Head and Neck CancerPhase 1NCT03336606
Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma
A Phase 1 study testing MEDI0562 in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Providence Health & Services at 1 site in United States.
Trial summary
This clinical trial will evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Melanoma
- What is being tested?
- MEDI0562
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2018to 14 May 2026
- 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 advanced head and neck squamous cell carcinoma (HNSCC) or stage IIIb/IIIC melanoma who are candidates for R0 surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Age 18 years or above
- Laboratory values:
- WBC ≥2000/uL
- Hgb >8g/dl (patients may be transfused to reach this level)
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- Platelets >75,000 cells/mm3
- Serum creatinine 3 X upper limit of laboratory normal
- Negative bHCG (urine/serum) [women of childbearing potential only]
- AST (SGOT) and ALT (SGPT) <2.5 X upper limit of laboratory normal
- Alkaline phosphatase <2.5 X upper limit of laboratory normal
- Total bilirubin <1.5 X upper limit of laboratory normal, unless due to Gilbert's disease
- INR <1.5, PT <16 seconds, PTT < 38 seconds
- Ability to give informed consent and comply with the protocol
- Anticipated lifespan >12 weeks
- Women of childbearing potential: negative serum/urine pregnancy test <96 hours prior to start of study
- Males and women of childbearing potential: must agree to take appropriate precautions to avoid pregnancy during treatment and through 90 days after last dose of IP
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/MedImmune staff and/or staff at the study site)
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment
- Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment -- concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy). -Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable. -Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. -History of allogenic organ transplantation.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent -History of another primary malignancy except for:
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- Malignancy treated with curative intent and with no known active disease ≥1.5 years before the first dose of investigational product and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease -History of leptomeningeal carcinomatosis -Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: patients whose brain metastases have been treated may participate provided they show radiographic stability (imaging at least four weeks apart showing no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either without the use of steroids or are stable on a steroid dose of ≤10mg/day of prednisone or its equivalent and anti-seizure medications for at least 14 days prior to the start of treatment. Patients on a stable dose of seizure medicines for epilepsy unrelated to cancer are eligible for the trial.
- Active or recent history of diverticulitis. Note: Patients with known diverticulosis are permitted to enroll.
- History of active primary immunodeficiency. -Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice); hepatitis B (known positive HBV surface antigen (HBsAg) result); hepatitis C; or human immunodeficiency virus (positive HIV 1/2 antibodies). Note: patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients with treated HIV, as evidenced by stable CD4 > 200 for at least 6 months, are eligible. -Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug. The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease]; diverticulitis [with the exception of diverticulosis]; systemic lupus erythematosus; Sarcoidosis syndrome; or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 5 years may be included but only after consultation with the study physician • Patients with celiac disease controlled by diet alone -Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP -Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients. -Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia, and the laboratory values defined in the inclusion criteria. -Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. -Patients with irreversible toxicity not reasonably expected to be exacerbated by study treatment may be included only after consultation with the Study Physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: Phase Ib Study of a Monoclonal Antibody to OX40 (MEDI0562) Administered Prior to Surgical Resection in Patients With Head and Neck Squamous Cell Carcinoma or Melanoma
This clinical trial will evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma.
Read the detailed description
This clinical trial is the first to evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma.
Patients will be randomly assigned to one of two MEDI0562 administration schedules; initially 5 patients will enroll to each cohort. All patients will have a tumor biopsy before administration of MEDI0562 and surgery will be performed on approximately day 15 (+/- 2 days).
There will be a comparison of a surgical specimen to the original biopsy focusing on the composition and immunologic phenotypes of lymphocyte subsets. Although the primary endpoint of this study is immunological, valuable exploratory data on clinical outcomes will also be obtained.
Both the HNSCC and the melanoma patients to be enrolled on this trial are anticipated to have a 50 - 90% probability of recurrence within 5 years after surgery, even with current state-of-the-art post-surgical adjuvant radiation, chemotherapy, or immunotherapy. A recurrence of 25% or less within the 12 months after surgery will be deemed of clinical interest and would inform the design of a larger follow-up study.
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Melanoma, Cell Cancer, Squamous, Carcinoma, Squamous Cell
- Being tested
- MEDI0562
- Keywords
- immunotherapy, OX40, antibodies, HNSCC, melanoma, phase 1, squamous cell
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Melanoma, Neoplasms, Squamous Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0562Drug
Also called Surgical Resection
Surgical resection of tumor
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Active comparator | MEDI0562 administration (90mg on day 1) followed by surgical resection (day 15) Receives: Drug: MEDI0562 |
| Cohort II | Active comparator | MEDI0562 administration (30mg on days 1, 3, 5) followed by surgical resection (day 15) Receives: Drug: MEDI0562 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of immune response
The primary objective of this phase Ib clinical trial is to ascertain if there is a difference in immune activation comparing a single dose of MEDI0562 with the equivalent dose divided into a Monday, Wednesday Friday schedule in patients with advanced HNSCC or melanoma. Immune activation will be assessed as a cumulative suppressive index (CSI).
