Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Trial Title: Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

NCT ID: NCT04624204

Condition: Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Pembrolizumab
Etoposide
Olaparib

Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Pembrolizumab
Olaparib

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Biological
Intervention name: Pembrolizumab 200 mg
Description: Pembrolizumab 200 mg Q3W
Arm group label: Group A - Pembrolizumab 200 mg
Arm group label: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

Other name: MK-3475

Other name: KEYTRUDA®

Intervention type: Biological
Intervention name: Pembrolizumab 400 mg
Description: Pembrolizumab 400 mg Q6W
Arm group label: Group A - Pembrolizumab 200 mg
Arm group label: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

Other name: MK-3475

Other name: KEYTRUDA®

Intervention type: Drug
Intervention name: Pembrolizumab placebo (saline)
Description: Pembrolizumab placebo (saline) Q3W
Arm group label: Group C (Pembrolizumab and Olaparib Matching Placebos)

Intervention type: Drug
Intervention name: Pembrolizumab placebo (saline)
Description: Pembrolizumab placebo (saline) Q6W
Arm group label: Group C (Pembrolizumab and Olaparib Matching Placebos)

Intervention type: Drug
Intervention name: Olaparib 300 mg BID
Description: Olaparib 300 mg twice daily (BID)
Arm group label: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

Other name: MK-7339

Other name: LYNPARZA®

Intervention type: Drug
Intervention name: Olaparib matching placebo
Description: Olaparib matching placebo BID
Arm group label: Group A - Pembrolizumab 200 mg
Arm group label: Group C (Pembrolizumab and Olaparib Matching Placebos)

Intervention type: Drug
Intervention name: Etoposide 100 mg/m^2
Description: Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3
Arm group label: Group A - Pembrolizumab 200 mg
Arm group label: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
Arm group label: Group C (Pembrolizumab and Olaparib Matching Placebos)

Intervention type: Drug
Intervention name: Platinum, investigator's choice
Description: Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle
Arm group label: Group A - Pembrolizumab 200 mg
Arm group label: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
Arm group label: Group C (Pembrolizumab and Olaparib Matching Placebos)

Intervention type: Radiation
Intervention name: Standard Thoracic Radiotherapy
Description: Standard Thoracic Radiotherapy
Arm group label: Group A - Pembrolizumab 200 mg
Arm group label: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
Arm group label: Group C (Pembrolizumab and Olaparib Matching Placebos)

Intervention type: Radiation
Intervention name: Prophylactic Cranial Irradiation (PCI)
Description: PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Arm group label: Group A - Pembrolizumab 200 mg
Arm group label: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
Arm group label: Group C (Pembrolizumab and Olaparib Matching Placebos)

Summary: Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC). Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible. 2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses. 3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans 4. Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) 5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC. 6. Is not expected to require tumor resection during the course of the study. 7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable. 8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention. 9. Has a life expectancy of at least 6 months. 10. Has adequate organ function. 11. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention. 12. Male and female participants who are at least 18 years of age at the time of signing the information consent. 13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention. 14. Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention: - Pembrolizumab: 120 days - Olaparib: 7 days Exclusion Criteria: 1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML). 2. Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor 3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor. 4. Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access). 5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 8. Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients. 9. Has an active autoimmune disease that has required systemic treatment in past 2 years 10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids 11. Has an active infection requiring systemic therapy. 12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ironwood Cancer & Research Centers ( Site 0007)

Address:
City: Chandler
Zip: 85224
Country: United States

Facility:
Name: Loma Linda University Cancer Center ( Site 0011)

Address:
City: Loma Linda
Zip: 92350
Country: United States

Facility:
Name: Georgetown University ( Site 0017)

Address:
City: Washington
Zip: 20007
Country: United States

Facility:
Name: Moffitt Cancer Center ( Site 0137)

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: University of Chicago Medical Center ( Site 0136)

Address:
City: Chicago
Zip: 60637
Country: United States

Facility:
Name: Fort Wayne Medical Oncology and Hematology ( Site 0034)

Address:
City: Fort Wayne
Zip: 46804
Country: United States

Facility:
Name: University of Kentucky Chandler Medical Center ( Site 0138)

Address:
City: Lexington
Zip: 40536
Country: United States

Facility:
Name: Overton Brooks VAMC ( Site 0041)

Address:
City: Shreveport
Zip: 71101
Country: United States

Facility:
Name: Harry & Jeanette Weinberg Cancer Institute ( Site 0045)

