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)
- Conditions
- Solid Tumors
- Interventions
- Registration Number
- NCT04123366
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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 the last treatment with prior cisplatin or carboplatin, or if received only oxaliplatin had CR, PR, or stable disease (SD) while on the last 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 a highly sensitive pregnancy test within 24 hours for urine or within 72 hours for serum before the first dose of study intervention, and abstains from breastfeeding during the study intervention period and for at least 120 days after the last dose of the study intervention.
- Has adequate organ function
- 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.
- 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.
- 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.
- Has had an allogenic tissue/solid tumor organ transplant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Olaparib+Pembrolizumab Olaparib 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. Olaparib+Pembrolizumab 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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 ≥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.
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.
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.
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 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.
Trial Locations
- Locations (135)
Monash Medical Centre ( Site 2205)
🇦🇺Clayton, Victoria, Australia
CEMIC ( Site 2701)
🇦🇷Buenos Aires, Argentina
Universitaetsklinik Koeln ( Site 0903)
🇩🇪Koeln, Nordrhein-Westfalen, Germany
Hadassah Ein Kerem Medical Center ( Site 0802)
🇮🇱Jerusalem, Israel
Rabin Medical Center ( Site 0806)
🇮🇱Petah Tikva, Israel
Aichi Cancer Center Hospital ( Site 2504)
🇯🇵Nagoya, Aichi, Japan
Japanese Foundation for Cancer Research ( Site 2503)
🇯🇵Tokyo, Japan
Kyushu University Hospital ( Site 2506)
🇯🇵Fukuoka, Japan
Centro Medico Zambrano Hellion ( Site 3105)
🇲🇽San Pedro Garza Garcia, Nuevo Leon, Mexico
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)
🇮🇹Modena, Emilia-Romagna, Italy
Medi-K Cayala ( Site 3005)
🇬🇹Guatemala, Guatemala
Sourasky Medical Center ( Site 0805)
🇮🇱Tel Aviv, Israel
Akdeniz Universitesi Tıp Fakultesi ( Site 1503)
🇹🇷Antalya, Turkey
Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)
🇹🇷Izmir, Turkey
Winship Cancer Institute of Emory University ( Site 0057)
🇺🇸Atlanta, Georgia, United States
Northwest Georgia Oncology Centers PC ( Site 0047)
🇺🇸Marietta, Georgia, United States
Northeast Georgia Medical Center ( Site 0026)
🇺🇸Gainesville, Georgia, United States
Parkland Health & Hospital System ( Site 0091)
🇺🇸Dallas, Texas, United States
Zhytomyr Regional Oncology Center ( Site 1710)
🇺🇦Zhytomyr, Zhytomyrska Oblast, Ukraine
The Oncology Centre ( Site 1904)
🇿🇦Durban, Kwazulu-Natal, South Africa
Banner MD Anderson Cancer Center ( Site 0092)
🇺🇸Greeley, Colorado, United States
New York Cancer and Blood Specialists-Research Department ( Site 0080)
🇺🇸Port Jefferson Station, New York, United States
Linear Clinical Research Ltd ( Site 2206)
🇦🇺Nedlands, Western Australia, Australia
University Hospitals Cleveland Medical Center ( Site 0016)
🇺🇸Cleveland, Ohio, United States
Blacktown Hospital ( Site 2202)
🇦🇺Blacktown, New South Wales, Australia
Centro Oncologico Riojano Integral ( Site 2703)
🇦🇷La Rioja, Argentina
Northwest Medical Specialties, PLLC ( Site 0007)
🇺🇸Tacoma, Washington, United States
Inova Schar Cancer Institute ( Site 0008)
🇺🇸Fairfax, Virginia, United States
Centro Medico Dra De Salvo ( Site 2702)
🇦🇷Buenos Aires, Argentina
Hemato Oncologos S.A. ( Site 2910)
🇨🇴Cali, Valle Del Cauca, Colombia
CHD Vendee ( Site 0604)
🇫🇷La Roche sur Yon, Vendee, France
