Clinical Trials /

Ipilimumab for Head and Neck Cancer Patients

NCT02812524

Description:

This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This study will test the feasibility of the administration of intratumoral injections of ipilimumab prior to surgical resection, and the immune system response to treatment.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Ipilimumab for Head and Neck Cancer Patients
  • Official Title: Intratumoral Ipilimumab in Head and Neck Cancer

Clinical Trial IDs

  • ORG STUDY ID: 16-042
  • NCT ID: NCT02812524

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DrugSynonymsArms
Intratumoral IpilimumabYervoy, BMS734016, MDX-010Intratumoral Ipilimumab

Purpose

This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This study will test the feasibility of the administration of intratumoral injections of ipilimumab prior to surgical resection, and the immune system response to treatment.

Detailed Description

      This study will test intratumor microdosing of ipilimumab (antagonistic antibody directed to
      Cytotoxic T-Lmphocyte-Associated Protein 4 [CTLA-4]) 7-10 days prior to planned surgical
      resection of tumor and involved lymph nodes in patients with SCCHN. Tissue, peripheral blood,
      saliva and stool samples will be obtained for immunologic end points. The primary objective
      is to assess safety, as determined by the number of surgeries that are delayed.
    

Trial Arms

NameTypeDescriptionInterventions
Intratumoral IpilimumabExperimentalPatients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.
  • Intratumoral Ipilimumab

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with SCCHN who are planned for surgical resection and in the opinion of the
             surgeon are able to safely undergo tissue biopsy plus intratumoral (IT) injection in
             advance, with special consideration given to risk of occlusion or compression of
             airway or major vessels in the neck, secondary to tumor swelling, or erosion into a
             major vessel in the case of necrosis.

          -  Age 18 years or above with ability to give informed consent, comply with the protocol
             and sign a study-specific consent document. Patients with history of psychiatric
             illness must be judged by the investigator as able to understand the investigational
             nature and risks associated with the therapy.

          -  Any Eastern Cooperative Oncology Group (ECOG) performance status deemed suitable by
             investigator for requirements of study, to potentially include incisional office
             biopsy of lesion, or image guided multiple 18g core needle biopsies (5 minimum) by
             interventional radiology, followed immediately by direct injection of lesion with
             drug.

          -  Patients must have blood test results within protocol-specified parameters

          -  Men must agree to not attempt to become a new father for a total of 165 days
             post-treatment completion

          -  Women must agree not to become pregnant for a total of 105 days post treatment
             completion

        Exclusion Criteria:

          -  Any clinical factors such as bleeding, active infection, colitis history or
             psychiatric factors that in the judgment of the investigator would preclude safe
             participation and compliance with study procedures.

          -  Need for chronic maintenance oral steroids ≥ 20mg prednisone daily equivalent; inhaled
             steroids are acceptable.

          -  History of or current active autoimmune diseases, [e.g. including but not limited to
             inflammatory bowel diseases (IBD), rheumatoid arthritis, autoimmune thyroiditis,
             autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus
             erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barre
             syndrome), which in the judgment of the investigator pose an active and significant
             risk. Vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism
             are not exclusionary.]

          -  Infectious diseases including human immunodeficiency virus (HIV), Hepatitis B virus
             (HBV) and hepatitis C virus (HCV).

          -  Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI
             obstruction and abdominal carcinomatosis which are known risk factors for bowel
             perforation, and in the judgment of the investigator still pose an active risk.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Surgery delay
Time Frame:7-10 Days
Safety Issue:
Description:The percentage of patients with surgery delayed possibly related to the study drug.

Secondary Outcome Measures

Measure:Feasibility of paired tissue sample acquisition
Time Frame:7-10 Days
Safety Issue:
Description:The number of tissue samples that can be collected which were: biopsied, injected, and resected.
Measure:Acceptance of study
Time Frame:28 Days
Safety Issue:
Description:The screening-to-enrollment ratio will be calculated.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Providence Health & Services

Trial Keywords

  • Immunotherapy
  • Yervoy
  • Head and neck cancer
  • Pre-operative

Last Updated