Anti-OX40 Antibody in Head and Neck Cancer Patients

NCT ID: NCT02274155

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-12
• Study Completion Date: 2023-12-21

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Anti-OX40 antibody administration 3 weeks prior to surgical resection

Group Type: EXPERIMENTAL

Anti-OX40 antibody administration

Intervention Type: DRUG

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

Surgical Resection

Intervention Type: PROCEDURE

Surgical Resection of Tumor

Group 2

Anti-OX40 antibody administration 2 weeks prior to surgical resection

Group Type: EXPERIMENTAL

Anti-OX40 antibody administration

Intervention Type: DRUG

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

Surgical Resection

Intervention Type: PROCEDURE

Surgical Resection of Tumor

Group 3

Anti-OX40 antibody administration 1 week prior to surgical resection

Group Type: EXPERIMENTAL

Anti-OX40 antibody administration

Intervention Type: DRUG

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

Surgical Resection

Intervention Type: PROCEDURE

Surgical Resection of Tumor

Interventions

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

Intervention Type: DRUG

Surgical Resection

Surgical Resection of Tumor

Intervention Type: PROCEDURE

Other Intervention Names

MEDI6469

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard B. Bell, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Cancer Center

Locations

Portland Providence Medical Center

Portland, Oregon, United States

Countries

United States

References

Duhen R, Ballesteros-Merino C, Frye AK, Tran E, Rajamanickam V, Chang SC, Koguchi Y, Bifulco CB, Bernard B, Leidner RS, Curti BD, Fox BA, Urba WJ, Bell RB, Weinberg AD. Neoadjuvant anti-OX40 (MEDI6469) therapy in patients with head and neck squamous cell carcinoma activates and expands antigen-specific tumor-infiltrating T cells. Nat Commun. 2021 Feb 16;12(1):1047. doi: 10.1038/s41467-021-21383-1.

Reference Type: DERIVED

PMID: 33594075 (View on PubMed)

Related Links

http://oregon.providence.org/our-services/p/providence-cancer-center/

Providence Cancer Center

Other Identifiers

14-042A

Identifier Type: -

Identifier Source: org_study_id