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Checkpoint Inhibitor

Ipilimumab for Head and Neck Cancer

Phase 1
Waitlist Available
Led By R. Bryan Bell, MD, DDS
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with SCCHN planned for surgical resection and deemed able to safely undergo tissue biopsy plus intratumoral (IT) injection
Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document
Must not have
History of acute diverticulitis, intra-abdominal abscess, GI obstruction, and abdominal carcinomatosis known as risk factors for bowel perforation
History of or current active autoimmune diseases, infectious diseases including HIV, HBV, and HCV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-10 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with squamous cell carcinoma of the head and neck. It will test if it's possible to give ipilimumab, a cancer treatment, before surgery. The goal is to see if the patient's immune system responds to the treatment.

Who is the study for?
This trial is for adults with head and neck squamous cell carcinoma who are scheduled for surgery. They must be able to undergo a biopsy, handle the treatment, and sign consent. Men and women must agree to avoid pregnancy post-treatment. Excluded are those with certain infections, need high-dose steroids, have active autoimmune diseases or conditions that increase bowel perforation risk.
What is being tested?
The study tests intratumoral injections of Ipilimumab in patients before they have surgery to remove their cancer. It aims to see if this method is doable and how the immune system responds.
What are the potential side effects?
Ipilimumab can cause side effects like inflammation in different body parts, allergic reactions during infusion into the tumor, tiredness, digestive problems such as diarrhea or colitis (inflammation of the inner lining of the colon), skin rash, hormone gland problems (like thyroid dysfunction), and liver inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery on my head or neck cancer and can safely have a biopsy and treatment injected directly into the tumor.
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I am over 18 and can understand and agree to the study's requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of serious digestive system issues.
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I do not have an active autoimmune or infectious disease like HIV, HBV, or HCV.
Select...
I take 20mg or more of oral steroids daily for chronic conditions; I may use inhaled steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgery delay
Secondary study objectives
Acceptance of study
Feasibility of paired tissue sample acquisition
Other study objectives
Failure rate of planned laboratory assays

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intratumoral IpilimumabExperimental Treatment1 Intervention
Patients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
124 Previous Clinical Trials
823,745 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,053 Total Patients Enrolled
R. Bryan Bell, MD, DDSPrincipal InvestigatorProvidence Health & Services
Rom S Leidner, MDPrincipal InvestigatorProvidence Health & Services

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02812524 — Phase 1
Squamous Cell Carcinoma Research Study Groups: Intratumoral Ipilimumab
Squamous Cell Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02812524 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02812524 — Phase 1
~2 spots leftby Dec 2025
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