Address:
City: Baltimore
Zip: 21237
Country: United States

Facility:
Name: VA Ann Arbor Healthcare System ( Site 0050)

Address:
City: Ann Arbor
Zip: 48105
Country: United States

Facility:
Name: St. Vincent Healthcare Frontier Cancer Center ( Site 0056)

Address:
City: Billings
Zip: 59102
Country: United States

Facility:
Name: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)

Address:
City: Omaha
Zip: 68130
Country: United States

Facility:
Name: Memorial Sloan Kettering - Basking Ridge ( Site 0133)

Address:
City: Basking Ridge
Zip: 07920
Country: United States

Facility:
Name: John Theurer Cancer Center ( Site 0064)

Address:
City: Hackensack
Zip: 07601
Country: United States

Facility:
Name: Memorial Sloan Kettering - Monmouth ( Site 0135)

Address:
City: Middletown
Zip: 07748
Country: United States

Facility:
Name: Memorial Sloan Kettering - Bergen ( Site 0130)

Address:
City: Montvale
Zip: 07645
Country: United States

Facility:
Name: Rutgers Cancer Institute of New Jersey ( Site 0123)

Address:
City: New Brunswick
Zip: 08903
Country: United States

Facility:
Name: Memorial Sloan Kettering- Commack ( Site 0132)

Address:
City: Commack
Zip: 11725
Country: United States

Facility:
Name: Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)

Address:
City: Harrison
Zip: 10604
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center ( Site 0069)

Address:
City: New York
Zip: 10021
Country: United States

Facility:
Name: Memorial Sloan Kettering - Nassau ( Site 0131)

Address:
City: Uniondale
Zip: 11553
Country: United States

Facility:
Name: Fairview Hospital-Moll Cancer Center ( Site 0141)

Address:
City: Cleveland
Zip: 44111
Country: United States

Facility:
Name: Cleveland Clinic Main ( Site 0139)

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)

Address:
City: Mayfield Heights
Zip: 44124
Country: United States

Facility:
Name: Penn State Hershey Cancer Institute ( Site 0081)

Address:
City: Hershey
Zip: 17033
Country: United States

Facility:
Name: Saint Francis Cancer Center ( Site 0087)

Address:
City: Greenville
Zip: 29607
Country: United States

Facility:
Name: The University of Tennessee Medical Center ( Site 0116)

Address:
City: Knoxville
Zip: 37920
Country: United States

Facility:
Name: Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)

Address:
City: Dallas
Zip: 75231
Country: United States

Facility:
Name: Texas Oncology - Dallas (Sammons) ( Site 0093)

Address:
City: Dallas
Zip: 75246
Country: United States

Facility:
Name: MD Anderson Cancer Center ( Site 0100)

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Millennium Research & Clinical Development ( Site 0143)

Address:
City: Houston
Zip: 77090
Country: United States

Facility:
Name: Providence Regional Cancer Partnership ( Site 0106)

Address:
City: Everett
Zip: 98201
Country: United States

Facility:
Name: Medical Oncology Associates, PS ( Site 0142)

Address:
City: Spokane
Zip: 99208
Country: United States

Facility:
Name: Multicare Institute For Research And Innovation ( Site 0108)

Address:
City: Tacoma
Zip: 98405
Country: United States

Facility:
Name: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)

Address:
City: Yakima
Zip: 98902
Country: United States

Facility:
Name: Campbelltown Hospital ( Site 3002)

Address:
City: Campbelltown
Zip: 2560
Country: Australia

Facility:
Name: Nepean Hospital ( Site 3001)

Address:
City: Kingswood
Zip: 2747
Country: Australia

Facility:
Name: Calvary Mater Newcastle ( Site 3000)

Address:
City: Waratah
Zip: 2298
Country: Australia

Facility:
Name: Gold Coast University Hospital ( Site 3003)

Address:
City: Southport
Zip: 4215
Country: Australia

Facility:
Name: Frankston Hospital-Oncology and Haematology ( Site 3007)

Address:
City: Frankston
Zip: 3199
Country: Australia

Facility:
Name: Austin Health-Austin Hospital ( Site 3006)

Address:
City: Heidelberg
Zip: 3084
Country: Australia

Facility:
Name: Western Health-Sunshine Hospital ( Site 3004)

Address:
City: St Albans
Zip: 3021
Country: Australia

Facility:
Name: Saint-Luc UCL ( Site 1005)

