Ipilimumab for Head and Neck Cancer Patients

Sponsor

Providence Health & Services (Other)

Overall Status

Recruiting

CT.gov ID

NCT02812524

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Arm

83.4

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of the Head and Neck	Drug: Intratumoral Ipilimumab	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intratumoral Ipilimumab in Head and Neck Cancer

Actual Study Start Date :

Nov 18, 2016

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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: Yervoy BMS734016 MDX-010

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:

Yervoy

BMS734016

MDX-010

Outcome Measures

Primary Outcome Measures

Surgery delay [7-10 Days]
The percentage of patients with surgery delayed possibly related to the study drug.

Secondary Outcome Measures

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

Other Outcome Measures

Failure rate of planned laboratory assays [7-10 days]
The percentage of assays achieving a result.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.