Head and Neck Cancer Clinical Trial
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
Verified date | February 2024 |
Source | Providence Health & Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 21, 2023 |
Est. primary completion date | September 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Portland Providence Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Providence Health & Services | MedImmune LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Outcome of Imaging | Clinical surveillance for recurrence as per PET +/- CT within 6 months of completion of treatment exam. Clinical outcomes will be compared to historical controls. | 5 years | |
Primary | Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration | 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. | 55 Days | |
Secondary | Immunologic phenotypes of lymphocyte subsets | 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. | 55 days |
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