Address:
City: Brussels
Zip: 1200
Country: Belgium

Facility:
Name: Grand Hopital de Charleroi ( Site 1003)

Address:
City: Charleroi
Zip: 6000
Country: Belgium

Facility:
Name: C.I.U. Hopital Ambroise Pare ( Site 1001)

Address:
City: Mons
Zip: 7000
Country: Belgium

Facility:
Name: CHU UCL Namur Site de Godinne ( Site 1004)

Address:
City: Yvoir
Zip: 5530
Country: Belgium

Facility:
Name: UZ Leuven ( Site 1002)

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: AZ Delta ( Site 1000)

Address:
City: Roeselare
Zip: 8800
Country: Belgium

Facility:
Name: MHAT "Uni Hospital" OOD ( Site 2507)

Address:
City: Panagyurishte
Zip: 4500
Country: Bulgaria

Facility:
Name: Cross Cancer Institute ( Site 0206)

Address:
City: Edmonton
Zip: T6G 1Z2
Country: Canada

Facility:
Name: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)

Address:
City: Hamilton
Zip: L8V 5C2
Country: Canada

Facility:
Name: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)

Address:
City: Montreal
Zip: H3T 1M5
Country: Canada

Facility:
Name: McGill University Health Centre ( Site 0210)

Address:
City: Montréal
Zip: H4A 3J1
Country: Canada

Facility:
Name: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)

Address:
City: Trois-Rivieres
Zip: G8Z 3R9
Country: Canada

Facility:
Name: Peking Union Medical College Hospital ( Site 3102)

Address:
City: Beijing
Zip: 100006
Country: China

Facility:
Name: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)

Address:
City: Beijing
Zip: 100021
Country: China

Facility:
Name: Beijing Cancer Hospital ( Site 3127)

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Chongqing Cancer Hospital ( Site 3135)

Address:
City: Chongqing
Zip: 400030
Country: China

Facility:
Name: Daping Hospital,Third Military Medical University ( Site 3136)

Address:
City: Chongqing
Zip: 400042
Country: China

Facility:
Name: Fujian Provincial Cancer Hospital ( Site 3126)

Address:
City: Fuzhou
Zip: 350014
Country: China

Facility:
Name: The First Affiliated Hospital of Xiamen University ( Site 3121)

Address:
City: Xiamen
Zip: 361003
Country: China

Facility:
Name: Peking University Shenzhen Hospital ( Site 3118)

Address:
City: Shenzhen
Zip: 518036
Country: China

Facility:
Name: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)

Address:
City: Shenzhen
Zip: 518116
Country: China

Facility:
Name: Henan Cancer Hospital ( Site 3105)

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Wuhan Union Hospital ( Site 3123)

Address:
City: Wuhan
Zip: 430022
Country: China

Facility:
Name: Tongji Medical College Huazhong University of Science and Technology ( Site 3138)

Address:
City: Wuhan
Zip: 430030
Country: China

Facility:
Name: Hubei Cancer Hospital ( Site 3120)

Address:
City: Wuhan
Zip: 430079
Country: China

Facility:
Name: Hunan Cancer Hospital ( Site 3133)

Address:
City: Changsha
Zip: 410006
Country: China

Facility:
Name: Xiangya Hospital of Central South University ( Site 3137)

Address:
City: Changsha
Zip: 410008
Country: China

Facility:
Name: Second Xiangya Hospital of Central-South University ( Site 3128)

Address:
City: Changsha
Zip: 410011
Country: China

Facility:
Name: Jiangsu Cancer Hospital ( Site 3139)

Address:
City: Nanjing
Zip: 210000
Country: China

Facility:
Name: The Second Affiliated Hospital of Nanchang University ( Site 3106)

Address:
City: Nanchang
Zip: 330006
Country: China

Facility:
Name: The First Hospital of Jilin University ( Site 3132)

Address:
City: Changchun
Zip: 130021
Country: China

Facility:
Name: Shandong Province Cancer Hospital ( Site 3100)

Address:
City: Jinan
Zip: 250117
Country: China

Facility:
Name: Shanghai Chest Hospital ( Site 3107)

Address:
City: Shangai
Zip: 200030
Country: China

Facility:
Name: Shanghai Pulmonary Hospital ( Site 3101)

Address:
City: Shanghai
Zip: 200443
Country: China

Facility:
Name: West China Hospital of Sichuan University ( Site 3114)

