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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)

Primary Purpose

Non-Small Cell Lung Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab SC

Pembrolizumab IV

Paclitaxel

Nab-Paclitaxel

Carboplatin

Cisplatin

Pemetrexed

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death-Ligand 1 (PDL1, PD-L1), Programmed Cell Death-Ligand 2 (PDL2, PD-L2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Bernards Medical Center ( Site 0103)
St Joseph Heritage Healthcare-Oncology ( Site 0102)
Cancer Blood and Specialty Clinic ( Site 0105)
PIH Health Hematology Medical Oncology ( Site 0106)
Holy Cross Hospital ( Site 0017)
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)
Advent Health ( Site 0013)
Fort Wayne Medical Oncology and Hematology ( Site 0101)
Baptist Health Lexington ( Site 0099)
St Luke's Hospital - Kansas City ( Site 0033)
St. Vincent Frontier Cancer Center ( Site 0058)
Montefiore Medical Center [Bronx, NY] ( Site 0040)
The University of Tennessee Medical Center ( Site 0050)
Tennessee Oncology ( Site 0051)
Oncology Consultants, PA ( Site 0052)
Millennium Physicians - Oncology ( Site 0097)
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)
West Virginia University ( Site 0056)
HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)
Hospital Sao Vicente de Paulo ( Site 0311)
Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)
Nouvel Hôpital Civil (NHC) ( Site 1018)
CHU Limoges CHU Dupuytren ( Site 1011)
Hôpital Foch ( Site 1019)
Institut Regional du Cancer de Montpellier - ICM ( Site 1003)
Centre Hospitalier Sud Réunion ( Site 1020)
Hopital Guillaume & Rene Laennec ( Site 1007)
Centre Hospitalier de Pau ( Site 1016)
CHU de Rouen ( Site 1013)
Hopital Cochin ( Site 1002)
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)
Clinica Privada Dr. Rixci Ramirez ( Site 0601)
INTERVASC ( Site 0605)
Grupo Angeles SA ( Site 0604)
Centro Regional de Sub Especialidades Médicas SA ( Site 0600)
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)
Petz Aladar Megyei Oktato Korhaz ( Site 1110)
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)
Tudogyogyintezet Torokbalint ( Site 1105)
Veszprem Megyei Tudogyogyintezet ( Site 1108)
Zala Megyei Szent Rafael Korhaz ( Site 1111)
Semmelweis University-Pulmonológiai Klinika ( Site 1114)
Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)
Fujita Health University Hospital ( Site 3007)
Ehime University Hospital ( Site 3005)
Kurume University Hospital ( Site 3006)
National Hospital Organization Hokkaido Cancer Center ( Site 3014)
Kanazawa University Hospital ( Site 3004)
Kanagawa Cardiovascular and Respiratory Center ( Site 3003)
Miyagi Cancer Center ( Site 3000)
Sendai Kousei Hospital ( Site 3015)
Kurashiki Central Hospital ( Site 3013)
Kansai Medical University Hospital ( Site 3016)
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)
Osaka Medical and Pharmaceutical University Hospital ( Site 3017)
Chiba University Hospital ( Site 3008)
National Hospital Organization Kyushu Medical Center ( Site 3001)
National Hospital Organization Kyushu Cancer Center ( Site 3002)
Okayama University Hospital ( Site 3012)
Osaka International Cancer Institute ( Site 3018)
Tokushima University Hospital ( Site 3019)
Juntendo University Hospital ( Site 3011)
Showa University Hospital ( Site 3010)
Chungnam National University Hospital ( Site 2002)
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)
Korea University Guro Hospital ( Site 2003)
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)
Clínica Peruano-Americana de Trujillo ( Site 0701)
Oncosalud ( Site 0706)
Clinica Internacional Sede San Borja ( Site 0705)
Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)
Hospital Nacional Cayetano Heredia ( Site 0700)
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)
Przychodnia Lekarska KOMED ( Site 1202)
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)
Cardiomed SRL Cluj-Napoca ( Site 1313)
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)
SC Radiotherapy Center Cluj SRL ( Site 1307)
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)
Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)
Spitalul Municipal Ploiesti ( Site 1308)
Policlinica Oncomed SRL ( Site 1302)
S.C.Focus Lab Plus S.R.L ( Site 1301)
Spitalul Universitar de Urgenta Bucuresti ( Site 1305)
SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)
Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)
Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)
SPb SBHI City Clinical Oncological Dispensary ( Site 1409)
Wits Clinical Research ( Site 1510)
Steve Biko Academic Hospital ( Site 1506)
Marry Potter Oncology Centre ( Site 1502)
Sandton Oncology Medical Group PTY LTD ( Site 1505)
Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)
The Oncology Centre ( Site 1507)
Cape Town Oncology Trials Pty Ltd ( Site 1500)
Hospital Insular de Gran Canaria-Oncology ( Site 1604)
H.U. Vall de Hebron ( Site 1600)
Hospital Juan Ramon Jimenez ( Site 1602)
Hospital Universitario Lucus Augusti ( Site 1603)
Hospital Universitario La Paz ( Site 1601)
Changhua Christian Hospital ( Site 2104)
National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)
National Cheng Kung University Hospital ( Site 2105)
National Taiwan University Hospital ( Site 2101)
Taipei Veterans General Hospital ( Site 2106)
Chang Gung Medical Foundation-Linkou Branch ( Site 2102)
Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)
Ankara Sehir Hastanesi ( Site 1702)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)
Medical Center Mriya Med-Service ( Site 1805)
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)
Ukrainian Center of Tomotherapy ( Site 1807)
Medical Center Asklepion LLC ( Site 1804)
Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181
Kremenchuk Regional Oncology Center ( Site 1811)
Kyiv City Clinical Oncology Centre ( Site 1809)
Medical Center Dobrobut Clinic ( Site 1808)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy

Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy

Arm Description

Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous NSCLC.

Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous NSCLC.

Outcomes

Primary Outcome Measures

Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab at Cycle 1

AUC0-3wks at Cycle 1 is defined as the area under curve exposure parameter over a 3-week dosing interval in Cycle 1.

Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab

Cycle 6 model-based Ctrough is defined as the trough concentration predicted by the PK model at the end of the dosing interval in Cycle 6.

Secondary Outcome Measures

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.

Observed Ctrough of Pembrolizumab at the End of Cycle 1

Ctrough of Cycle 1 is defined as the observed trough concentration at the end of the dosing interval in Cycle 1.

Maximum Concentration (Cmax) of Pembrolizumab at Cycle 1

Cmax at Cycle 1 is defined as the observed peak concentration over the dosing interval in Cycle 1.

AUC 0-3wks of Pembrolizumab at Cycle 6

AUC0-3wks at Cycle 6 is defined as the area under curve exposure parameter over a 3-week dosing interval in Cycle 6.

Cmax of Pembrolizumab at Cycle 6

Cmax at Cycle 6 is defined as the observed peak concentration over the dosing interval in Cycle 6.

Observed Ctrough of Pembrolizumab at the End of Cycle 6

Ctrough of Cycle 6 is defined as the observed trough concentration measured at the end of the dosing interval in Cycle 6.

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.

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.

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.

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause.

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.

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.

Full Information

NCT ID

NCT04956692

First Posted

July 6, 2021

Last Updated

August 31, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04956692

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 5, 2021 (Actual)

Primary Completion Date

April 4, 2023 (Actual)

Study Completion Date

October 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

531 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab SC

Intervention Description

SC injection

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab IV

Other Intervention Name(s)

MK-3475, KEYTRUDA®, SCH 900475

Intervention Description

IV injection

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Nov-Onxol, Onxol, Paclitaxel Novaplus, Taxol

Intervention Description

IV injection

Intervention Type

Drug

Intervention Name(s)

Nab-Paclitaxel

Other Intervention Name(s)

Abraxane, Nanoparticle albumin-bound paclitaxel

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin, Paraplatin NovaPlus

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol-AQ

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

LY231514, Alimta, Pemetrexed Disodium

Intervention Description

IV infusion

Primary Outcome Measure Information:

Title

Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab at Cycle 1

Description

AUC0-3wks at Cycle 1 is defined as the area under curve exposure parameter over a 3-week dosing interval in Cycle 1.

Time Frame

Pharmacokinetic (PK) collection at designated timepoints in Cycle 1 (Up to approximately 3 weeks; cycle length = 3 weeks)

Title

Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab

Description

Cycle 6 model-based Ctrough is defined as the trough concentration predicted by the PK model at the end of the dosing interval in Cycle 6.

Time Frame

PK collection at end of Cycle 6 (approximately at end of Week 18; cycle length = 3 weeks)

Secondary Outcome Measure Information:

Title

Objective Response (OR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Description

Time Frame

Up to approximately 5 years

Title

Observed Ctrough of Pembrolizumab at the End of Cycle 1

Description

Ctrough of Cycle 1 is defined as the observed trough concentration at the end of the dosing interval in Cycle 1.

Time Frame

PK collection at end of Cycle 1 (approximately at end of Week 3; cycle length = 3 weeks)

Title

Maximum Concentration (Cmax) of Pembrolizumab at Cycle 1

Description

Cmax at Cycle 1 is defined as the observed peak concentration over the dosing interval in Cycle 1.

Time Frame

PK collection at designated timepoints in Cycle 1 (Up to approximately 3 weeks; cycle length = 3 weeks)

Title

AUC 0-3wks of Pembrolizumab at Cycle 6

Description

AUC0-3wks at Cycle 6 is defined as the area under curve exposure parameter over a 3-week dosing interval in Cycle 6.

Time Frame

PK collection at designated timepoints in Cycle 6 (Up to approximately 3 weeks; cycle length = 3 weeks)

Title

Cmax of Pembrolizumab at Cycle 6

Description

Cmax at Cycle 6 is defined as the observed peak concentration over the dosing interval in Cycle 6.

Time Frame

PK collection at designated timepoints in Cycle 6 (Up to approximately 3 weeks; cycle length = 3 weeks)

Title

Observed Ctrough of Pembrolizumab at the End of Cycle 6

Description

Ctrough of Cycle 6 is defined as the observed trough concentration measured at the end of the dosing interval in Cycle 6.

Time Frame

PK collection at end of Cycle 6 (approximately at end of Week 18; cycle length = 3 weeks)

Title

Number of Participants Who Experienced an Adverse Event (AE)

Description

Time Frame

Up to approximately 28 months

Title

Number of Participants Who Discontinued Study Treatment Due to an AE

Description

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.

Time Frame

Up to approximately 25 months

Title

Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR

Description

Time Frame

Up to approximately 5 years

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization to death due to any cause.

Time Frame

Up to approximately 5 years

Title

Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

Description

Time Frame

Up to approximately 5 years

Title

Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab

Description

ADA incidence will be assessed by analyzing the development of ADAs following administration of pembrolizumab SC and pembrolizumab IV.

Time Frame

Up to approximately 26 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

St. Bernards Medical Center ( Site 0103)

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

St Joseph Heritage Healthcare-Oncology ( Site 0102)

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Cancer Blood and Specialty Clinic ( Site 0105)

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

PIH Health Hematology Medical Oncology ( Site 0106)

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

Facility Name

Holy Cross Hospital ( Site 0017)

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Advent Health ( Site 0013)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Fort Wayne Medical Oncology and Hematology ( Site 0101)

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Baptist Health Lexington ( Site 0099)

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

St Luke's Hospital - Kansas City ( Site 0033)

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

St. Vincent Frontier Cancer Center ( Site 0058)

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

Montefiore Medical Center [Bronx, NY] ( Site 0040)

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

The University of Tennessee Medical Center ( Site 0050)

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Tennessee Oncology ( Site 0051)

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Oncology Consultants, PA ( Site 0052)

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Millennium Physicians - Oncology ( Site 0097)

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)

City

Blacksburg

State/Province

Virginia

ZIP/Postal Code

24060

Country

United States

Facility Name

West Virginia University ( Site 0056)

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)

City

Cachoeiro de Itapemirim

State/Province

Espirito Santo

ZIP/Postal Code

29308-065

Country

Brazil

Facility Name

Hospital Sao Vicente de Paulo ( Site 0311)

City

Passo Fundo

State/Province

Rio Grande Do Sul

ZIP/Postal Code

99010-080

Country

Brazil

Facility Name

Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)

City

Joinville

State/Province

Santa Catarina

ZIP/Postal Code

89201260

Country

Brazil

Facility Name

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)

City

Sao Jose do Rio Preto

State/Province

Sao Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Nouvel Hôpital Civil (NHC) ( Site 1018)

City

Strasbourg

State/Province

Bas-Rhin

ZIP/Postal Code

67091

Country

France

Facility Name

CHU Limoges CHU Dupuytren ( Site 1011)

City

Limoges

State/Province

Haute-Vienne

ZIP/Postal Code

87042

Country

France

Facility Name

Hôpital Foch ( Site 1019)

City

Suresnes

State/Province

Hauts-de-Seine

ZIP/Postal Code

92150

Country

France

Facility Name

Institut Regional du Cancer de Montpellier - ICM ( Site 1003)

City

Montpellier

State/Province

Herault

ZIP/Postal Code

34298

Country

France

Facility Name

Centre Hospitalier Sud Réunion ( Site 1020)

City

Saint-Pierre

State/Province

La Reunion

ZIP/Postal Code

97448

Country

France

Facility Name

Hopital Guillaume & Rene Laennec ( Site 1007)

