NCT02812524

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
6mo left

Started Nov 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Nov 2016Dec 2026

First Submitted

Initial submission to the registry

June 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 18, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2019

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

June 14, 2016

Last Update Submit

April 21, 2026

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

ImmunotherapyYervoyHead and neck cancerPre-operative

Outcome Measures

Primary Outcomes (1)

  • Surgery delay

    The percentage of patients with surgery delayed possibly related to the study drug.

    7-10 Days

Secondary Outcomes (2)

  • Feasibility of paired tissue sample acquisition

    7-10 Days

  • Acceptance of study

    28 Days

Other Outcomes (1)

  • Failure rate of planned laboratory assays

    7-10 days

Study Arms (1)

Intratumoral Ipilimumab

EXPERIMENTAL

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

Drug: Intratumoral Ipilimumab

Interventions

Intratumoral IpilimumabDRUG

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.

Also known as: Yervoy, BMS734016, MDX-010
Intratumoral Ipilimumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with SCCHN who are planned for surgical resection and in the opinion of the surgeon are able to safely undergo tissue biopsy plus intratumoral (IT) injection in advance, with special consideration given to risk of occlusion or compression of airway or major vessels in the neck, secondary to tumor swelling, or erosion into a major vessel in the case of necrosis.
  • Age 18 years or above with ability to give informed consent, comply with the protocol and sign a study-specific consent document. Patients with history of psychiatric illness must be judged by the investigator as able to understand the investigational nature and risks associated with the therapy.
  • Any Eastern Cooperative Oncology Group (ECOG) performance status deemed suitable by investigator for requirements of study, to potentially include incisional office biopsy of lesion, or image guided multiple 18g core needle biopsies (5 minimum) by interventional radiology, followed immediately by direct injection of lesion with drug.
  • Patients must have blood test results within protocol-specified parameters
  • Men must agree to not attempt to become a new father for a total of 165 days post-treatment completion
  • Women must agree not to become pregnant for a total of 105 days post treatment completion

You may not qualify if:

  • Any clinical factors such as bleeding, active infection, colitis history or psychiatric factors that in the judgment of the investigator would preclude safe participation and compliance with study procedures.
  • Need for chronic maintenance oral steroids ≥ 20mg prednisone daily equivalent; inhaled steroids are acceptable.
  • Infectious diseases including human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and hepatitis C virus (HCV).
  • Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

Location

Related Links

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Rom S Leidner, MD

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

  • R. Bryan Bell, MD, DDS

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 24, 2016

Study Start

November 18, 2016

Primary Completion

September 21, 2019

Study Completion (Estimated)

December 1, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)