center ( Site 0087) | Houston | Texas | United States | 77030 |
| 19 | Utah Cancer Specialists ( Site 0038) | West Valley City | Utah | United States | 84119 |
| 20 | Inova Schar Cancer Institute ( Site 0008) | Fairfax | Virginia | United States | 22031 |
| 21 | Northwest Medical Specialties, PLLC ( Site 0007) | Tacoma | Washington | United States | 98405 |
| 22 | Fundacion CIDEA ( Site 2704) | Ciudad de Buenos Aires | Caba | Argentina | C1121ABE |
| 23 | Hospital Britanico de Buenos Aires ( Site 2705) | Ciudad de Buenos Aires | Caba | Argentina | C1280AEB |
| 24 | Centro Medico Dra De Salvo ( Site 2702) | Buenos Aires | Argentina | C1426ANZ | |
| 25 | CEMIC ( Site 2701) | Buenos Aires | Argentina | C1431FWO | |
| 26 | Centro Oncologico Riojano Integral ( Site 2703) | La Rioja | Argentina | F5300COE | |
| 27 | Blacktown Hospital ( Site 2202) | Blacktown | New South Wales | Australia | 2148 |
| 28 | Tasman Oncology Research Pty Ltd ( Site 2203) | Southport | Queensland | Australia | 4215 |
| 29 | Monash Health-Monash Medical Centre ( Site 2205) | Clayton | Victoria | Australia | 3168 |
| 30 | Linear Clinical Research Ltd ( Site 2206) | Nedlands | Western Australia | Australia | 6009 |
| 31 | BC Cancer-Vancouver Center ( Site 0203) | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 32 | Moncton Hospital - Horizon Health Network ( Site 0206) | Moncton | New Brunswick | Canada | E1C 6Z8 |
| 33 | Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201) | Montreal | Quebec | Canada | H2X 1R9 |
| 34 | Clínica Vida Fundación - Sede Poblado ( Site 2902) | Medellin | Antioquia | Colombia | 050030 |
| 35 | Clinica de la Costa Ltda. ( Site 2900) | Barranquilla | Atlantico | Colombia | 080020 |
| 36 | Fundacion Cardiovascular de Colombia ( Site 2907) | Piedecuesta | Santander | Colombia | 681017 |
| 37 | Hemato Oncologos S.A. ( Site 2910) | Cali | Valle Del Cauca | Colombia | 76001 |
| 38 | Fundacion Valle del Lili ( Site 2909) | Cali | Valle Del Cauca | Colombia | 760032 |
| 39 | CHU Jean Minjoz ( Site 0606) | Besancon | Doubs | France | 25030 |
| 40 | Institut du Cancer de Montpellier ( Site 0610) | Montpellier | Herault | France | 34298 |
| 41 | Centre Henri Becquerel ( Site 0607) | Rouen | Seine-Maritime | France | 76038 |
| 42 | Institut Gustave Roussy ( Site 0602) | Villejuif | Val-de-Marne | France | 94800 |
| 43 | CHD Vendee ( Site 0604) | La Roche sur Yon | Vendee | France | 85925 |
| 44 | Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906) | Muenchen | Bayern | Germany | 81377 |
| 45 | Universitaetsklinik Koeln ( Site 0903) | Koeln | Nordrhein-Westfalen | Germany | 50937 |
| 46 | Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902) | Berlin | Germany | 12203 | |
| 47 | Oncologika S.A. ( Site 3003) | Guatemala | Guatemala | 01010 | |
| 48 | Grupo Angeles SA ( Site 3004) | Guatemala | Guatemala | 01015 | |
| 49 | Sanatorio Nuestra Senora del Pilar ( Site 3006) | Guatemala | Guatemala | 01015 | |
| 50 | Medi-K Cayala ( Site 3005) | Guatemala | Guatemala | 01016 | |
| 51 | Centro Medico Integral De Cancerología (CEMIC) ( Site 3002) | Quetzaltenango | Guatemala | 09002 | |
| 52 | Rambam Health Care Campus-Oncology Division ( Site 0801) | Haifa | Israel | 3109601 | |
| 53 | Hadassah Ein Kerem Medical Center ( Site 0802) | Jerusalem | Israel | 9112001 | |
| 54 | Meir Medical Center ( Site 0804) | Kfar Saba | Israel | 4428164 | |
| 55 | Rabin Medical Center ( Site 0806) | Petah Tikva | Israel | 4941492 | |
| 56 | Chaim Sheba Medical Center ( Site 0800) | Ramat Gan | Israel | 5262000 | |
| 57 | Sourasky Medical Center ( Site 0805) | Tel Aviv | Israel | 6423906 | |
| 58 | Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703) | Modena | Emilia-Romagna | Italy | 41124 |
| 59 | ASST Grande Ospedale Metropolitano Niguarda ( Site 0700) | Milano | Italy | 20162 | |
| 60 | Istituto Nazionale Tumori Fondazione Pascale ( Site 0705) | Napoli | Italy | 80131 | |
| 61 | Azienda Ospedaliera Universitaria Senese ( Site 0704) | Siena | Italy | 53100 | |
| 62 | Aichi Cancer Center Hospital ( Site 2504) | Nagoya | Aichi | Japan | 464-8681 |
| 63 | National Cancer Center Hospital East ( Site 2500) | Kashiwa | Chiba | Japan | 277-8577 |
| 64 | Hokkaido University Hospital ( Site 2502) | Sapporo | Hokkaido | Japan | 060-8648 |
| 65 | Kyushu University Hospital ( Site 2506) | Fukuoka | Japan | 812-8582 | |
| 66 | Okayama University Hospital ( Site 2505) | Okayama | Japan | 700-8558 | |
| 67 | National Cancer Center Hospital ( Site 2501) | Tokyo | Japan | 104-0045 | |
| 68 | Japanese Foundation for Cancer Research ( Site 2503) | Tokyo | Japan | 135-8550 | |
| 69 | Seoul National University Bundang Hospital ( Site 2403) | Seongnam-si | Kyonggi-do | Korea, Republic of | 13605 |
| 70 | Seoul National University Hospital ( Site 2402) | Seoul | Korea, Republic of | 03080 | |
| 71 | Severance Hospital Yonsei University Health System ( Site 2400) | Seoul | Korea, Republic of | 03722 | |
| 72 | Samsung Medical Center ( Site 2401) | Seoul | Korea, Republic of | 06351 | |
| 73 | Daugavpils Regional Hospital ( Site 2104) | Daugavpils | Latvia | 5417 | |
| 74 | Liepaja Regional Hospital ( Site 2101) | Liepaja | Latvia | 3414 | |
| 75 | Riga East Clinical University Hospital ( Site 2103) | Riga | Latvia | 1079 | |
| 76 | P. Stradina Clinical University Hospital ( Site 2102) | Riga | Latvia | LV-1002 | |
| 77 | Fundacion Rodolfo Padilla Padilla A.C. ( Site 3102) | Leon | Guanajuato | Mexico | 37000 |
| 78 | Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108) | Monterrey | Nuevo Leon | Mexico | 64460 |
| 79 | Centro Medico Zambrano Hellion ( Site 3105) | San Pedro Garza Garcia | Nuevo Leon | Mexico | 66278 |
| 80 | Cuidados Oncologicos ( Site 3104) | Santiago De Quetaro | Queretaro | Mexico | 76000 |
| 81 | Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101) | Madero | Tamaulipas | Mexico | 89440 |
| 82 | CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103) | Ciudad de Mexico | Mexico | 06100 | |
| 83 | Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107) | Puebla | Mexico | 72530 | |
| 84 | Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206) | Arequipa | Ariqipa | Peru | 04001 |
| 85 | Hospital Nacional Daniel Alcides Carrion ( Site 3207) | Bellavista | Qallaw | Peru | 07021 |
| 86 | Hospital Nacional Adolfo Guevara Velasco ( Site 3205) | Cuzco | Qusqu | Peru | 08003 |
| 87 | Oncosalud ( Site 3200) | Lima | Peru | 15036 | |
| 88 | Instituto Nacional de Enfermedades Neoplasicas ( Site 3201) | Lima | Peru | 15038 | |
| 89 | Hospital Nacional Arzobispo Loayza ( Site 3208) | Lima | Peru | 15082 | |
| 90 | Clinica San Gabriel ( Site 3202) | Lima | Peru | 15088 | |
| 91 | Hospital Nacional Cayetano Heredia ( Site 3203) | Lima | Peru | 15102 | |
| 92 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie | Poland | 02-781 |
| 93 | Uniwersyteckie Centrum Kliniczne ( Site 1809) | Gdansk | Pomorskie | Poland | 80-214 |
| 94 | Hematology and Oncology Institute ( Site 0504) | Manati | Puerto Rico | 00674 | |
| 95 | Ad-Vance Medical Research LLC ( Site 0505) | Ponce | Puerto Rico | 00717 | |
| 96 | Pan American Center for Oncology Trials LLC ( Site 0501) | Rio Piedras | Puerto Rico | 00935 | |
| 97 | FDI Clinical Research ( Site 0500) | San Juan | Puerto Rico | 00927 | |
| 98 | Spitalul Judetean de Urgenta Alba Iulia ( Site 1107) | Alba Iulia | Alba | Romania | 510007 |
| 99 | Medisprof ( Site 1102) | Cluj Napoca | Cluj | Romania | 400641 |
| 100 | Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101) | Cluj-Napoca | Cluj | Romania | 400015 |
| 101 | S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103) | Craiova | Dolj | Romania | 200347 |
| 102 | Policlinica Oncomed SRL ( Site 1104) | Timisoara | Timis | Romania | 300239 |
| 103 | Universitas Annex National Hospital ( Site 1902) | Bloemfontein | Free State | South Africa | 9301 |
| 104 | Wits Clinical Research ( Site 1906) | Parktown-Johannesburg | Gauteng | South Africa | 2193 |
| 105 | Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900) | Pretoria | Gauteng | South Africa | 0181 |
| 106 | Vaal Triangle Oncology Centre ( Site 1905) | Vereeniging | Gauteng | South Africa | 1930 |
| 107 | The Oncology Centre ( Site 1904) | Durban | Kwazulu-Natal | South Africa | 4091 |
| 108 | Cancercare Rondebosch Oncology ( Site 1901) | Rondebosch | Western Cape | South Africa | 7700 |
| 109 | Hospital Quiron de Madrid ( Site 1301) | Pozuelo de Alarcon | Madrid | Spain | 28223 |
| 110 | Hospital Clinic i Provincial ( Site 1302) | Barcelona | Spain | 08036 | |
| 111 | Hospital General Universitario Gregorio Maranon ( Site 1300) | Madrid | Spain | 28007 | |
| 112 | Skanes Universitetssjukhus Lund. ( Site 2001) | Lund | Skane Lan | Sweden | 221 85 |
| 113 | Karolinska Universitetssjukhuset Solna ( Site 2000) | Solna | Stockholms Lan | Sweden | 171 76 |
| 114 | Akademiska Sjukhuset ( Site 2002) | Uppsala | Uppsala Lan | Sweden | 751 85 |
| 115 | Baskent University Adana Training Hospital ( Site 1509) | Adana | Turkey | 01250 | |
| 116 | Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502) | Ankara | Turkey | 06100 | |
| 117 | Gazi Universitesi Tip Fakultesi ( Site 1507) | Ankara | Turkey | 06500 | |
| 118 | Ankara Sehir Hastanesi ( Site 1508) | Ankara | Turkey | 06800 | |
| 119 | Akdeniz Universitesi Tıp Fakultesi ( Site 1503) | Antalya | Turkey | 07070 | |
| 120 | Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500) | Edirne | Turkey | 22030 | |
| 121 | Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504) | Istanbul | Turkey | 34098 | |
| 122 | Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505) | Istanbul | Turkey | 34722 | |
| 123 | Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501) | Izmir | Turkey | 35040 | |
| 124 | Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510) | Konya | Turkey | 42080 | |
| 125 | Inonu Universitesi Medical Fakultesi ( Site 1506) | Malatya | Turkey | 44280 | |
| 126 | Cherkasy Regional Oncology Dispensary ( Site 1702) | Cherkasy | Cherkaska Oblast | Ukraine | 18009 |
| 127 | Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700) | Dnipro | Dnipropetrovska Oblast | Ukraine | 49102 |
| 128 | Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient ( | Ivano-Frankivsk | Ivano-Frankivska Oblast | Ukraine | 1932 |
| 129 | Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704) | Kharkiv | Kharkivska Oblast | Ukraine | 61070 |
| 130 | Khmelnitskiy Regional Onkology Dispensary ( Site 1705) | Khmelnitskiy | Khmelnytska Oblast | Ukraine | 29009 |
| 131 | Kirovograd Regional oncology Dispensary ( Site 1716) | Kropyvnytsky | Kirovohradska Oblast | Ukraine | 25011 |
| 132 | Medical Centre Consilium Medical ( Site 1712) | Kyiv | Kyivska Oblast | Ukraine | 04050 |
| 133 | Podillya Regional Center of Oncology ( Site 1708) | Vinnytsia | Vinnytska Oblast | Ukraine | 21029 |
| 134 | Medical center of the Limited Liability Company Yulis ( Site 1714) | Zaporizhzhia | Zaporizka Oblast | Ukraine | 69035 |
| 135 | Zhytomyr Regional Oncology Center ( Site 1710) | Zhytomyr | Zhytomyrska Oblast | Ukraine | 10002 |
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:
Publications
None provided.- 7339-007
- MK-7339-007
- KEYLYNK-007
- jRCT2011200025
- 2019-001745-40