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)

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04956692
• Other study ID #: 3475-A86
• Secondary ID: MK-3475-A86jRCT2
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 5, 2021
• Est. completion date: October 14, 2026

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 531
• Est. completion date: October 14, 2026
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Biological:
• Pembrolizumab SC
SC injection
• Pembrolizumab IV
IV injection

Drug:
• Paclitaxel
IV injection
• Nab-Paclitaxel
IV infusion
• Carboplatin
IV infusion
• Cisplatin
IV infusion
• Pemetrexed
IV infusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Brazil,  France,  Guatemala,  Hungary,  Japan,  Korea, Republic of,  Peru,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab	Cycle 1 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 1. Each cycle is 21 days.	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.
Primary	Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab	Cycle 6 model-based Ctrough is defined as the lowest concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6, as predicted by the pharmacokinetic (PK) model based on historical intravenous pembrolizumab PK data. Each cycle is 21 days.	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	Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	The OR rate is defined as the percentage of participants who achieve a confirmed complete response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.	Up to approximately 5 years
Secondary	Cycle 1 Observed Ctrough of Pembrolizumab	Cycle 1 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 1. Each cycle is 21 days.	Predose Cycle 2 day 1. Each cycle is 21 days.
Secondary	Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab	Cycle 1 Cmax is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 1. Each cycle is 21 days.	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.
Secondary	Cycle 6 AUC 0-3wks of Pembrolizumab	Cycle 6 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 6. Each cycle is 21 days.	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.
Secondary	Cycle 6 Cmax of Pembrolizumab	Cmax in Cycle 6 is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 6. Each cycle is 21 days.	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.
Secondary	Cycle 6 Observed Ctrough of Pembrolizumab	Cycle 6 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6. Each cycle is 21 days.	Predose Cycle 7 day 1. Each cycle is 21 days.
Secondary	Number of Participants Who Experienced an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.	Up to approximately 28 months
Secondary	Number of Participants Who Discontinued Study Treatment Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who discontinue study treatment due to an AE will be presented.	Up to approximately 25 months
Secondary	Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR	PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. 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 new lesions is also considered PD.	Up to approximately 5 years
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 5 years
Secondary	Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	For participants who show confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD.	Up to approximately 5 years
Secondary	Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab	ADA incidence will be assessed by analyzing the development of ADAs following administration of pembrolizumab SC and pembrolizumab IV.	Up to approximately 26 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary