Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma

NCT03336606 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 2017000254
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  28 days

Secondary Outcomes (4)

• Cancer-related clinical outcomes (progression free survival)

  5 years

• Cancer-related clinical outcomes (overall survival)

  5 years

• Incidence of Treatment-Emergent Adverse Events in patients with HNSCC or melanoma treated with MEDI0562 (Safety & Tolerability)

  5 years

• Surgical complications after MEDI0562

  28 days

Study Arms (2)

Cohort I

ACTIVE COMPARATOR

MEDI0562 administration (90mg on day 1) followed by surgical resection (day 15)

Drug: MEDI0562

Cohort II

ACTIVE COMPARATOR

MEDI0562 administration (30mg on days 1, 3, 5) followed by surgical resection (day 15)

Drug: MEDI0562

Interventions

MEDI0562 DRUG

Surgical resection of tumor

Also known as: Surgical Resection

Cohort I; Cohort II

Eligibility Criteria

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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:
• 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:

Sponsors & Collaborators

• Providence Health & Services: lead
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator
• MedImmune LLC: collaborator

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Related Links

• Providence Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Melanoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brenden Curti, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 8, 2017
• Study Start: July 25, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)