Ipilimumab for Head and Neck Cancer

Overseen by Rom S Leidner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

R. Bryan Bell, MD, DDS

Principal Investigator

Providence Health & Services

Rom S Leidner, MD

Principal Investigator

Providence Health & Services

Eligibility Criteria

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.

Inclusion Criteria

Patients must have blood test results within protocol-specified parameters

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.

Exclusion Criteria

I have a history of serious digestive system issues.

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.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Intratumoral Ipilimumab Experimental Treatment 1 Intervention

Patients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

Dr. Laurel Soot

Providence Health & Services

Chief Medical Officer since 2024

MD, FACS

Erik Wexler

Providence Health & Services

Chief Executive Officer

Bachelor's degree in Business Administration from the University of Massachusetts Amherst

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania