RecruitingNCT04165798

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)

KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

1,065 participants

Start Date

Dec 19, 2019

Study Type

OBSERVATIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is the main umbrella study overseeing multiple sub-studies testing experimental drugs in combination with pembrolizumab (Keytruda) — an immunotherapy drug — for patients with advanced (stage IV) non-small cell lung cancer (NSCLC). Different combinations and substudies are ongoing under this master protocol, and patients are enrolled into specific sub-trials based on their tumor characteristics. **You may be eligible if...** - You have confirmed stage IV non-small cell lung cancer (squamous or non-squamous) - Your cancer is measurable on imaging **You may NOT be eligible if...** - You have an active autoimmune disease that required systemic treatment in the past 2 years - You have had lung inflammation (pneumonitis or interstitial lung disease) that required steroids - You have an active infection requiring systemic therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTumor Imaging

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

PROCEDURETumor Tissue Collection

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

PROCEDUREBlood Sample Collection

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

Locations(47)

Banner MD Anderson Cancer Center ( Site 0001)

Gilbert, Arizona, United States

City of Hope ( Site 0014)

Duarte, California, United States

UCSF Medical Center at Mission Bay ( Site 0007)

San Francisco, California, United States

Georgetown University ( Site 0036)

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

University of Kentucky Markey Cancer Center ( Site 0019)

Lexington, Kentucky, United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 0003)

Boston, Massachusetts, United States

Dana Farber Cancer Institute ( Site 0002)

Boston, Massachusetts, United States

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

Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center ( Site 0016)

Lebanon, New Hampshire, United States

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

Hackensack, New Jersey, United States

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

New York, New York, United States

Sanford Fargo Medical Center ( Site 0039)

Fargo, North Dakota, United States

Cleveland Clinic Main ( Site 0006)

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center ( Site 0015)

Columbus, Ohio, United States

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

Philadelphia, Pennsylvania, United States

Sanford Cancer Center ( Site 0038)

Sioux Falls, South Dakota, United States

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

Houston, Texas, United States

Petz Aladar Megyei Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, Hungary

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

Szolnok, Jász-Nagykun-Szolnok, Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

Budapest, Hungary

Soroka Medical Center ( Site 0072)

Beersheba, Israel

Rambam Health Care Campus-Oncology ( Site 0076)

Haifa, Israel

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, Israel

Meir Medical Center ( Site 0071)

Kfar Saba, Israel

Rabin Medical Center ( Site 0074)

Petah Tikva, Israel

Chaim Sheba Medical Center ( Site 0070)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0077)

Tel Aviv, Israel

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Firenze, Italy

IRCCS Ospedale San Raffaele ( Site 0171)

Milan, Italy

Policlinico Gemelli di Roma ( Site 0174)

Roma, Italy

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

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

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

Koszalin, West Pomeranian Voivodeship, Poland

Seoul National University Bundang Hospital ( Site 0081)

Seongnam-si, Kyonggi-do, South Korea

Severance Hospital ( Site 0080)

Seoul, South Korea

Samsung Medical Center ( Site 0082)

Seoul, South Korea

ICO L Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Clínic de Barcelona ( Site 0092)

Barcelona, Spain

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, Spain

Changhua Christian Hospital ( Site 0181)

Changhua, Taiwan

Taipei Medical University Hospital ( Site 0180)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

Taoyuan, Taiwan

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

Cherkasy, Cherkasy Oblast, Ukraine

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

Rivne, Rivne Oblast, Ukraine

Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

Uzhhorod, Zakarpattia Oblast, Ukraine

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NCT04165798