NCT02812524

Ipilimumab for Head and Neck Cancer Patients

Intratumoral Ipilimumab in Head and Neck Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will test intratumor microdosing of ipilimumab (antagonistic antibody directed to Cytotoxic T-Lmphocyte-Associated Protein 4 \[CTLA-4\]) 7-10 days prior to planned surgical resection of tumor and involved lymph nodes in patients with SCCHN. Tissue, peripheral blood, saliva and stool samples will be obtained for immunologic end points. The primary objective is to assess safety, as determined by the number of surgeries that are delayed.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Intratumoral Ipilimumab	Patients with a planned resection of SCCHN will have a biopsy procedure 7-10 days prior to surgery and receive an injection of ipilimumab directly into a tumor.

Timeline

• Start date: 2016-11-18
• Primary completion: 2019-09-21
• Completion: 2025-12-01
• First posted: 2016-06-24
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study