Clinical Trials in South Korea / NCT04165798
Recruiting
Observational
KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
NCT04165798 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Carcinoma, Non-Small-Cell Lung
Investigational drug(s) / intervention(s)
Tumor ImagingTumor Tissue CollectionBlood Sample Collection
Tumor Imaging: Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
Tumor Tissue Collection: Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.
Blood Sample Collection: Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)
Study summary
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.
Eligibility
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
* Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has an active autoimmune disease that has required systemic treatment in the 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
Primary outcome measure(s)
- Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% — Up to approximately 1 month
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. - Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC — Up to approximately 1 month
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.
Trial sites (47)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0001) | Gilbert | Arizona | Active Not Recruiting |
| City of Hope ( Site 0014) | Duarte | California | Completed |
| UCSF Medical Center at Mission Bay ( Site 0007) | San Francisco | California | Completed |
| Georgetown University ( Site 0036) | Washington D.C. | District of Columbia | Completed |
| University of Kentucky Markey Cancer Center ( Site 0019) | Lexington | Kentucky | Completed |
| MedStar Franklin Square Medical Center ( Site 0033) | Baltimore | Maryland | Completed |
| Massachusetts General Hospital ( Site 0003) | Boston | Massachusetts | Active Not Recruiting |
| Dana Farber Cancer Institute ( Site 0002) | Boston | Massachusetts | Active Not Recruiting |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) | Omaha | Nebraska | Completed |
| Dartmouth Hitchcock Medical Center ( Site 0016) | Lebanon | New Hampshire | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) | Hackensack | New Jersey | Completed |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034) | New York | New York | Completed |
| Sanford Fargo Medical Center ( Site 0039) | Fargo | North Dakota | Recruiting |
| Cleveland Clinic Main ( Site 0006) | Cleveland | Ohio | Completed |
| Ohio State University Comprehensive Cancer Center ( Site 0015) | Columbus | Ohio | Recruiting |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0010) | Philadelphia | Pennsylvania | Recruiting |
| Sanford Cancer Center ( Site 0038) | Sioux Falls | South Dakota | Recruiting |
| The University of Texas MD Anderson Cancer Center ( Site 0009) | Houston | Texas | Recruiting |
| Petz Aladar Megyei Oktato Korhaz ( Site 0062) | Győr | Győr-Moson-Sopron | Completed |
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) | Szolnok | Jász-Nagykun-Szolnok | Completed |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) | Budapest | Hungary | Completed |
| Soroka Medical Center ( Site 0072) | Beersheba | Israel | Completed |
| Rambam Health Care Campus-Oncology ( Site 0076) | Haifa | Israel | Completed |
| Shaare Zedek Medical Center ( Site 0075) | Jerusalem | Israel | Recruiting |
| Meir Medical Center ( Site 0071) | Kfar Saba | Israel | Completed |
| Rabin Medical Center ( Site 0074) | Petah Tikva | Israel | Completed |
| Chaim Sheba Medical Center ( Site 0070) | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 0077) | Tel Aviv | Israel | Completed |
| Azienda Ospedaliera Universitaria Careggi ( Site 0173) | Florence | Firenze | Completed |
| IRCCS Ospedale San Raffaele ( Site 0171) | Milan | Italy | Completed |
| Policlinico Gemelli di Roma ( Site 0174) | Roma | Italy | Completed |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151) | Warsaw | Masovian Voivodeship | Recruiting |
| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) | Gdansk | Pomeranian Voivodeship | Recruiting |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152) | Koszalin | West Pomeranian Voivodeship | Active Not Recruiting |
| Seoul National University Bundang Hospital ( Site 0081) | Seongnam-si | Kyonggi-do | Completed |
| Severance Hospital ( Site 0080) | Seoul | South Korea | Completed |
| Samsung Medical Center ( Site 0082) | Seoul | South Korea | Completed |
| ICO L Hospitalet ( Site 0090) | L'Hospitalet de Llobregat | Barcelona | Recruiting |
| Hospital Clínic de Barcelona ( Site 0092) | Barcelona | Spain | Recruiting |
| Hospital Universitario Quiron Madrid ( Site 0091) | Madrid | Spain | Recruiting |
+ 7 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in South Korea
Other trials for the same condition
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
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A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04165798 on ClinicalTrials.gov ↗ ← All trials in South Korea