Measured: 28 days
Secondary outcomes (4)
Cancer-related clinical outcomes (progression free survival)
Cancer-related clinical outcomes in patients receiving MEDI0562 will be compared with historical controls for progression free survival.
Measured: 5 years
Cancer-related clinical outcomes (overall survival)
Cancer-related clinical outcomes in patients receiving MEDI0562 will be compared with historical controls for overall survival.
Measured: 5 years
Incidence of Treatment-Emergent Adverse Events in patients with HNSCC or melanoma treated with MEDI0562 (Safety & Tolerability)
The safety of MEDI0562 administration in patients with locally advanced HNSCC and melanoma will be monitored using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 5 years
Surgical complications after MEDI0562
Surgical complications after MEDI0562 administration will be monitored using the Clavien-Dindo grading system.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start25 Jul 2018
- Primary completion12 Jun 2025
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be stratified by tumor type and randomly assigned to a MEDI0562 administration schedule; initially 5 patients will enroll to each of two cohorts.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute, MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Brenden Curti, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336606
- Sponsor's protocol ID
- 2017000254
- Status last verified
- May 2026
- First submitted
- 24 Oct 2017
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of a Monoclonal Antibody to OX40 (MEDI0562) Administered Prior to Surgical Resection in Patients With Head and Neck Squamous Cell Carcinoma or Melanoma
- ClinicalTrials.gov ID
- NCT03336606
- Acronym / sponsor ID
- 2017000254
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Melanoma, Cell Cancer, Squamous, Carcinoma, Squamous Cell
- Keywords
- immunotherapy, OX40, antibodies, HNSCC, melanoma, phase 1, squamous cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute, MedImmune LLC
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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.
This clinical trial will evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma.
Detailed description
This clinical trial is the first to evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma.
Patients will be randomly assigned to one of two MEDI0562 administration schedules; initially 5 patients will enroll to each cohort. All patients will have a tumor biopsy before administration of MEDI0562 and surgery will be performed on approximately day 15 (+/- 2 days).
There will be a comparison of a surgical specimen to the original biopsy focusing on the composition and immunologic phenotypes of lymphocyte subsets. Although the primary endpoint of this study is immunological, valuable exploratory data on clinical outcomes will also be obtained.
Both the HNSCC and the melanoma patients to be enrolled on this trial are anticipated to have a 50 - 90% probability of recurrence within 5 years after surgery, even with current state-of-the-art post-surgical adjuvant radiation, chemotherapy, or immunotherapy. A recurrence of 25% or less within the 12 months after surgery will be deemed of clinical interest and would inform the design of a larger follow-up study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be stratified by tumor type and randomly assigned to a MEDI0562 administration schedule; initially 5 patients will enroll to each of two cohorts.
| Arm | Type | Receives |
|---|---|---|
| Cohort I | Active comparator | Drug: MEDI0562MEDI0562 administration (90mg on day 1) followed by surgical resection (day 15) |
| Cohort II | Active comparator | Drug: MEDI0562MEDI0562 administration (30mg on days 1, 3, 5) followed by surgical resection (day 15) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with advanced head and neck squamous cell carcinoma (HNSCC) or stage IIIb/IIIC melanoma who are candidates for R0 surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Age 18 years or above
- Laboratory values:
- INR <1.5, PT <16 seconds, PTT < 38 seconds
Key exclusion criteria (14 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/MedImmune staff and/or staff at the study site)
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment
- Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment -- concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy). -Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable. -Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. -History of allogenic organ transplantation.
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 |
|---|---|---|
| MEDI0562Also: Surgical ResectionSurgical resection of tumor | Drug | Cohort I, Cohort II |
Primary outcome
Activation of immune response
Time frame: 28 days
The primary objective of this phase Ib clinical trial is to ascertain if there is a difference in immune activation comparing a single dose of MEDI0562 with the equivalent dose divided into a Monday, Wednesday Friday schedule in patients with advanced HNSCC or melanoma. Immune activation will be assessed as a cumulative suppressive index (CSI).
4 secondary outcomes
Cancer-related clinical outcomes (progression free survival)
Time frame: 5 years
Cancer-related clinical outcomes (overall survival)
Time frame: 5 years
Incidence of Treatment-Emergent Adverse Events in patients with HNSCC or melanoma treated with MEDI0562 (Safety & Tolerability)
Time frame: 5 years
Surgical complications after MEDI0562
Time frame: 28 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 22 May 2026.
- 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.
Brenden Curti, MD principal investigator
Providence Health & Services
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 MEDI0562 in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, 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 17 inclusion and 14 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 22 May 2026. 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?
Activation of immune response (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.