Can injecting immunotherapy directly into tumors boost the body's fight against head and neck cancer?
NCT ID NCT02812524
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for 18 adults with head and neck cancer who are already scheduled for surgery. Researchers want to see if it is safe and possible to inject the drug ipilimumab directly into the tumor a few weeks before the operation. The main goal is to check if this approach delays surgery and to learn how the immune system responds.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
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Nov 2016
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Portland Providence Medical Center
Portland, Oregon, 97213, United States
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Other studies related to the condition(s) this trial covers.
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