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Protocol No. UW17103

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

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

Objective The purpose of this study is to test the effectiveness and safety of the combination of research study drugs, pembrolizumab + ipilimumab, compared to pembrolizumab alone. The study will also test the effectiveness of the research study drug compared to placebo (look-alike with no active ingredients). Pembrolizumab (KEYTRUDA®) and Ipilimumab (Yervoy®) have both been approved by the US Food and Drug Administration (FDA) for the treatment of the disease you have, but the use of these drugs in combination is investigational and can only be given in a research study

Treatment You will be put into a group by chance, similar to flipping a coin, in order to decide what type of study drug you will receive:
  • Group 1: pembrolizumab + ipilimumab
  • Group 2: pembrolizumab + placebo (a look-alike with no active ingredients).
    Pembrolizumab (200mg) will be administered intravenously every 3 weeks, and each infusion will take about 30 minutes. Ipilimumab or placebo (1mg/kg) will be administered intravenously every 6 weeks, and each infusion will take about 90 minutes.
    You have a 50% chance of receiving pembrolizumab + ipilimumab and a 50% chance of receiving pembrolizumab + placebo.
    Neither you nor the study doctor will know what you are receiving. In case of a health emergency, the study doctor can get this information.

  • Description This is 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%)

    Key Eligibility
  • Must have histologically or cytologically confirmed diagnosis of Stage IV metastatic NSCLC
  • Have measurable disease per RECIST 1.1
  • ECOG Performance Status of 0 or 1
  • Have adequate hematological, renal, hepatic and coagulation organ function
  • Tumor demonstrates PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as assessed by IHC as determined by an FDA-approved test (22C3 Pharm IHC PharmDx [Dako] assay) at a central laboratory
  • Female subjects of childbearing potential must have a negative serum pregnancy test
  • Male and Female patients of child-bearing potential must use adequate contraceptive during the treatment and for at least 120 days after the last dose of study medication
  • No prior systemic chemotherapy/other targeted or biological antineoplastic therapy treatment for their Stage IV metastatic NSCLC
  • Tumor can not harbor an EGFR-sensitizing (activating) mutation or an ALK translocation
  • No prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
  • No prior radiotherapy within 2 weeks of start of trial treatment or received lung radiation therapy of >30 Gy within 6 months of the first dose of trial treatment
  • Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
  • No systemic steroid therapy ≤7 days prior to the first dose of trial treatment and can not be receiving any other form of immunosuppressive medication
  • No untreated CNS metastases and/or carcinomatous meningitis
  • No active autoimmune disease that has required systemic treatment in past 2 years
  • No prior allogeneic tissue/solid organ transplant
  • No known HIV, hepatitis B or active hepatitis C
  • No known history of active tuberculosis

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics