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Anti-OX40 Antibody in Head and Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT02274155
Recruitment Status : Active, not recruiting
First Posted : October 24, 2014
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Providence Health & Services

Brief Summary:
The purpose of this study is to test the safety of the anti-OX40 antibody, MEDI6469, given prior to surgery in patients with advanced head and neck squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Anti-OX40 antibody administration Procedure: Surgical Resection Phase 1

Detailed Description:
This phase Ib clinical trial uses MEDI6469 at various dose intervals prior to definitive surgical resection of patients with stage III and IV Oral Head and Neck Squamous Cell Carcinoma (OHNSCC) with the primary objective of determining the safety and feasibility of preoperative MEDI6469 administration. In addition, tumor tissue and peripheral blood will be obtained for exploratory immunologic end points including measurements of tumor infiltrating immune cell populations based on flow cytometry and immunohistochemistry as well as circulating immunological parameters that may correlate with changes induced by MEDI6469 administration.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study of a Monoclonal Antibody to OX40 (MEDI6469) Administered Prior to Definitive Surgical Resection Patients With Locoregionally Advanced, Oral Head and Neck Squamous Cell Carcinoma
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Anti-OX40 antibody administration 3 weeks prior to surgical resection
Drug: Anti-OX40 antibody administration
Anti-OX40 antibody administration at 0.4 mg/kg IV x 3 doses given on Days 1, 3 or 4, and 5 or 6 of study
Other Name: MEDI6469

Procedure: Surgical Resection
Surgical Resection of Tumor

Experimental: Group 2
Anti-OX40 antibody administration 2 weeks prior to surgical resection
Drug: Anti-OX40 antibody administration
Anti-OX40 antibody administration at 0.4 mg/kg IV x 3 doses given on Days 1, 3 or 4, and 5 or 6 of study
Other Name: MEDI6469

Procedure: Surgical Resection
Surgical Resection of Tumor

Experimental: Group 3
Anti-OX40 antibody administration 1 week prior to surgical resection
Drug: Anti-OX40 antibody administration
Anti-OX40 antibody administration at 0.4 mg/kg IV x 3 doses given on Days 1, 3 or 4, and 5 or 6 of study
Other Name: MEDI6469

Procedure: Surgical Resection
Surgical Resection of Tumor




Primary Outcome Measures :
  1. Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration [ Time Frame: 55 Days ]
    Patients will be seen in clinic 7 times over 55 days to identify any possible side effects or complications thought to be related to the study drug to help identify the optimal treatment schedule.


Secondary Outcome Measures :
  1. Immunologic phenotypes of lymphocyte subsets [ Time Frame: 55 days ]
    An uninvolved tumor-draining lymph node, primary tumor, and metastatic lymph nodes will be obtained during surgery, and peripheral blood will be collected 7 times over 55 days to identify the composition and immunologic phenotypes of lymphocyte subsets. This will also be compared to historical controls.


Other Outcome Measures:
  1. Clinical Outcome of Imaging [ Time Frame: 5 years ]
    Clinical surveillance for recurrence as per PET +/- CT within 6 months of completion of treatment exam. Clinical outcomes will be compared to historical controls.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with treatment naive, resectable, stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for definitive surgical resection followed by standard risk adapted adjuvant therapy.
  • Histologic or cytologic diagnosis of a primary OHNSCC with no radiological evidence of metastatic disease is acceptable. Patients with bone or cartilage invasion and any T or N stage are acceptable.
  • Patients with oral cavity primaries will be managed using conventional transoral or transcervical techniques; oropharynx or hypopharynx tumor will be managed with transoral robotic surgery; and larynx tumors (T3/T4 with thyroid cartilage invasion) will be managed by either total laryngectomy or larynx preservation surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Laboratory values (performed within 28 days prior to enrollment) within protocol defined range
  • Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.
  • No active gastrointestinal bleeding.
  • Anticipated lifespan greater than 12 weeks.

Exclusion Criteria:

  • Locoregionally unresectable or Metastatic disease (stage IVB)
  • Active infection.
  • Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire.
  • Previous treatment with mouse monoclonal antibodies
  • Need for chronic maintenance oral steroids > 5mg prednisone daily equivalent.
  • Any medical or psychiatric condition that in the opinion of the investigator would preclude compliance with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274155


Locations
United States, Oregon
Portland Providence Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
MedImmune LLC
Investigators
Principal Investigator: Richard B. Bell, MD Providence Cancer Center

Additional Information:
Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02274155     History of Changes
Other Study ID Numbers: 14-042A
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Providence Health & Services:
Head and Neck Cancer
anti-OX40 antibody
MEDI6469
Immunotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs