Anti-OX40 Antibody in Head and Neck Cancer Patients

NCT02274155 | Completed Phase 1

• 1 other identifier: 14-042A
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; anti-OX40 antibody; MEDI6469; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunologic phenotypes of lymphocyte subsets

  55 days

Other Outcomes (1)

• Clinical Outcome of Imaging

  5 years

Study Arms (3)

Group 1

EXPERIMENTAL

Anti-OX40 antibody administration 3 weeks prior to surgical resection

Drug: Anti-OX40 antibody administration; Procedure: Surgical Resection

Group 2

EXPERIMENTAL

Anti-OX40 antibody administration 2 weeks prior to surgical resection

Drug: Anti-OX40 antibody administration; Procedure: Surgical Resection

Group 3

EXPERIMENTAL

Anti-OX40 antibody administration 1 week prior to surgical resection

Drug: Anti-OX40 antibody administration; Procedure: Surgical Resection

Interventions

Anti-OX40 antibody administration 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

Also known as: MEDI6469

Group 1; Group 2; Group 3

Surgical Resection PROCEDURE

Surgical Resection of Tumor

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• MedImmune LLC: collaborator

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

Location

Related Publications (1)

• 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.

  PMID: 33594075 DERIVED

Related Links

• Providence Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Richard B. Bell, MD

  Providence Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 24, 2014
• Study Start: November 12, 2014
• Primary Completion: September 17, 2017
• Study Completion: December 21, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)