Trial record 5 of 17 for:    Ox40

Anti-OX40 Antibody in Head and Neck Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Providence Health & Services
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT02274155
First received: October 14, 2014
Last updated: April 27, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: Anti-OX40 antibody administration
Procedure: Surgical Resection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration [ Time Frame: 55 Days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Immunologic phenotypes of lymphocyte subsets [ Time Frame: 55 days ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Clinical Outcome of Imaging [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Clinical surveillance for recurrence as per PET +/- CT within 6 months of completion of treatment exam. Clinical outcomes will be compared to historical controls.


Estimated Enrollment: 55
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Anti-OX40 antibody administration 4 weeks prior to surgical resection
Drug: Anti-OX40 antibody administration
Anti-OX40 antibody administration at 0.4 mg/kg IV x 2 doses given on day 1 & day 3, 4, or 5 of study
Other Name: MEDI6469
Procedure: Surgical Resection
Surgical Resection of Tumor
Experimental: Group 2
Anti-OX40 antibody administration 3 weeks prior to surgical resection
Drug: Anti-OX40 antibody administration
Anti-OX40 antibody administration at 0.4 mg/kg IV x 2 doses given on day 1 & day 3, 4, or 5 of study
Other Name: MEDI6469
Procedure: Surgical Resection
Surgical Resection of Tumor
Experimental: Group 3
Anti-OX40 antibody administration 2 weeks prior to surgical resection
Drug: Anti-OX40 antibody administration
Anti-OX40 antibody administration at 0.4 mg/kg IV x 2 doses given on day 1 & day 3, 4, or 5 of study
Other Name: MEDI6469
Procedure: Surgical Resection
Surgical Resection of Tumor
Experimental: Group 4
Anti-OX40 antibody administration 1 week prior to surgical resection
Drug: Anti-OX40 antibody administration
Anti-OX40 antibody administration at 0.4 mg/kg IV x 2 doses given on day 1 & day 3, 4, or 5 of study
Other Name: MEDI6469
Procedure: Surgical Resection
Surgical Resection of Tumor

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02274155

Contacts
Contact: Brenda Fisher, RN (503) 215-2613 Brenda.Fisher@Providence.org

Locations
United States, Oregon
Portland Providence Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brenda Fisher, RN    503-215-2613    Brenda.Fisher@providence.org   
Sub-Investigator: Brendan Curti, MD         
Sub-Investigator: Todd Crocenzi, MD         
Sub-Investigator: Rachel Sanborn, MD         
Sub-Investigator: Walter J. Urba, MD, PhD         
Sub-Investigator: Alison Conlin, MD         
Sub-Investigator: John Godwin, MD         
Sub-Investigator: Rom Leidner, MD         
Sub-Investigator: Rui Li, MD, PhD         
Principal Investigator: Richard B. Bell, MD, DDS         
Sub-Investigator: Tuan Bui, MD, DDS         
Sub-Investigator: Eric Dierks, MD, DMD         
Sub-Investigator: Allen Cheng, MD, DMD         
Sponsors and Collaborators
Providence Health & Services
MedImmune LLC
Investigators
Principal Investigator: Richard B. Bell, MD Providence Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02274155     History of Changes
Other Study ID Numbers: 14-042A
Study First Received: October 14, 2014
Last Updated: April 27, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Providence Health & Services:
Head and Neck Cancer
anti-OX40 antibody
MEDI6469
Immunotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Antibodies
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 07, 2015