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)
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)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center ( Site 0001) — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
- Tumor Imaging (DIAGNOSTIC_TEST)
- Tumor Tissue Collection (PROCEDURE)
- Blood Sample Collection (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (47 Sites)
Showing the first 25 of 47 sites.
- Banner MD Anderson Cancer Center ( Site 0001) — Gilbert, Arizona
- City of Hope ( Site 0014) — Duarte, California
- UCSF Medical Center at Mission Bay ( Site 0007) — San Francisco, California
- Georgetown University ( Site 0036) — Washington D.C., District of Columbia
- University of Kentucky Markey Cancer Center ( Site 0019) — Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033) — Baltimore, Maryland
- Massachusetts General Hospital ( Site 0003) — Boston, Massachusetts
- Dana Farber Cancer Institute ( Site 0002) — Boston, Massachusetts
- Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) — Omaha, Nebraska
- Dartmouth Hitchcock Medical Center ( Site 0016) — Lebanon, New Hampshire
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) — Hackensack, New Jersey
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034) — New York, New York
- Sanford Fargo Medical Center ( Site 0039) — Fargo, North Dakota
- Cleveland Clinic Main ( Site 0006) — Cleveland, Ohio
- Ohio State University Comprehensive Cancer Center ( Site 0015) — Columbus, Ohio
- Abramson Cancer Center of the University of Pennsylvania ( Site 0010) — Philadelphia, Pennsylvania
- Sanford Cancer Center ( Site 0038) — Sioux Falls, South Dakota
- The University of Texas MD Anderson Cancer Center ( Site 0009) — Houston, Texas
- Petz Aladar Megyei Oktato Korhaz ( Site 0062) — Győr, Győr-Moson-Sopron
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) — Szolnok, Jász-Nagykun-Szolnok
- Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) — Budapest,
- Soroka Medical Center ( Site 0072) — Beersheba,
- Rambam Health Care Campus-Oncology ( Site 0076) — Haifa,
- Shaare Zedek Medical Center ( Site 0075) — Jerusalem,
- Meir Medical Center ( Site 0071) — Kfar Saba,
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.