Address:
City: Chengdu
Zip: 510115
Country: China

Facility:
Name: Tianjin Medical University Cancer Institute & Hospital ( Site 3103)

Address:
City: Tianjin
Zip: 300060
Country: China

Facility:
Name: Hangzhou Cancer Hospital ( Site 3129)

Address:
City: Hanghzou
Zip: 310002
Country: China

Facility:
Name: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)

Address:
City: Hangzhou
Zip: 310003
Country: China

Facility:
Name: Zhejiang Cancer Hospital.... ( Site 3108)

Address:
City: Hangzhou
Zip: 310022
Country: China

Facility:
Name: SA Pohja-Eesti Regionaalhaigla ( Site 2201)

Address:
City: Tallinn
Zip: 13419
Country: Estonia

Facility:
Name: SA Tartu Ulikooli Kliinikum ( Site 2200)

Address:
City: Tartu
Zip: 50406
Country: Estonia

Facility:
Name: C.H. de Saint Quentin ( Site 1111)

Address:
City: Saint Quentin
Zip: 02321
Country: France

Facility:
Name: CHU de Bordeaux Hop St ANDRE ( Site 1115)

Address:
City: Bordeaux
Zip: 33075
Country: France

Facility:
Name: Clinique Clairval ( Site 1108)

Address:
City: Marseille
Zip: 13009
Country: France

Facility:
Name: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)

Address:
City: Paris
Zip: 75014
Country: France

Facility:
Name: CHU Grenoble -Hop Michallon ( Site 1102)

Address:
City: Grenoble
Zip: 38043
Country: France

Facility:
Name: Institut De Cancerologie De L Ouest ( Site 1110)

Address:
City: Saint Herblain
Zip: 44805
Country: France

Facility:
Name: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)

Address:
City: Angers
Zip: 49000
Country: France

Facility:
Name: Hopital Avicenne ( Site 1106)

Address:
City: Bobigny
Zip: 93000
Country: France

Facility:
Name: H.I.A. Sainte-Anne ( Site 1101)

Address:
City: Toulon
Zip: 83800
Country: France

Facility:
Name: Henry Dunant Hospital ( Site 1205)

Address:
City: Athens
Zip: 115 26
Country: Greece

Facility:
Name: Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)

Address:
City: Athens
Zip: 115 27
Country: Greece

Facility:
Name: University General Hospital of Herakleion ( Site 1202)

Address:
City: Heraklion
Zip: 711 10
Country: Greece

Facility:
Name: Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)

Address:
City: Thessaloniki
Zip: 54007
Country: Greece

Facility:
Name: University General Hospital of Larisa ( Site 1201)

Address:
City: Larissa
Zip: 411 10
Country: Greece

Facility:
Name: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)

Address:
City: Kecskemét
Zip: 6000
Country: Hungary

Facility:
Name: Petz Aladar Megyei Oktato Korhaz ( Site 1312)

Address:
City: Gyor
Zip: 9024
Country: Hungary

Facility:
Name: Reformatus Pulmonologiai Centrum ( Site 1304)

Address:
City: Torokbalint
Zip: 2045
Country: Hungary

Facility:
Name: Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Orszagos Onkologiai Intezet ( Site 1310)

Address:
City: Budapest
Zip: 1122
Country: Hungary

Facility:
Name: Uzsoki Utcai Korhaz ( Site 1303)

Address:
City: Budapest
Zip: 1145
Country: Hungary

Facility:
Name: Rambam Health Care Campus-Oncology Division ( Site 1401)

Address:
City: Haifa
Zip: 3109601
Country: Israel

Facility:
Name: Chaim Sheba Medical Center ( Site 1400)

Address:
City: Ramat Gan
Zip: 5262000
Country: Israel

Facility:
Name: A O U Policlinico di Modena ( Site 1503)

Address:
City: Modena
Zip: 41125
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Careggi ( Site 1509)

Address:
City: Florence
Zip: 50134
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 1513

Address:
City: Verona
Zip: 37126
Country: Italy

Facility:
Name: Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)

Address:
City: Brescia
Zip: 25123
Country: Italy

Facility:
Name: IRCCS Ospedale San Raffaele ( Site 1500)

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: Istituto Nazionale dei Tumori ( Site 1504)

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: Istituto Europeo di Oncologia ( Site 1501)

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: IRCCS Istituto Oncologico Veneto ( Site 1506)

