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  • A Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal

    Cancer Categories
    • Gastrointestinal (GI)
    Karmanos Trial ID
    • 2018-122
    NCT ID
    • NCT02314169
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator

    Objective:

    Primary Objectives:
    • To evaluate overall response rate (ORR) with nivolumab in patients with previously treated metastatic squamous cell carcinoma (SCCA) of the anal canal (Part A).
    • To determine an improvement in Progression-Free Survival (PFS) when nivolumab is combined with ipilimumab vs. nivolumab alone in patients with previously treated metastatic SCCA (Part B).
    Secondary Objectives:
    • Part A:
      • To evaluate progression-free survival (PFS) of nivolumab in patients with previously treated metastatic SCCA of the anal canal.
      • To evaluate overall survival (OS) in patients with previously treated metastatic SCCA of the anal canal treated with nivolumab.
      • To evaluate the grade 3 and 4 toxicity rate in patients with previously treated metastatic SCCA of the anal canal when treated with nivolumab.
    • Part B:
      • To evaluate the overall response rate (ORR) of nivolumab plus or minus ipilimumab in patients with previously treated metastatic SCCA of the anal canal.
      • To evaluate overall survival (OS) in patients with previously treated metastatic SCCA of the anal canal treated with nivolumab plus or minus ipilimumab.
      • To evaluate the grade 3 and 4 toxicity rate in patients with previously treated metastatic SCCA of the anal canal when treated with nivolumab plus or minus ipilimumab.
  • 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