Status:
COMPLETED
Anti-OX40 Antibody in Head and Neck Cancer Patients
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
MedImmune LLC
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02274155
Start Date
November 12 2014
End Date
December 21 2023
Last Update
February 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Portland Providence Medical Center
Portland, Oregon, United States, 97213