Print Friendly Page

Protocol No. NCI9673

Principal Investigator Deming, Dustin

Phase II

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title A Multi-Institutional Phase 2 Study of Nivolumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal

Objective The purpose of this study is to test any good and bad effects of nivolumab alone and nivolumab in combination with ipilimumab. Nivolumab or the combination of nivolumab and ipilimumab could shrink your cancer but it could also cause side effects

Treatment
Nivolumab will be given intravenously every four weeks at a dose of at a flat dose of 480 mg IV over 30 minutes OR
Nivolumab will be given intravenously every four weeks at a dose of at a flat dose of 480 mg IV over 30 minutes PLUS ipilimumab will be administered IV over 30 minutes at 1 mg/kg every 8 weeks

Description Phase 2 Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal

Key Eligibility
  • Must have histologically or cytologically confirmed previously treated metastatic squamous cell carcinoma of the anal canal
  • Must have measurable disease according to the standard RECIST version 1.1
  • Must be 18 years of age orolder
  • ECOG performance status 0-1 or Karnofsky greater than or equal to 80%
  • Must have normal organ and marrow function as defined by the protocol
  • Can not be pregnant or breastfeeding
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and have been stable for at least three months prior to registration, and eligible subjects should be neurologically asymptomatic
  • Willingness for evaluation of cardiac function including EKG and ECHO cardiogram for any patients with a history of CHF or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs as clinically indicated
  • Must be willing to undergo testing for HIV
  • Must be willing to be tested for Hepatitis screening
    EXCLUSION
  • No prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • No prior history of severe hypersensitivity reaction to any monoclonal antibody
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater)

  • Applicable Disease Sites Anal

    Status Open

    Participating Institutions UW Hospital and Clinics