Oncologika S.A. ( Site 3003)
🇬🇹Guatemala, Guatemala
Grupo Angeles SA ( Site 3004)
🇬🇹Guatemala, Guatemala
Meir Medical Center ( Site 0804)
🇮🇱Kfar Saba, Israel
Azienda Ospedaliera Universitaria Senese ( Site 0704)
🇮🇹Siena, Italy
Oncosalud ( Site 3200)
🇵🇪Lima, Peru
Hospital Nacional Arzobispo Loayza ( Site 3208)
🇵🇪Lima, Peru
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
🇵🇱Warszawa, Mazowieckie, Poland
Ad-Vance Medical Research LLC ( Site 0505)
🇵🇷Ponce, Puerto Rico
Hospital Quiron de Madrid ( Site 1301)
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Akademiska Sjukhuset ( Site 2002)
🇸🇪Uppsala, Uppsala Lan, Sweden
Hospital General Universitario Gregorio Maranon ( Site 1300)
🇪🇸Madrid, Spain
Wits Clinical Research ( Site 1906)
🇿🇦Parktown-Johannesburg, Gauteng, South Africa
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)
🇵🇪Arequipa, Ariqipa, Peru
Hospital Nacional Adolfo Guevara Velasco ( Site 3205)
🇵🇪Cuzco, Qusqu, Peru
Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)
🇿🇦Pretoria, Gauteng, South Africa
Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)
🇵🇪Lima, Peru
Hematology and Oncology Institute ( Site 0504)
🇵🇷Manati, Puerto Rico
Medisprof ( Site 1102)
🇷🇴Cluj Napoca, Cluj, Romania
Hospital Clinic i Provincial ( Site 1302)
🇪🇸Barcelona, Spain
Cancercare Rondebosch Oncology ( Site 1901)
🇿🇦Rondebosch, Western Cape, South Africa
Vaal Triangle Oncology Centre ( Site 1905)
🇿🇦Vereeniging, Gauteng, South Africa
Universitas Annex National Hospital ( Site 1902)
🇿🇦Bloemfontein, Free State, South Africa
The University of Oklahoma Health Sciences Center ( Site 0050)
🇺🇸Oklahoma City, Oklahoma, United States
The Kirklin Clinic ( Site 0086)
🇺🇸Birmingham, Alabama, United States
UC Davis Comprehensive Cancer Center ( Site 0039)
🇺🇸Sacramento, California, United States
San Francisco Oncology Associates ( Site 0085)
🇺🇸San Francisco, California, United States
University of California San Francisco ( Site 0015)
🇺🇸San Francisco, California, United States
Norton Cancer Institute - St. Matthews ( Site 0024)
🇺🇸Louisville, Kentucky, United States
University of Texas-MD Anderson Cancer Center ( Site 0087)
🇺🇸Houston, Texas, United States
ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)
🇮🇹Milano, Italy
University of Texas, Southwestern Medical Center ( Site 0004)
🇺🇸Dallas, Texas, United States
Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)
🇩🇪Muenchen, Bayern, Germany
Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)
🇮🇹Napoli, Italy
Preparaciones Oncologicas ( Site 3102)
🇲🇽León, Guanajuato, Mexico
Okayama University Hospital ( Site 2505)
🇯🇵Okayama, Japan
Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)
🇲🇽Monterrey, Nuevo Leon, Mexico
Uniwersyteckie Centrum Kliniczne ( Site 1809)
🇵🇱Gdansk, Pomorskie, Poland
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)
🇲🇽Madero, Tamaulipas, Mexico
Karolinska Universitetssjukhuset Solna ( Site 2000)
🇸🇪Solna, Stockholms Lan, Sweden
Skanes Universitetssjukhus Lund. ( Site 2001)
🇸🇪Lund, Skane Lan, Sweden
Gazi Universitesi Tip Fakultesi ( Site 1507)
🇹🇷Ankara, Turkey
Inonu Universitesi Medical Fakultesi ( Site 1506)
🇹🇷Malatya, Turkey
Cherkasy Regional Oncology Dispensary ( Site 1702)
🇺🇦Cherkasy, Cherkaska Oblast, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Samsung Medical Center ( Site 2401)
🇰🇷Seoul, Korea, Republic of
Ankara Sehir Hastanesi ( Site 1508)
🇹🇷Ankara, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)
🇹🇷Ankara, Turkey
Hospital Britanico de Buenos Aires ( Site 2705)
🇦🇷Ciudad de Buenos Aires, Caba, Argentina
Chaim Sheba Medical Center ( Site 0800)
🇮🇱Ramat Gan, Israel
National Cancer Center Hospital ( Site 2501)
🇯🇵Tokyo, Japan
Seoul National University Bundang Hospital ( Site 2403)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
Riga East Clinical University Hospital ( Site 2103)
🇱🇻Riga, Latvia
