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, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumors (MAST)

    Cancer Categories
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung
    Karmanos Trial ID
    • 2021-071
    NCT ID
    • NCT05346484
    Age Group
    • Adult
    • 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
    • Hirva
      Mamdani, M.D.

      Lung Cancer Screening, Oncology - Medical View Profile



    • To evaluate safety of IV and IT CF33-hNIS in monotherapy and in combination with pembrolizumab.  To determine Recommended Phase 2 Dose (RP2D) of CF33-hNIS in monotherapy and in combination with pembrolizumab.


    • Anti-tumor activity of CF33-hNIS administered as a monotherapy and in combination with pembrolizumab based on objective response rate (ORR) using RECIST v1.1 (Seymour et al., 2017) and immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0
    • Efficacy of IT and IV CF33-hNIS administered as a monotherapy and in combination with pembrolizumab:
      a. Progression-free survival (PFS)
      b. Overall survival (OS)
      c. Duration of Response (DOR)
      d. Disease Control Rate (DCR)
    • Viral titers of CF33-hNIS
    • Infection of tumors with CF33-hNIS
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

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