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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-U01 | Other Identifier | MSD | |
| KEYMAKER-U01 | Other Identifier | MSD |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.
The following pembrolizumab substudies will evaluate the efficacy of different investigational agents in combination with pembrolizumab given in sequence or in combination with pembrolizumab PLUS chemotherapy:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective NSCLC Participants | Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC will be screened for participation in 1 of several pembrolizumab substudies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Imaging | Diagnostic Test | Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan. |
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| Measure | Description | Time Frame |
|---|---|---|
| Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% | Participants' tumors will be evaluated for their PD-L1 tumor expression level using archival tumor tissue samples or newly obtained tumor tissue. The percentage of participants who have a Tumor Proportion Score (TPS) <1% vs. a TPS =1% will be presented. | Up to approximately 1 month |
| Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC | Participants' tumors will be evaluated for their tumor histology status as being either squamous vs. nonsquamous NSCLC using archival or newly obtained tumor tissue samples. The percentage of participants who have squamous vs. nonsquamous NSCLC will be presented. | Up to approximately 1 month |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0001) | Completed | Gilbert | Arizona | 85234 | United States | |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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To identify novel biomarkers, biospecimens (i.e., blood components, tumor material) will be collected to support analyses of cellular components (eg, protein, DNA, RNA, metabolites) and other circulating molecules.
Investigations may include but are not limited to:
Tumour tissue analyses, germline (blood) genetic analyses (e.g. single nucleotide polymorphism [SNP] analyses, whole exome sequencing, whole genome sequencing)
| Tumor Tissue Collection | Procedure | Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue. |
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| Blood Sample Collection | Procedure | Participants will have blood samples drawn for analysis of:
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| City of Hope ( Site 0014) |
| Completed |
| Duarte |
| California |
| 91010 |
| United States |
| UCSF Medical Center at Mission Bay ( Site 0007) | Completed | San Francisco | California | 94158 | United States |
| Georgetown University ( Site 0036) | Completed | Washington D.C. | District of Columbia | 20007 | United States |
| University of Kentucky Markey Cancer Center ( Site 0019) | Completed | Lexington | Kentucky | 40536-0293 | United States |
| MedStar Franklin Square Medical Center ( Site 0033) | Completed | Baltimore | Maryland | 21237 | United States |
| Massachusetts General Hospital ( Site 0003) | Completed | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute ( Site 0002) | Completed | Boston | Massachusetts | 02215 | United States |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) | Completed | Omaha | Nebraska | 68130 | United States |
| Dartmouth Hitchcock Medical Center ( Site 0016) | Recruiting | Lebanon | New Hampshire | 03766 | United States |
|
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) | Completed | Hackensack | New Jersey | 07601 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034) | Completed | New York | New York | 10016 | United States |
| Sanford Fargo Medical Center ( Site 0039) | Recruiting | Fargo | North Dakota | 58102 | United States |
|
| Cleveland Clinic Main ( Site 0006) | Completed | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center ( Site 0015) | Recruiting | Columbus | Ohio | 43210 | United States |
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| Abramson Cancer Center of the University of Pennsylvania ( Site 0010) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Sanford Cancer Center ( Site 0038) | Recruiting | Sioux Falls | South Dakota | 57104 | United States |
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| The University of Texas MD Anderson Cancer Center ( Site 0009) | Recruiting | Houston | Texas | 77030 | United States |
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| Petz Aladar Megyei Oktato Korhaz ( Site 0062) | Completed | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) | Completed | Szolnok | Jász-Nagykun-Szolnok | 5004 | Hungary |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) | Completed | Budapest | 1121 | Hungary |
| Soroka Medical Center ( Site 0072) | Completed | Beersheba | 8457108 | Israel |
| Rambam Health Care Campus-Oncology ( Site 0076) | Completed | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center ( Site 0075) | Recruiting | Jerusalem | 9103102 | Israel |
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| Meir Medical Center ( Site 0071) | Completed | Kfar Saba | 4428132 | Israel |
| Rabin Medical Center ( Site 0074) | Completed | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center ( Site 0070) | Recruiting | Ramat Gan | 5262000 | Israel |
|
| Sourasky Medical Center ( Site 0077) | Completed | Tel Aviv | 6423906 | Israel |
| Azienda Ospedaliera Universitaria Careggi ( Site 0173) | Completed | Florence | Firenze | 50134 | Italy |
| IRCCS Ospedale San Raffaele ( Site 0171) | Completed | Milan | 20132 | Italy |
| Policlinico Gemelli di Roma ( Site 0174) | Completed | Roma | 00168 | Italy |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151) | Recruiting | Warsaw | Masovian Voivodeship | 02-781 | Poland |
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| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) | Active, not recruiting | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152) | Active, not recruiting | Koszalin | West Pomeranian Voivodeship | 75-581 | Poland |
| Seoul National University Bundang Hospital ( Site 0081) | Completed | Seongnam-si | Kyonggi-do | 13620 | South Korea |
| Severance Hospital ( Site 0080) | Completed | Seoul | 03722 | South Korea |
| Samsung Medical Center ( Site 0082) | Completed | Seoul | 06351 | South Korea |
| ICO L Hospitalet ( Site 0090) | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| Hospital Clinic de Barcelona ( Site 0092) | Recruiting | Barcelona | 08008 | Spain |
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| Hospital Universitario Quiron Madrid ( Site 0091) | Recruiting | Madrid | 28223 | Spain |
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| Changhua Christian Hospital ( Site 0181) | Recruiting | Changhua | 50006 | Taiwan |
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| Taipei Medical University Hospital ( Site 0180) | Recruiting | Taipei | 110301 | Taiwan |
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| Chang Gung Medical Foundation-Linkou Branch ( Site 0182) | Recruiting | Taoyuan | 33305 | Taiwan |
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| COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463) | Recruiting | Cherkasy | Cherkasy Oblast | 18009 | Ukraine |
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| Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460) | Recruiting | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
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| ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461) | Recruiting | Rivne | Rivne Oblast | 33010 | Ukraine |
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| Uzhhorod Multispecialty City Clinical Hospital ( Site 0462) | Recruiting | Uzhhorod | Zakarpattia Oblast | 88017 | Ukraine |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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