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 | Recruiting FDA Drug

• 3 other identifiers: 3475-U01MK-3475-U01KEYMAKER-U01
• Study Type: observational
• Target: 1,065
• Locations: 9 countries
• Sites: 47

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Diagnostic Test: Tumor Imaging; Procedure: Tumor Tissue Collection; Procedure: Blood Sample Collection

Interventions

Blood Sample Collection PROCEDURE

Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)

Prospective NSCLC Participants

Tumor Imaging DIAGNOSTIC_TEST

Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.

Prospective NSCLC Participants

Tumor Tissue Collection PROCEDURE

Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.

Prospective NSCLC Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (47)

Banner MD Anderson Cancer Center ( Site 0001)

Gilbert, Arizona, 85234, United States

COMPLETED

City of Hope ( Site 0014)

Duarte, California, 91010, United States

COMPLETED

UCSF Medical Center at Mission Bay ( Site 0007)

San Francisco, California, 94158, United States

COMPLETED

Georgetown University ( Site 0036)

Washington D.C., District of Columbia, 20007, United States

COMPLETED

University of Kentucky Markey Cancer Center ( Site 0019)

Lexington, Kentucky, 40536-0293, United States

COMPLETED

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, 21237, United States

COMPLETED

Massachusetts General Hospital ( Site 0003)

Boston, Massachusetts, 02114, United States

COMPLETED

Dana Farber Cancer Institute ( Site 0002)

Boston, Massachusetts, 02215, United States

COMPLETED

Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

Omaha, Nebraska, 68130, United States

COMPLETED

Dartmouth Hitchcock Medical Center ( Site 0016)

Lebanon, New Hampshire, 03766, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

Hackensack, New Jersey, 07601, United States

COMPLETED

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)

New York, New York, 10016, United States

COMPLETED

Sanford Fargo Medical Center ( Site 0039)

Fargo, North Dakota, 58102, United States

RECRUITING

Cleveland Clinic Main ( Site 0006)

Cleveland, Ohio, 44195, United States

COMPLETED

Ohio State University Comprehensive Cancer Center ( Site 0015)

Columbus, Ohio, 43210, United States

RECRUITING

Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Sanford Cancer Center ( Site 0038)

Sioux Falls, South Dakota, 57104, United States

RECRUITING

The University of Texas MD Anderson Cancer Center ( Site 0009)

Houston, Texas, 77030, United States

RECRUITING

Petz Aladar Megyei Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, 9024, Hungary

COMPLETED

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

COMPLETED

Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

Budapest, 1121, Hungary

COMPLETED

Soroka Medical Center ( Site 0072)

Beersheba, 8457108, Israel

COMPLETED

Rambam Health Care Campus-Oncology ( Site 0076)

Haifa, 3109601, Israel

COMPLETED

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, 9103102, Israel

RECRUITING

Meir Medical Center ( Site 0071)

Kfar Saba, 4428132, Israel

COMPLETED

Rabin Medical Center ( Site 0074)

Petah Tikva, 4941492, Israel

COMPLETED

Chaim Sheba Medical Center ( Site 0070)

Ramat Gan, 5262000, Israel

RECRUITING

Sourasky Medical Center ( Site 0077)

Tel Aviv, 6423906, Israel

COMPLETED

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Firenze, 50134, Italy

COMPLETED

IRCCS Ospedale San Raffaele ( Site 0171)

Milan, 20132, Italy

COMPLETED

Policlinico Gemelli di Roma ( Site 0174)

Roma, 00168, Italy

COMPLETED

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Pomeranian Voivodeship, 80-952, Poland

COMPLETED

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

ACTIVE NOT RECRUITING

Seoul National University Bundang Hospital ( Site 0081)

Seongnam-si, Kyonggi-do, 13620, South Korea

COMPLETED

Severance Hospital ( Site 0080)

Seoul, 03722, South Korea

COMPLETED

Samsung Medical Center ( Site 0082)

Seoul, 06351, South Korea

COMPLETED

ICO L Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Clínic de Barcelona ( Site 0092)

Barcelona, 08008, Spain

RECRUITING

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, 28223, Spain

RECRUITING

Changhua Christian Hospital ( Site 0181)

Changhua, 50006, Taiwan

RECRUITING

Taipei Medical University Hospital ( Site 0180)

Taipei, 110301, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

Taoyuan District, 33305, Taiwan

RECRUITING

COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

RECRUITING

Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

Rivne, Rivne Oblast, 33010, Ukraine

RECRUITING

Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

RECRUITING

Related Links

• Merck Clinical Trials Information

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: December 19, 2019
• Primary Completion (Estimated): February 13, 2032
• Study Completion (Estimated): February 13, 2032
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); KR (3); ES (3); UA (4); IL (7); US (18); TW (3); HU (3); PL (3)