RECRUITING

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)

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Conditions

Carcinoma, Non-Small-Cell LungProgrammed Cell Death-1 (PD1, PD-1)Programmed Death-Ligand 1 (PDL1, PD-L1)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2019-12-19
Study Completion:2032-02-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04165798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
  2. * Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
  1. * Has an active autoimmune disease that has required systemic treatment in the past 2 years
  2. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  3. * Has an active infection requiring systemic therapy

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Banner MD Anderson Cancer Center ( Site 0001)
Gilbert, Arizona, 85234
United States
City of Hope ( Site 0014)
Duarte, California, 91010
United States
UCSF Medical Center at Mission Bay ( Site 0007)
San Francisco, California, 94158
United States
Georgetown University ( Site 0036)
Washington D.C., District of Columbia, 20007
United States
University of Kentucky Markey Cancer Center ( Site 0019)
Lexington, Kentucky, 40536-0293
United States
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, 21237
United States
Massachusetts General Hospital ( Site 0003)
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute ( Site 0002)
Boston, Massachusetts, 02215
United States
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
Omaha, Nebraska, 68130
United States
Dartmouth Hitchcock Medical Center ( Site 0016)
Lebanon, New Hampshire, 03766
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
Hackensack, New Jersey, 07601
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)
New York, New York, 10016
United States
Sanford Fargo Medical Center ( Site 0039)
Fargo, North Dakota, 58102
United States
Cleveland Clinic Main ( Site 0006)
Cleveland, Ohio, 44195
United States
Ohio State University Comprehensive Cancer Center ( Site 0015)
Columbus, Ohio, 43210
United States
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
Philadelphia, Pennsylvania, 19104
United States
Sanford Cancer Center ( Site 0038)
Sioux Falls, South Dakota, 57104
United States
The University of Texas MD Anderson Cancer Center ( Site 0009)
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-19
Study Completion Date2032-02-13

Study Record Updates

Study Start Date2019-12-19
Study Completion Date2032-02-13

Terms related to this study

Keywords Provided by Researchers

  • Programmed Cell Death-1 (PD1, PD-1)
  • Programmed Death-Ligand 1 (PDL1, PD-L1)

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung