Ipilimumab for Head and Neck Cancer Patients

Intratumoral Ipilimumab in Head and Neck Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Intervention / Treatment: Drug: Intratumoral Ipilimumab

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97213
      • Portland Providence Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intratumoral Ipilimumab; Patients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.	Drug: Intratumoral Ipilimumab; Patients with a planned resection of SCCHN will have a biopsy procedure 7-10 days prior to surgery and receive an injection of ipilimumab directly into a tumor.; Other Names: MDX-010; Yervoy; BMS734016

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate of planned laboratory assays	The percentage of assays achieving a result.	7-10 days

Collaborators and Investigators

• Sponsor: Providence Health & Services
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Rom S Leidner, MD, Providence Health & Services; Principal Investigator: R. Bryan Bell, MD, DDS, Providence Health & Services

Publications and helpful links

Helpful Links

• Providence Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2016
• Primary Completion (Actual): September 21, 2019
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimated): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Head and neck cancer; Yervoy; Pre-operative
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ipilimumab
• Other Study ID Numbers: 16-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No