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

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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. With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.

Key facts

Study ID

NCT03302234

Run by

Merck Sharp & Dohme LLC

People needed

568

Starts

2017-12-14

Expected to finish

2022-09-07

Last updated by the study team

2023-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a histologically or cytologically confirmed diagnosis of Stage IV metastatic non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer version 8)
• Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by investigator
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Has a life expectancy of at least 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 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

You may not qualify if…

• 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), anti-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 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 c-ros oncogene 1 (ROS1) mutation

Where it is running

• Disney Family Cancer Center ( Site 0035) — Burbank, California, United States
• Pacific Cancer Care ( Site 0001) — Monterey, California, United States
• John Wayne Cancer Institute ( Site 0021) — Santa Monica, California, United States
• Florida Hospital Cancer Institute ( Site 0009) — Orlando, Florida, United States
• Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018) — Paducah, Kentucky, United States
• New England Cancer Specialists ( Site 0019) — Scarborough, Maine, United States
• Boston Medical Center ( Site 0025) — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center ( Site 0020) — Burlington, Massachusetts, United States
• Holy Name Medical Center ( Site 0022) — Teaneck, New Jersey, United States
• Icahn School of Medicine at Mount Sinai ( Site 0034) — New York, New York, United States
• The Ohio State University Wexner Medical Center ( Site 0016) — Columbus, Ohio, United States
• Mid Ohio Oncology/Hematology Inc. ( Site 0003) — Columbus, Ohio, United States
• Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031) — Portland, Oregon, United States
• Greenville Health System ( Site 8010) — Greenville, South Carolina, United States
• University of Tennessee Erlanger Oncology & Hematology ( Site 0026) — Chattanooga, Tennessee, United States
• Tennessee Cancer Specialists ( Site 0017) — Knoxville, Tennessee, United States
• Texas Oncology-Arlington South ( Site 8006) — Arlington, Texas, United States
• Texas Oncology-Methodist Dallas Cancer Center ( Site 8000) — Dallas, Texas, United States
• Texas Oncology-Flower Mound ( Site 8007) — Flower Mound, Texas, United States
• Texas Oncology-Longview Cancer Center ( Site 8009) — Longview, Texas, United States
• Northwest Cancer Specialists, P.C. ( Site 8001) — Vancouver, Washington, United States
• Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033) — Yakima, Washington, United States
• University of Wisconsin Carbone Cancer Center ( Site 0004) — Madison, Wisconsin, United States
• Medical College of Wisconsin Clinical Cancer Center ( Site 0027) — Milwaukee, Wisconsin, United States
• Mayo Clinic Cancer Center ( Site 0007) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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