Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-small Cell Lung Cancer (MK-3475-598/KEYNOTE-598)



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:December 14, 2017
End Date:February 22, 2024
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)

The purpose of this study is to determine the efficacy of pembrolizumab given in combination
with either ipilimumab or placebo as first-line treatment in participants with metastatic
non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall
survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive
pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.


Inclusion Criteria:

- Has a histologically or cytologically confirmed diagnosis of Stage IV metastatic NSCLC
(American Joint Committee on Cancer version 8)

- Has measurable disease per RECIST 1.1 as determined by investigator

- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Has a life expectancy of >3 months

- Has provided archival tumor tissue sample or newly obtained core or excisional biopsy
of a tumor lesion not previously irradiated

- Female participants of childbearing potential must have a negative serum pregnancy
test within 72 hours prior to receiving the first dose of study therapy

- Female and male participants of reproductive potential must agree to use contraception
starting from the first dose of study medication, throughout the study period, and for
up to 120 days after the last dose of study medication

- Male participants must refrain from donating sperm starting from the first dose of
study medication, throughout the study period, and for up to 120 days after the last
dose of study medication

Exclusion Criteria:

- Has received prior systemic chemotherapy/other targeted or biological antineoplastic
therapy treatment for their Stage IV metastatic NSCLC

- Has a tumor that harbors an epidermal growth factor receptor (EGFR)-sensitizing
(activating) mutation or an anaplastic lymphoma kinase (ALK) translocation

- Is currently participating in or has participated in a trial of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study therapy

- Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1),
Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti- Programmed Cell Death
Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or
co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4
[CTLA-4], OX-40, CD137)

- Has received prior radiotherapy within 2 weeks of start of study therapy or received
lung radiation therapy of >30 Gray (Gy) within 6 months of the first dose of study
therapy

- Has recovered from all radiation-related toxicities, does not require corticosteroids,
and has not had radiation pneumonitis

- Is receiving systemic steroid therapy ≤7 days prior to the first dose of study therapy
or receiving any other form of immunosuppressive medication

- Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years with the exception of curatively treated basal cell carcinoma
of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ
cancers

- Has known untreated central nervous system (CNS) metastases and/or carcinomatous
meningitis

- Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive
drugs)

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(i.e., doses exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study therapy

- Has a history of (non-infectious) pneumonitis that required systemic steroids or
current pneumonitis/interstitial lung disease

- Has had an allogeneic tissue/solid organ transplant

- Has received a live vaccine within 30 days prior to the first dose of study therapy

- Has an active infection requiring systemic therapy

- Has a known history of human immunodeficiency virus (HIV) infection

- Has a known history of hepatitis B or known active hepatitis C virus infection

- Has a known history of active tuberculosis

- Has known psychiatric or substance abuse disorders that would interfere with
cooperating with the requirements of the trial

- Is a regular user of any illicit drugs or had a recent history of substance abuse

- Is pregnant or breast feeding or expecting to conceive or father starting from the
first dose of study medication, throughout the study period, and for up to 120 days
after the last dose of study medication

- Has severe hypersensitivity to pembrolizumab and/or any of its excipients and/or to
ipilimumab and/or any of its excipients

- Has a ROS1 translocation
We found this trial at
26
sites
Burlington, Massachusetts 01805
Phone: 781-744-2815
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
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Arlington, Texas 76014
Phone: 281-863-4631
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Boston, Massachusetts 02118
Phone: 617-638-5631
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Burbank, California 91505
Phone: 818-748-4778
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Chattanooga, Tennessee 37403
Phone: 423-778-2167
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-366-1554
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, Ohio
Phone: 614-383-6236
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Dallas, Texas 75203
Phone: 281-863-4631
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Flower Mound, Texas 75028
Phone: 916-533-0052
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Greenville, South Carolina 29615
Phone: 281-863-4631
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Knoxville, Tennessee 37920
Phone: 865-934-2670
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Longview, Texas 75601
Phone: 281-863-4631
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-263-9063
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Milwaukee, Wisconsin 53226
Phone: 414-805-8900
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Monterey, California 93940
Phone: 831-375-4105
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: 212-824-8580
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Orlando, Florida 32804
Phone: 407-303-3235
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Paducah, Kentucky 42003
Phone: 270-441-4343
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Phoenix, Arizona 85054
Phone: 855-776-0015
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Portland, Oregon 97213
Phone: 503-215-2614
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860 Boulevard Oroño
Rosario, Santa Fe 2000
Phone: +543414200250
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Scarborough, Maine 04074
Phone: 207-396-7600
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Teaneck, New Jersey 07666
Phone: 201-833-5618
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Vancouver, Washington 98684
Phone: 281-863-4631
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Yakima, Washington 98902
Phone: 509-574-3494
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