Clinical trial NCT05722015: A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
Official title: A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Non-small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 377
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: This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.


Eligibility criteria: The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
* Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
* Has a life expectancy of at least 3 months

Exclusion Criteria:

* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
* Has received prior systemic anticancer therapy for metastatic NSCLC
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids
* Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* Has a history of human immunodeficiency virus (HIV) infection
* Has a history of Hepatitis B or C
* Has not adequately recovered from major surgery or has ongoing surgical complications
* Has a history of allogenic tissue/solid organ transplant

Primary outcomes:
measure: Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
timeFrame: At designated time points (Up to ~14 months).
measure: Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
timeFrame: At designated time points (Up to ~18 months)
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose
timeFrame: At designated time points (Up to ~28 months)
measure: Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose
timeFrame: At designated time points (Up to ~28 months)
measure: Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State
timeFrame: At designated time points (Up to ~28 months)
measure: Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State
timeFrame: At designated time points (Up to ~28 months)
measure: Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab
timeFrame: At designated time points (Up to ~28 months)
measure: Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to~60 months
measure: Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to~60 months
measure: Overall Survival (OS)
timeFrame: Up to~60 months
measure: Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to~60 months
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to~28 months
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to~25 months
measure: Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30
timeFrame: Baseline and up to ~28 months
measure: Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5
timeFrame: Baseline and up to ~28 months
measure: Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7
timeFrame: Baseline and up to ~28 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)
state: Arizona
city: Clermont
country: United States
facility: Clermont Oncology Center ( Site 0018)
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0010)
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc. ( Site 0011)
state: Illinois
city: Lafayette
country: United States
facility: Franciscan Health Lafayette East ( Site 0020)
state: Indiana
city: Paducah
country: United States
facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006)
state: Kentucky
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology ( Site 0008)
state: Mississippi
city: Bolivar
country: United States
facility: Central Care Cancer Center - Bolivar ( Site 0017)
state: Missouri
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming ( Site 1008)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 1003)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano-Oncology ( Site 1004)
city: Cordoba
country: Argentina
facility: Hospital Italiano de Córdoba ( Site 1000)
city: Fortaleza
country: Brazil
facility: CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)
state: Ceara
city: Recife
country: Brazil
facility: Hospital de Câncer de Recife ( Site 1107)
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100)
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)
state: Santa Catarina
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 1106)
city: La Serena
country: Chile
facility: IC La Serena Research ( Site 1207)
state: Coquimbo
city: Valdivia
country: Chile
facility: Oncocentro Valdivia ( Site 1201)
state: Los Rios
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 1203)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Oncovida ( Site 1209)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer-CR Investigación ( Site 1211)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 1202)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital,Capital Medical University ( Site 4511)
state: Beijing
city: Wanzhou
country: China
facility: Chongqing Three Gorges Central Hospital ( Site 4516)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 4517)
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Center Hospital ( Site 4509)
state: Guangdong
city: Shenzhen
country: China
facility: ShenZhen People's Hospital ( Site 4504)
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502)
state: Hubei
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Oncology ( Site 4512)
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital ( Site 4521)
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Chest Hospital ( Site 4518)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508)
state: Zhejiang
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)
state: Finistere
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)
state: Indre-et-Loire
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)
city: Ciudad de Guatemala
country: Guatemala
facility: Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)
city: Guatemala
country: Guatemala
facility: MEDI-K CAYALA ( Site 1403)
city: Quetzaltenango
country: Guatemala
facility: Centro Regional de Sub Especialidades Médicas SA ( Site 1401)
city: Quetzaltenango
country: Guatemala
facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)
state: Bacs-Kiskun
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)
state: Jasz-Nagykun-Szolnok
city: Törökbálint
country: Hungary
facility: Törökbálinti Tüdőgyógyintézet ( Site 2105)
state: Pest
city: Budapest
country: Hungary
facility: Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104)
city: Budapest
country: Hungary
facility: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)
city: Toyoake
country: Japan
facility: Fujita Health University ( Site 4406)
state: Aichi
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 4412)
state: Fukuoka
city: Otashi
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 4416)
state: Gunma
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center ( Site 4415)
state: Hokkaido
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 4404)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 4401)
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 4400)
state: Miyagi
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital ( Site 4409)
state: Okayama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 4408)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 4414)
state: Osaka
city: Ina-machi
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 4402)
state: Saitama
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center ( Site 4405)
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center ( Site 4417)
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital ( Site 4413)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 4411)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 4410)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 4407)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 4403)
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
state: Mazowieckie
city: Olsztyn
country: Poland
facility: Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii
state: Warminsko-mazurskie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)
state: Zachodniopomorskie
city: Florești
country: Romania
facility: SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301)
state: Dolj
city: Timișoara
country: Romania
facility: Cabinet Medical Oncomed ( Site 2305)
state: Timis
city: Cluj
country: Romania
facility: Institutul Oncologic-Oncologie Medicala ( Site 2302)
city: Port Elizabeth
country: South Africa
facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank ( Site 2907)
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital-Medical Oncology ( Site 2904)
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 2901)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials ( Site 2902)
state: Western Cape
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)
state: La Coruna
city: Madrid
country: Spain
facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital ( Site 4203)
state: Changhua
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 4205)
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)
city: Kaohsiung
country: Taiwan
facility: E-Da hospital ( Site 4208)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 4202)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 4204)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 4300)
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 4301)
state: Krung Thep Maha Nakhon
city: Siriraj
country: Thailand
facility: Division of Medical Oncology, Siriraj H ( Site 4303)
state: Krung Thep Maha Nakhon
city: Hatyai
country: Thailand
facility: Songklanagarind hospital ( Site 4302)
state: Songkhla
city: Izmir, Karsiyaka
country: Turkey
facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)
state: Izmir
city: Ankara
country: Turkey
facility: Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)
city: Ankara
country: Turkey
facility: Ankara City Hospital-Medical Oncology ( Site 2501)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
city: Kayseri
country: Turkey
facility: Memorial Kayseri Hastanesi ( Site 2500)
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: