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)
Recruiting · NCT04165798 · Observational (researchers observe without assigning treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
Blood Sample CollectionTumor ImagingTumor Tissue Collection
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
47 locations listed across 15 US states.
- 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
- Hospital Clínic de Barcelona ( Site 0092) - Barcelona, Spain
- Soroka Medical Center ( Site 0072) - Beersheba, Israel
- Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) - Budapest, Hungary
- Changhua Christian Hospital ( Site 0181) - Changhua, Taiwan
- 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
- Hospital Universitario Quiron Madrid ( Site 0091) - Madrid, Spain
- IRCCS Ospedale San Raffaele ( Site 0171) - Milan, Italy
- Rabin Medical Center ( Site 0074) - Petah Tikva, Israel
- Chaim Sheba Medical Center ( Site 0070) - Ramat Gan, Israel
- Policlinico Gemelli di Roma ( Site 0174) - Roma, Italy
- Severance Hospital ( Site 0080) - Seoul, South Korea
- Samsung Medical Center ( Site 0082) - Seoul, South Korea
- Taipei Medical University Hospital ( Site 0180) - Taipei, Taiwan
- Chang Gung Medical Foundation-Linkou Branch ( Site 0182) - Taoyuan, Taiwan
- Sourasky Medical Center ( Site 0077) - Tel Aviv, Israel
- ICO L Hospitalet ( Site 0090) - L'Hospitalet de Llobregat, Barcelona, Spain
- COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463) - Cherkasy, Cherkasy Oblast, Ukraine
- Azienda Ospedaliera Universitaria Careggi ( Site 0173) - Florence, Firenze, Italy
- Petz Aladar Megyei Oktato Korhaz ( Site 0062) - Győr, Győr-Moson-Sopron, Hungary
- Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460) - Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) - Szolnok, Jász-Nagykun-Szolnok, Hungary
- Seoul National University Bundang Hospital ( Site 0081) - Seongnam-si, Kyonggi-do, South Korea
- 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
- ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461) - Rivne, Rivne Oblast, Ukraine
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152) - Koszalin, West Pomeranian Voivodeship, Poland
- Uzhhorod Multispecialty City Clinical Hospital ( Site 0462) - Uzhhorod, Zakarpattia Oblast, Ukraine