Clinical trial NCT04956692: Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
Official title: A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Programmed Cell Death 1 (PD1, PD-1)
Programmed Cell Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death-Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.

Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.


Eligibility criteria: Inclusion Criteria:

* Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)
* Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC
* Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing
* Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease
* Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1
* Male participants are eligible to participate if they agree to use contraception as per protocol unless confirmed to be azoospermic
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method per protocol
* Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
* Submit an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization
* Has adequate organ function

Exclusion Criteria:

* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per local site assessment
* Has severe hypersensitivity to study intervention and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B infection or known active Hepatitis C infection
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible
* Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (\<3 weeks prior to first dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Received radiation therapy to the lung that is \>30 Gray within 6 months of the first dose of study intervention
* Is expected to require any other form of antineoplastic therapy while on study
* For participants with nonsquamous histology: Is unable to interrupt aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period
* For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation
* Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
* Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
* 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
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab
timeFrame: Cycle 1: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.
measure: Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab
timeFrame: Cycle 6: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.
Secondary outcomes:
measure: Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 5 years
measure: Cycle 1 Observed Ctrough of Pembrolizumab
timeFrame: Predose Cycle 2 day 1. Each cycle is 21 days.
measure: Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab
timeFrame: Cycle 1: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.
measure: Cycle 6 AUC 0-3wks of Pembrolizumab
timeFrame: Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.
measure: Cycle 6 Cmax of Pembrolizumab
timeFrame: Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.
measure: Cycle 6 Observed Ctrough of Pembrolizumab
timeFrame: Predose Cycle 7 day 1. Each cycle is 21 days.
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 28 months
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 25 months
measure: Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 5 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 5 years
measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 5 years
measure: Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab
timeFrame: Up to approximately 26 months
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernards Medical Center ( Site 0103)
state: Arkansas
city: Fullerton
country: United States
facility: St Joseph Heritage Healthcare-Oncology ( Site 0102)
state: California
city: Los Alamitos
country: United States
facility: Cancer Blood and Specialty Clinic ( Site 0105)
state: California
city: Whittier
country: United States
facility: PIH Health Hematology Medical Oncology ( Site 0106)
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital ( Site 0017)
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)
state: Florida
city: Orlando
country: United States
facility: Advent Health ( Site 0013)
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology ( Site 0101)
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington ( Site 0099)
state: Kentucky
city: Kansas City
country: United States
facility: St Luke's Hospital - Kansas City ( Site 0033)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center ( Site 0058)
state: Montana
city: Bronx
country: United States
facility: Montefiore Medical Center [Bronx, NY] ( Site 0040)
state: New York
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center ( Site 0050)
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology ( Site 0051)
state: Tennessee
city: Houston
country: United States
facility: Oncology Consultants, PA ( Site 0052)
state: Texas
city: Houston
country: United States
facility: Millennium Physicians - Oncology ( Site 0097)
state: Texas
city: Blacksburg
country: United States
facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University ( Site 0056)
state: West Virginia
city: Cachoeiro de Itapemirim
country: Brazil
facility: HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)
state: Espirito Santo
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo ( Site 0311)
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)
state: Sao Paulo
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil (NHC) ( Site 1018)
state: Bas-Rhin
city: Limoges
country: France
facility: CHU Limoges CHU Dupuytren ( Site 1011)
state: Haute-Vienne
city: Suresnes
country: France
facility: Hôpital Foch ( Site 1019)
state: Hauts-de-Seine
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1003)
state: Herault
city: Saint-Pierre
country: France
facility: Centre Hospitalier Sud Réunion ( Site 1020)
state: La Reunion
city: Saint-Herblain
country: France
facility: Hopital Guillaume & Rene Laennec ( Site 1007)
state: Loire-Atlantique
city: Pau
country: France
facility: Centre Hospitalier de Pau ( Site 1016)
state: Pyrenees-Atlantiques
city: Rouen
country: France
facility: CHU de Rouen ( Site 1013)
state: Seine-Maritime
city: Paris
country: France
facility: Hopital Cochin ( Site 1002)
city: Guatemala
country: Guatemala
facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)