Hospital H+ Queretaro ( Site 3104)
🇲🇽Santiago de Queretaro, Queretaro, Mexico
Severance Hospital Yonsei University Health System ( Site 2400)
🇰🇷Seoul, Korea, Republic of
Banner MD Anderson Cancer Center ( Site 0049)
🇺🇸Gilbert, Arizona, United States
Moncton Hospital - Horizon Health Network ( Site 0206)
🇨🇦Moncton, New Brunswick, Canada
University of Florida ( Site 0078)
🇺🇸Gainesville, Florida, United States
Atlantic Health System ( Site 0046)
🇺🇸Summit, New Jersey, United States
Tasman Oncology Research Pty Ltd ( Site 2203)
🇦🇺Southport, Queensland, Australia
Fundacion Cardiovascular de Colombia ( Site 2907)
🇨🇴Piedecuesta, Santander, Colombia
Fundacion CIDEA ( Site 2704)
🇦🇷Ciudad de Buenos Aires, Caba, Argentina
Utah Cancer Specialists ( Site 0038)
🇺🇸West Valley City, Utah, United States
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)
🇨🇦Montreal, Quebec, Canada
Fundación Colombiana de Cancerología Clínica Vida ( Site 2902)
🇨🇴Medellin, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 2900)
🇨🇴Barranquilla, Atlantico, Colombia
CHU Jean Minjoz ( Site 0606)
🇫🇷Besancon, Doubs, France
Institut du Cancer de Montpellier ( Site 0610)
🇫🇷Montpellier, Herault, France
Centre Henri Becquerel ( Site 0607)
🇫🇷Rouen, Seine-Maritime, France
Institut Gustave Roussy ( Site 0602)
🇫🇷Villejuif, Val-de-Marne, France
Sanatorio Nuestra Senora del Pilar ( Site 3006)
🇬🇹Guatemala, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)
🇬🇹Quetzaltenango, Guatemala
Rambam Health Care Campus-Oncology Division ( Site 0801)
🇮🇱Haifa, Israel
National Cancer Center Hospital East ( Site 2500)
🇯🇵Kashiwa, Chiba, Japan
Hokkaido University Hospital ( Site 2502)
🇯🇵Sapporo, Hokkaido, Japan
Daugavpils Regional Hospital ( Site 2104)
🇱🇻Daugavpils, Latvia
Liepaja Regional Hospital ( Site 2101)
🇱🇻Liepaja, Latvia
P. Stradina Clinical University Hospital ( Site 2102)
🇱🇻Riga, Latvia
Seoul National University Hospital ( Site 2402)
🇰🇷Seoul, Korea, Republic of
BC Cancer-Vancouver Center ( Site 0203)
🇨🇦Vancouver, British Columbia, Canada
Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)
🇩🇪Berlin, Germany
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)
🇲🇽Ciudad de Mexico, Mexico
Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)
🇲🇽Puebla, Mexico
Hospital Nacional Daniel Alcides Carrion ( Site 3207)
🇵🇪Bellavista, Qallaw, Peru
Clinica San Gabriel ( Site 3202)
🇵🇪Lima, Peru
Hospital Nacional Cayetano Heredia ( Site 3203)
🇵🇪Lima, Peru
Pan American Center for Oncology Trials LLC ( Site 0501)
🇵🇷Rio Piedras, Puerto Rico
FDI Clinical Research ( Site 0500)
🇵🇷San Juan, Puerto Rico
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)
🇷🇴Cluj-Napoca, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
🇷🇴Craiova, Dolj, Romania
Policlinica Oncomed SRL ( Site 1104)
🇷🇴Timisoara, Timis, Romania
Baskent University Adana Training Hospital ( Site 1509)
🇹🇷Adana, Turkey
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)
🇹🇷Edirne, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)
🇹🇷Istanbul, Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505)
🇹🇷Istanbul, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)
🇹🇷Konya, Turkey
Khmelnitskiy Regional Onkology Dispensary ( Site 1705)
🇺🇦Khmelnitskiy, Khmelnytska Oblast, Ukraine
Medical Centre Consilium Medical ( Site 1712)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Medical center of the Limited Liability Company Yulis ( Site 1714)
🇺🇦Zaporizhzhia, Zaporizka Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Kirovograd Regional oncology Dispensary ( Site 1716)
🇺🇦Kropyvnytsky, Kirovohradska Oblast, Ukraine
Podillya Regional Center of Oncology ( Site 1708)
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
Fundacion Valle del Lili ( Site 2909)
🇨🇴Cali, Valle Del Cauca, Colombia
Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)
🇷🇴Alba Iulia, Alba, Romania