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: Policlinico Universitario Agostino Gemelli ( Site 1505)

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: Aichi Cancer Center Hospital ( Site 4010)

Address:
City: Nagoya
Zip: 464-8681
Country: Japan

Facility:
Name: Kobe Minimally Invasive Cancer Center ( Site 4003)

Address:
City: Kobe
Zip: 650-0046
Country: Japan

Facility:
Name: Takarazuka City Hospital ( Site 4013)

Address:
City: Takarazuka
Zip: 665-0827
Country: Japan

Facility:
Name: Kanagawa Cancer Center ( Site 4001)

Address:
City: Yokohama
Zip: 241-8515
Country: Japan

Facility:
Name: Kansai Medical University Hospital ( Site 4009)

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Facility:
Name: Osaka Medical and Pharmaceutical University Hospital ( Site 4007)

Address:
City: Takatsuki
Zip: 5698686
Country: Japan

Facility:
Name: Shizuoka Cancer Center ( Site 4014)

Address:
City: Nagaizumi
Zip: 411-8777
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center ( Site 4000)

Address:
City: Fukuoka
Zip: 811-1395
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital ( Site 4004)

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Facility:
Name: Okayama University Hospital ( Site 4012)

Address:
City: Okayama
Zip: 700-8558
Country: Japan

Facility:
Name: Osaka International Cancer Institute ( Site 4005)

Address:
City: Osaka
Zip: 541-8567
Country: Japan

Facility:
Name: National Cancer Center Hospital ( Site 4015)

Address:
City: Tokyo
Zip: 104-0045
Country: Japan

Facility:
Name: Juntendo University Hospital ( Site 4008)

Address:
City: Tokyo
Zip: 113-0033
Country: Japan

Facility:
Name: Tokyo Metropolitan Komagome Hospital ( Site 4011)

Address:
City: Tokyo
Zip: 113-8677
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR ( Site 4006)

Address:
City: Tokyo
Zip: 135-8550
Country: Japan

Facility:
Name: Showa University Hospital ( Site 4002)

Address:
City: Tokyo
Zip: 142-8666
Country: Japan

Facility:
Name: National Cancer Center ( Site 3306)

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital ( Site 3301)

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea St. Vincent s Hospital ( Site 3303)

Address:
City: Suwon-si
Zip: 16247
Country: Korea, Republic of

Facility:
Name: Inje University Haeundae Paik Hospital ( Site 3307)

Address:
City: Busan
Zip: 48108
Country: Korea, Republic of

Facility:
Name: Asan Medical Center ( Site 3308)

Address:
City: Songpagu
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)

Address:
City: Daegu
Zip: 42601
Country: Korea, Republic of

Facility:
Name: Severance Hospital Yonsei University Health System ( Site 3304)

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center ( Site 3300)

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Nacionalinis Vezio Institutas ( Site 2300)

Address:
City: Vilnius
Zip: 08660
Country: Lithuania

Facility:
Name: LSMUL Kauno Klinikos ( Site 2301)

Address:
City: Kaunas
Zip: 50161
Country: Lithuania

Facility:
Name: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Facility:
Name: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)

Address:
City: Lisboa
Zip: 1099-023
Country: Portugal

Facility:
Name: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1704)

Address:
City: Lisboa
Zip: 1769-001
Country: Portugal

Facility:
Name: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)

Address:
City: Porto
Zip: 4200-072
Country: Portugal

Facility:
Name: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)

Address:
City: Cluj-Napoca
Zip: 400015
Country: Romania

Facility:
Name: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)

Address:
City: Florești
Zip: 407280
Country: Romania

Facility:
Name: Spitalul Municipal Ploiesti ( Site 2801)

Address:
City: Ploiesti
Zip: 100337
Country: Romania

Facility:
Name: Cabinet Medical Oncomed ( Site 2802)

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: S.C.Focus Lab Plus S.R.L ( Site 2804)

Address:
City: Bucuresti
Zip: 022548
Country: Romania

Facility:
Name: Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)

Address:
City: Balashikha
Zip: 143900
Country: Russian Federation

Facility:
Name: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)

Address:
City: Moscow
Zip: 105094
Country: Russian Federation

Facility:
Name: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)

Address:
City: Moscow
Zip: 125284
Country: Russian Federation

Facility:
Name: Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)

Address:
City: Nizhny Novgorod
Zip: 603081
Country: Russian Federation

Facility:
Name: Omsk Clinical Oncology Dispensary ( Site 1806)

