Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase I, First-In-Human, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

    Cancer Categories
    • Gastrointestinal (GI)
    Karmanos Trial ID
    • 2019-108
    NCT ID
    • NCT04041310
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I
    Principal Investigator

    Objective:

    Cohort A
    • Primary Objectives
      • To select a Recommended Phase 2 Dose (RP2D) of the GAd20-209-FSP and MVA-209-FSP vaccination regimen based on the overall safety and tolerability of low and high doses in combination with pembrolizumab.
      • To evaluate the overall safety and tolerability of low and high doses of GAd20-209-FSP and MVA-209-FSP vaccination regimen when administered in combination with pembrolizumab.
    • Secondary Objectives
      • To evaluate the neoantigen-specific immunogenicity of low and high doses of the vaccination regimen in combination with pembrolizumab
    Cohort B
    • Primary Objective
      • To evaluate the overall safety and tolerability of the RP2D of GAd20-209-FSP and MVA-209-FSP vaccination regimen in combination with pembrolizumab.
    • Secondary Objective
      • To evaluate the neoantigen-specific immunogenicity of the vaccination regimen at RP2D in combination with pembrolizumab.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266