Head and Neck CancerPhase 1NCT02274155
Anti-OX40 Antibody in Head and Neck Cancer Patients
A Phase 1 study testing Anti-OX40 antibody administration and Surgical Resection in people with Head and Neck Cancer, run by Providence Health & Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Anti-OX40 antibody administration and Surgical Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2014to 21 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Portland Providence Medical Center
Portland, Oregon, 97213
About this study
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
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.
Read the 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
- Being tested
- Anti-OX40 antibody administration, Surgical Resection
- Keywords
- Head and Neck Cancer, anti-OX40 antibody, MEDI6469, Immunotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-OX40 antibody administrationDrug
Also called MEDI6469
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 ResectionProcedure or surgery
Surgical Resection of Tumor
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Anti-OX40 antibody administration 3 weeks prior to surgical resection Receives: Drug: Anti-OX40 antibody administration; Procedure: Surgical Resection |
| Group 2 | Experimental | Anti-OX40 antibody administration 2 weeks prior to surgical resection Receives: Drug: Anti-OX40 antibody administration; Procedure: Surgical Resection |
| Group 3 | Experimental | Anti-OX40 antibody administration 1 week prior to surgical resection Receives: Drug: Anti-OX40 antibody administration; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 55 Days
Secondary outcomes (1)
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.
Measured: 55 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start12 Nov 2014
- Primary completion17 Sep 2017
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Richard B. Bell, MD, Principal investigator, Providence Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274155
- Sponsor's protocol ID
- 14-042A
- Status last verified
- Feb 2024
- First submitted
- 14 Oct 2014
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33594075
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02274155
- Acronym / sponsor ID
- 14-042A
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, anti-OX40 antibody, MEDI6469, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 17 Sep 2017 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Anti-OX40 antibody administration, Procedure: Surgical ResectionAnti-OX40 antibody administration 3 weeks prior to surgical resection |
| Group 2 | Experimental | Drug: Anti-OX40 antibody administration, Procedure: Surgical ResectionAnti-OX40 antibody administration 2 weeks prior to surgical resection |
| Group 3 | Experimental | Drug: Anti-OX40 antibody administration, Procedure: Surgical ResectionAnti-OX40 antibody administration 1 week prior to surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-OX40 antibody administrationAlso: MEDI6469Anti-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 | Drug | Group 1, Group 2, Group 3 |
| Surgical ResectionSurgical Resection of Tumor | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration
Time frame: 55 Days
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.
1 secondary outcome
Immunologic phenotypes of lymphocyte subsets
Time frame: 55 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 33594075Duhen 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.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B. Bell, MD principal investigator
Providence Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-OX40 antibody administration and Surgical Resection in people with Head and Neck Cancer, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration (time frame: 55 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02274155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.