City

Saint-Herblain

State/Province

Loire-Atlantique

ZIP/Postal Code

44800

Country

France

Facility Name

Centre Hospitalier de Pau ( Site 1016)

City

Pau

State/Province

Pyrenees-Atlantiques

ZIP/Postal Code

64000

Country

France

Facility Name

CHU de Rouen ( Site 1013)

City

Rouen

State/Province

Seine-Maritime

ZIP/Postal Code

76031

Country

France

Facility Name

Hopital Cochin ( Site 1002)

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Clinica Privada Dr. Rixci Ramirez ( Site 0601)

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

INTERVASC ( Site 0605)

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Grupo Angeles SA ( Site 0604)

City

Guatemala

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Centro Regional de Sub Especialidades Médicas SA ( Site 0600)

City

Quetzaltenango

ZIP/Postal Code

09001

Country

Guatemala

Facility Name

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)

City

Kecskemét

State/Province

Bacs-Kiskun

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Petz Aladar Megyei Oktato Korhaz ( Site 1110)

City

Gyor

State/Province

Gyor-Moson-Sopron

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)

City

Szolnok

State/Province

Jasz-Nagykun-Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Tudogyogyintezet Torokbalint ( Site 1105)

City

Torokbalint

State/Province

Pest

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Veszprem Megyei Tudogyogyintezet ( Site 1108)

City

Farkasgyepu

State/Province

Veszprem

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Zala Megyei Szent Rafael Korhaz ( Site 1111)

City

Zalagerszeg

State/Province

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Semmelweis University-Pulmonológiai Klinika ( Site 1114)

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Fujita Health University Hospital ( Site 3007)

City

Toyoake

State/Province

Aichi

ZIP/Postal Code

4701192

Country

Japan

Facility Name

Ehime University Hospital ( Site 3005)

City

Toon

State/Province

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Kurume University Hospital ( Site 3006)

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

National Hospital Organization Hokkaido Cancer Center ( Site 3014)

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Kanazawa University Hospital ( Site 3004)

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Kanagawa Cardiovascular and Respiratory Center ( Site 3003)

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0051

Country

Japan

Facility Name

Miyagi Cancer Center ( Site 3000)

City

Natori

State/Province

Miyagi

ZIP/Postal Code

981-1293

Country

Japan

Facility Name

Sendai Kousei Hospital ( Site 3015)

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

980-0873

Country

Japan

Facility Name

Kurashiki Central Hospital ( Site 3013)

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8602

Country

Japan

Facility Name

Kansai Medical University Hospital ( Site 3016)

City

Hirakata

State/Province

Osaka

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)

City

Sakai

State/Province

Osaka

Country

Japan

Facility Name

Osaka Medical and Pharmaceutical University Hospital ( Site 3017)

City

Takatsuki

State/Province

Osaka

ZIP/Postal Code

569-8686

Country

Japan

Facility Name

Chiba University Hospital ( Site 3008)

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

National Hospital Organization Kyushu Medical Center ( Site 3001)

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

Facility Name

National Hospital Organization Kyushu Cancer Center ( Site 3002)

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Okayama University Hospital ( Site 3012)

City

Okayama

ZIP/Postal Code

7008558

Country

Japan

Facility Name

Osaka International Cancer Institute ( Site 3018)

City

Osaka

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Tokushima University Hospital ( Site 3019)

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Juntendo University Hospital ( Site 3011)

City

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Showa University Hospital ( Site 3010)

City

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Chungnam National University Hospital ( Site 2002)

City

Daejeon

State/Province

Chungnam

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)

City

Hwasun

State/Province

Jeonranamdo

ZIP/Postal Code

58128

Country

Korea, Republic of

Facility Name

Korea University Guro Hospital ( Site 2003)

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)

City

Arequipa

State/Province

Ariqipa

ZIP/Postal Code

04001

Country

Peru

Facility Name

Clínica Peruano-Americana de Trujillo ( Site 0701)

City

Trujillo

State/Province

La Libertad

ZIP/Postal Code

13007

Country

Peru

Facility Name

Oncosalud ( Site 0706)

City

Lima

State/Province

Muni Metro De Lima

ZIP/Postal Code

15036

Country

Peru

Facility Name

Clinica Internacional Sede San Borja ( Site 0705)

City

Lima

ZIP/Postal Code

15036

Country

Peru

Facility Name

Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)

City

Lima

ZIP/Postal Code

15038

Country

Peru

Facility Name

Hospital Nacional Cayetano Heredia ( Site 0700)

City

Lima

ZIP/Postal Code

15102

Country

Peru

Facility Name

Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)

City

Bydgoszcz

State/Province

Kujawsko-pomorskie

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)

City

Siedlce

State/Province

Mazowieckie

ZIP/Postal Code

08-110

Country

Poland

Facility Name

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)

City

Bystra

State/Province

Slaskie

ZIP/Postal Code

43-360

Country

Poland

Facility Name

Przychodnia Lekarska KOMED ( Site 1202)

City

Konin

State/Province

Wielkopolskie

ZIP/Postal Code

62-500

Country

Poland

Facility Name

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)

City

Koszalin

State/Province

Zachodniopomorskie

ZIP/Postal Code

75-581

Country

Poland

Facility Name

Cardiomed SRL Cluj-Napoca ( Site 1313)

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

SC Radiotherapy Center Cluj SRL ( Site 1307)

City

Comuna Floresti

State/Province

Cluj

ZIP/Postal Code

407280

Country

Romania

Facility Name

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200347

Country

Romania

Facility Name

Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200385

Country

Romania

Facility Name

Spitalul Municipal Ploiesti ( Site 1308)

City

Ploiesti

State/Province

Prahova

ZIP/Postal Code

100337

Country

Romania

Facility Name

Policlinica Oncomed SRL ( Site 1302)

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300239

Country

Romania

Facility Name

S.C.Focus Lab Plus S.R.L ( Site 1301)

City

Bucuresti

ZIP/Postal Code

022548

Country

Romania

Facility Name

Spitalul Universitar de Urgenta Bucuresti ( Site 1305)

City

Bucuresti

ZIP/Postal Code

050098

Country

Romania

Facility Name

SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)

City

Kazan

State/Province

Tatarstan, Respublika

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

SPb SBHI City Clinical Oncological Dispensary ( Site 1409)

City

Sankt-Peterburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Wits Clinical Research ( Site 1510)

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Steve Biko Academic Hospital ( Site 1506)

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Marry Potter Oncology Centre ( Site 1502)

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Sandton Oncology Medical Group PTY LTD ( Site 1505)

City

Sandton

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)

City

Soweto

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

The Oncology Centre ( Site 1507)

City

Durban

State/Province

Limpopo

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Cape Town Oncology Trials Pty Ltd ( Site 1500)

City

Kraaifontein

State/Province

Western Cape

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Hospital Insular de Gran Canaria-Oncology ( Site 1604)

City

Las Palmas de Gran Canaria

State/Province

Las Palmas

ZIP/Postal Code

35001

Country

Spain

Facility Name

H.U. Vall de Hebron ( Site 1600)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Juan Ramon Jimenez ( Site 1602)

City

Huelva

ZIP/Postal Code

21005

Country

Spain

Facility Name

Hospital Universitario Lucus Augusti ( Site 1603)

City

Lugo

ZIP/Postal Code

27003

Country

Spain

Facility Name

Hospital Universitario La Paz ( Site 1601)

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Changhua Christian Hospital ( Site 2104)

City

Changhua

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)

City

Hsinchu

ZIP/Postal Code

300

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

National Cheng Kung University Hospital ( Site 2105)

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital ( Site 2101)

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Taipei Veterans General Hospital ( Site 2106)

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Medical Foundation-Linkou Branch ( Site 2102)

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)

City

Ankara

ZIP/Postal Code

06010

Country

Turkey

Facility Name

Ankara Sehir Hastanesi ( Site 1702)

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

Facility Name

Medical Center Mriya Med-Service ( Site 1805)

City

Kryvyi Rih

State/Province

Dnipropetrovska Oblast

ZIP/Postal Code

50000

Country

Ukraine

Facility Name

Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)

City

Kharkiv

State/Province

Kharkivska Oblast

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Ukrainian Center of Tomotherapy ( Site 1807)

City

Kropyvnytskyi

State/Province

Kirovohradska Oblast

ZIP/Postal Code

25011

Country

Ukraine

Facility Name

Medical Center Asklepion LLC ( Site 1804)

City

Khodosivka

State/Province

Kyivska Oblast

ZIP/Postal Code

08173

Country

Ukraine

Facility Name

Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181

City

Odesa

State/Province

Odeska Oblast

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Kremenchuk Regional Oncology Center ( Site 1811)

City

Kremenchuk

State/Province

Poltavska Oblast

ZIP/Postal Code

39617

Country

Ukraine

Facility Name

Kyiv City Clinical Oncology Centre ( Site 1809)

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Medical Center Dobrobut Clinic ( Site 1808)

City

Kyiv

ZIP/Postal Code

03151

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Links:

URL

https://www.merckclinicaltrials.com/

Description

Merck Clinical Trials Information

Learn more about this trial

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