Head and Neck Cancer
Conditions
Keywords
Head and Neck Cancer, anti-OX40 antibody, MEDI6469, Immunotherapy
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.
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.
Interventions
DRUGAnti-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
PROCEDURESurgical Resection
Surgical Resection of Tumor
Sponsors
MedImmune LLC
Providence Health & Services
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration | 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
| Measure | Time frame | Description |
|---|---|---|
| Immunologic phenotypes of lymphocyte subsets | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome of Imaging | 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. |
Countries
United States
Outcome results
None listed