Address:
City: Omsk
Zip: 644013
Country: Russian Federation

Facility:
Name: Sverdlovsk Regional Oncology Hospital ( Site 1807)

Address:
City: Ekaterinburg
Zip: 620036
Country: Russian Federation

Facility:
Name: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)

Address:
City: Kazan
Zip: 420029
Country: Russian Federation

Facility:
Name: Institute for Oncology and Radiology of Serbia ( Site 2995)

Address:
City: Belgrade
Zip: 11000
Country: Serbia

Facility:
Name: Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)

Address:
City: Sremska Kamenica
Zip: 21204
Country: Serbia

Facility:
Name: Steve Biko Academic Hospital ( Site 5000)

Address:
City: Pretoria
Zip: 0002
Country: South Africa

Facility:
Name: Groote Schuur Hospital ( Site 5002)

Address:
City: Cape Town
Zip: 7925
Country: South Africa

Facility:
Name: Hospital Universitario Central de Asturias ( Site 1900)

Address:
City: Oviedo
Zip: 33011
Country: Spain

Facility:
Name: Hospital Duran i Reynals ( Site 1903)

Address:
City: Hospitalet de Llobregat
Zip: 08908
Country: Spain

Facility:
Name: Hospital Universitari Vall d Hebron ( Site 1904)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre ( Site 1902)

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Regional Universitario de Malaga ( Site 1905)

Address:
City: Malaga
Zip: 29010
Country: Spain

Facility:
Name: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)

Address:
City: Sevilla
Zip: 41009
Country: Spain

Facility:
Name: Ankara Bilkent Sehir Hastanesi ( Site 2007)

Address:
City: Ankara
Zip: 06800
Country: Turkey

Facility:
Name: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)

Address:
City: Istanbul
Zip: 34098
Country: Turkey

Facility:
Name: Medipol Universite Hastanesi ( Site 2005)

Address:
City: Istanbul
Zip: 34214
Country: Turkey

Facility:
Name: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)

Address:
City: Istanbul
Zip: 34722
Country: Turkey

Facility:
Name: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

Address:
City: Izmir
Zip: 35040
Country: Turkey

Facility:
Name: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

Address:
City: Dnipro
Zip: 49055
Country: Ukraine

Facility:
Name: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)

Address:
City: Kharkiv
Zip: 61024
Country: Ukraine

Facility:
Name: Municipal non-profit Enterprise "Khmelnytskyi Regional Antitumor Center" ( Site 2115)

Address:
City: Khmelnytskyi
Zip: 29009
Country: Ukraine

Facility:
Name: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

Address:
City: Kapitanivka Village
Zip: 08111
Country: Ukraine

Facility:
Name: Clinic of National Cancer Institute ( Site 2101)

Address:
City: Kyiv
Zip: 03022
Country: Ukraine

Facility:
Name: Medical Center Verum ( Site 2106)

Address:
City: Kyiv
Zip: 03039
Country: Ukraine

Facility:
Name: LISOD. Hospital ( Site 2111)

Address:
City: Pliuty
Zip: 08720
Country: Ukraine

Facility:
Name: Communal Noncommercial Enterprise "Podillia Regional Oncolog-Chemotherapy Department ( Site 2114)

Address:
City: Vinnytsia
Zip: 21029
Country: Ukraine

Facility:
Name: Kyiv City Clinical Oncology Center ( Site 2100)

Address:
City: Kyiv
Zip: 03115
Country: Ukraine

Facility:
Name: Royal Infirmary Aberdeen ( Site 2403)

Address:
City: Aberdeen
Zip: AB25 2ZN
Country: United Kingdom

Facility:
Name: Ninewells Hospital and Medical School ( Site 2401)

Address:
City: Dundee
Zip: DD1 9SY
Country: United Kingdom

Facility:
Name: Taunton and Somerset Hospital ( Site 2404)

Address:
City: Taunton
Zip: TA1 5DA
Country: United Kingdom

Facility:
Name: Barts Health NHS Trust ( Site 2409)

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Facility:
Name: Guy s & St Thomas NHS Foundation Trust ( Site 2408)

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Facility:
Name: The Christie NHS Foundation Trust ( Site 2405)

Address:
City: Manchester
Zip: M20 4GJ
Country: United Kingdom

Start date: December 8, 2020

Completion date: October 28, 2027

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04624204
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7339-013&&kw=7339-013