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)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04165798
Status
Recruiting
Apply to this trial

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tumor Imaging — DIAGNOSTIC_TEST
    Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
  • Tumor Tissue Collection — PROCEDURE
    Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.
  • 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)

Study Details

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 Dates

Start date
Dec 19, 2019
Status verified
May 2026
Primary completion
Feb 13, 2032
Completion
Feb 13, 2032

Study Design

Enrollment
1,065 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% [ Time Frame: Up to approximately 1 month ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Center ( Site 0001)GilbertArizona85234-
City of Hope ( Site 0014)DuarteCalifornia91010-
UCSF Medical Center at Mission Bay ( Site 0007)San FranciscoCalifornia94158-
Georgetown University ( Site 0036)Washington D.C.District of Columbia20007-
University of Kentucky Markey Cancer Center ( Site 0019)LexingtonKentucky40536-0293-
MedStar Franklin Square Medical Center ( Site 0033)BaltimoreMaryland21237-
Dana Farber Cancer Institute ( Site 0002)BostonMassachusetts02215-
Massachusetts General Hospital ( Site 0003)BostonMassachusetts02114-
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)OmahaNebraska68130-
Dartmouth Hitchcock Medical Center ( Site 0016)LebanonNew Hampshire03766
Study Coordinator
603-650-4428
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)HackensackNew Jersey07601-
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)New YorkNew York10016-
Sanford Fargo Medical Center ( Site 0039)FargoNorth Dakota58102
Study Coordinator
701-234-2000
Cleveland Clinic Main ( Site 0006)ClevelandOhio44195-
Ohio State University Comprehensive Cancer Center ( Site 0015)ColumbusOhio43210
Study Coordinator
614-366-0233
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)PhiladelphiaPennsylvania19104
Study Coordinator
215-220-9703
Sanford Cancer Center ( Site 0038)Sioux FallsSouth Dakota57104
Study Coordinator
605-328-8000
The University of Texas MD Anderson Cancer Center ( Site 0009)HoustonTexas77030
Study Coordinator
713-792-6363

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZCity of Hope· Duarte, CAUCSF Medical Center at Mission Bay· San Francisco, CAGeorgetown University· Washington D.C., DCUniversity of Kentucky Markey Cancer Center· Lexington, KYMedStar Franklin Square Medical Center· Baltimore, MD

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