Back to results

Anti-OX40 Antibody in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Anti-OX40 antibody administration

Surgical Resection

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, anti-OX40 antibody, MEDI6469, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Portland Providence Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Anti-OX40 antibody administration 3 weeks prior to surgical resection

Anti-OX40 antibody administration 2 weeks prior to surgical resection

Anti-OX40 antibody administration 1 week prior to surgical resection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Immunologic phenotypes of lymphocyte subsets

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.

Full Information

NCT ID

NCT02274155

First Posted

October 14, 2014

Last Updated

June 2, 2023

Sponsor

Providence Health & Services

Collaborators

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT02274155

Brief Title

Anti-OX40 Antibody in Head and Neck Cancer Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 12, 2014 (Actual)

Primary Completion Date

September 17, 2017 (Actual)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Providence Health & Services

Collaborators

MedImmune LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Anti-OX40 antibody administration 3 weeks prior to surgical resection

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Anti-OX40 antibody administration 2 weeks prior to surgical resection

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Anti-OX40 antibody administration 1 week prior to surgical resection

Intervention Type

Drug

Intervention Name(s)

Anti-OX40 antibody administration

Other Intervention Name(s)

MEDI6469

Intervention Description

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

Procedure

Intervention Name(s)

Surgical Resection

Intervention Description

Surgical Resection of Tumor

Primary Outcome Measure Information:

Title

Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration

Description

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.

Time Frame

55 Days

Secondary Outcome Measure Information:

Title

Immunologic phenotypes of lymphocyte subsets

Description

Time Frame

55 days

Other Pre-specified Outcome Measures:

Title

Clinical Outcome of Imaging

Description

Clinical surveillance for recurrence as per PET +/- CT within 6 months of completion of treatment exam. Clinical outcomes will be compared to historical controls.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard B. Bell, MD

Organizational Affiliation

Providence Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Portland Providence Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33594075

Citation

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.

Results Reference

derived

Links:

URL

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

Description

Providence Cancer Center

Learn more about this trial

Anti-OX40 Antibody in Head and Neck Cancer Patients

We'll reach out to this number within 24 hrs