city: Guatemala
country: Guatemala
facility: Clinica Privada Dr. Rixci Ramirez ( Site 0601)
city: Guatemala
country: Guatemala
facility: INTERVASC ( Site 0605)
city: Guatemala
country: Guatemala
facility: Grupo Angeles SA ( Site 0604)
city: Quetzaltenango
country: Guatemala
facility: Centro Regional de Sub Especialidades Médicas SA ( Site 0600)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)
state: Bacs-Kiskun
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 1110)
state: Gyor-Moson-Sopron
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)
state: Jasz-Nagykun-Szolnok
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint ( Site 1105)
state: Pest
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet ( Site 1108)
state: Veszprem
city: Zalagerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz ( Site 1111)
state: Zalaegerszeg
city: Budapest
country: Hungary
facility: Semmelweis University-Pulmonológiai Klinika ( Site 1114)
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 3007)
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 3005)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 3006)
state: Fukuoka
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center ( Site 3014)
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 3004)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 3003)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 3000)
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 3015)
state: Miyagi
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital ( Site 3013)
state: Okayama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 3016)
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3017)
state: Osaka
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 3008)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 3001)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 3002)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 3012)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 3018)
city: Tokushima
country: Japan
facility: Tokushima University Hospital ( Site 3019)
city: Tokyo
country: Japan
facility: Juntendo University Hospital ( Site 3011)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 3010)
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital ( Site 2002)
state: Chungnam
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 2003)
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)
state: Ariqipa
city: Trujillo
country: Peru
facility: Clínica Peruano-Americana de Trujillo ( Site 0701)
state: La Libertad
city: Lima
country: Peru
facility: Oncosalud ( Site 0706)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: Clinica Internacional Sede San Borja ( Site 0705)
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia ( Site 0700)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)
state: Kujawsko-pomorskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Bystra
country: Poland
facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)
state: Slaskie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED ( Site 1202)
state: Wielkopolskie
city: Koszalin
country: Poland
facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)
state: Zachodniopomorskie
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 1313)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)
state: Cluj
city: Comuna Floresti
country: Romania
facility: SC Radiotherapy Center Cluj SRL ( Site 1307)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)
state: Dolj
city: Craiova
country: Romania
facility: Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)
state: Dolj
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti ( Site 1308)
state: Prahova
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 1302)
state: Timis
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 1301)
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti ( Site 1305)
city: Saint-Petersburg
country: Russian Federation
facility: SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)
state: Tatarstan, Respublika
city: Sankt-Peterburg
country: Russian Federation
facility: SPb SBHI City Clinical Oncological Dispensary ( Site 1409)
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 1510)
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital ( Site 1506)
state: Gauteng
city: Pretoria
country: South Africa
facility: Marry Potter Oncology Centre ( Site 1502)
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group PTY LTD ( Site 1505)
state: Gauteng
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 1507)
state: Limpopo
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials Pty Ltd ( Site 1500)
state: Western Cape
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 1604)
state: Las Palmas
city: Barcelona
country: Spain
facility: H.U. Vall de Hebron ( Site 1600)
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez ( Site 1602)
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti ( Site 1603)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 1601)
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 2104)
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2105)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2101)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 2106)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2102)
city: Ankara
country: Turkey
facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 1702)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)
city: Kryvyi Rih
country: Ukraine
facility: Medical Center Mriya Med-Service ( Site 1805)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)
state: Kharkivska Oblast
city: Kropyvnytskyi
country: Ukraine
facility: Ukrainian Center of Tomotherapy ( Site 1807)
state: Kirovohradska Oblast
city: Khodosivka
country: Ukraine
facility: Medical Center Asklepion LLC ( Site 1804)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181
state: Odeska Oblast
city: Kremenchuk
country: Ukraine
facility: Kremenchuk Regional Oncology Center ( Site 1811)
state: Poltavska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 1809)
city: Kyiv
country: Ukraine
facility: Medical Center Dobrobut Clinic ( Site 1808)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: