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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
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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for surgery on my head or neck cancer and can safely have a biopsy and treatment injected directly into the tumor.
Select...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-10 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgery delay
Secondary outcome measures
Acceptance of study
Feasibility of paired tissue sample acquisition
Other outcome measures
Failure rate of planned laboratory assays
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intratumoral IpilimumabExperimental Treatment1 Intervention
Patients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.
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Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
119 Previous Clinical Trials
822,569 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,731 Total Patients Enrolled
R. Bryan Bell, MD, DDSPrincipal InvestigatorProvidence Health & Services
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious digestive system issues.I agree not to try to father a child for 165 days after treatment ends.I agree not to become pregnant for 105 days after treatment ends.I don't have conditions like bleeding, infections, colitis, or mental health issues that would make it unsafe for me to join the study.I do not have an active autoimmune or infectious disease like HIV, HBV, or HCV.I am over 18 and can understand and agree to the study's requirements.I understand the risks and investigational nature of the therapy despite my psychiatric history.My doctor thinks I'm fit enough for this study.I take 20mg or more of oral steroids daily for chronic conditions; I may use inhaled steroids.I am scheduled for surgery on my head or neck cancer and can safely have a biopsy and treatment injected directly into the tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Intratumoral Ipilimumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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