Anti-OX40 Antibody in Head and Neck Cancer Patients

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Collaborator: MedImmune LLC
• Treatments: Antibodies; Immunoglobulins

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.