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 now
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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.
Key facts
- Study ID
- NCT04165798
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 1065
- Starts
- 2019-12-19
- Expected to finish
- 2032-02-13
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Shaare Zedek Medical Center ( Site 0075) — Jerusalem, Israel (enrolling)
- The University of Texas MD Anderson Cancer Center ( Site 0009) — Houston, Texas, United States (enrolling)
- Sanford Fargo Medical Center ( Site 0039) — Fargo, North Dakota, United States (enrolling)
- Chaim Sheba Medical Center ( Site 0070) — Ramat Gan, Israel (enrolling)
- Dartmouth Hitchcock Medical Center ( Site 0016) — Lebanon, New Hampshire, United States (enrolling)
- Ohio State University Comprehensive Cancer Center ( Site 0015) — Columbus, Ohio, United States (enrolling)
- Abramson Cancer Center of the University of Pennsylvania ( Site 0010) — Philadelphia, Pennsylvania, United States (enrolling)
- Hospital Clinic de Barcelona ( Site 0092) — Barcelona, Spain (enrolling)
- Sanford Cancer Center ( Site 0038) — Sioux Falls, South Dakota, United States (enrolling)
- Changhua Christian Hospital ( Site 0181) — Changhua, Taiwan (enrolling)
- Taipei Medical University Hospital ( Site 0180) — Taipei, Taiwan (enrolling)
- Chang Gung Medical Foundation-Linkou Branch ( Site 0182) — Taoyuan, Taiwan (enrolling)
- COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463) — Cherkasy, Cherkasy Oblast, Ukraine (enrolling)
- Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460) — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine (enrolling)
- ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461) — Rivne, Rivne Oblast, Ukraine (enrolling)
- Uzhhorod Multispecialty City Clinical Hospital ( Site 0462) — Uzhhorod, Zakarpattia Oblast, Ukraine (enrolling)
- Rambam Health Care Campus-Oncology ( Site 0076) — Haifa, Israel
- Meir Medical Center ( Site 0071) — Kfar Saba, Israel
- Rabin Medical Center ( Site 0074) — Petah Tikva, Israel
- Sourasky Medical Center ( Site 0077) — Tel Aviv, Israel
- Banner MD Anderson Cancer Center ( Site 0001) — Gilbert, Arizona, United States
- 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
Full record on ClinicalTrials.gov
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