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Checkpoint Inhibitor

Intratumoral Ipilimumab for Squamous Cell Carcinoma

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-10 days
Awards & highlights

Study 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 below
Select...
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.

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

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.

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,517 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,496 Total Patients Enrolled
R. Bryan Bell, MD, DDSPrincipal 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participants in this particular investigation?

"Affirmative. According to clinicaltrials.gov, this trial is still enrolling patients after commencing on November 18th 2016 and being updated as recently as January 31st 2022. There are only 18 slots available at a single medical centre."

Answered by AI

Are volunteers still welcome to join this clinical research?

"According to clinicaltrials.gov, this trial has been recruiting since November 18th 2016 and was last updated on January 31st 2022."

Answered by AI

What side effects have been reported with Intratumoral Ipilimumab treatments?

"Due to the limited amount of data available, Intratumoral Ipilimumab has been given a safety score of one. It is currently in Phase 1 trials and lacks evidence regarding its efficacy or safety."

Answered by AI

Can you provide insight into any prior research endeavors involving Intratumoral Ipilimumab?

"At present, there are 318 clinical trials investigating the effects of Intratumoral Ipilimumab. 38 of these studies have reached Phase 3 and 20362 medical facilities across the globe are participating in their research. The bulk of sites conducting this scientific analysis is located in Pittsburgh, Pennsylvania."

Answered by AI

In what scenarios is Intratumoral Ipilimumab employed?

"Intratumoral ipilimumab is regularly administered to patients with cutaneous melanoma, yet it may also provide therapeutic benefits for those in need of complete resection, liver carcinoma and metastatic melanoma treatment."

Answered by AI
~2 spots leftby Apr 2025