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

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

MEDI0562

Brenden Curti, MD

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.

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.

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

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

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).

Cancer-related clinical outcomes in patients receiving MEDI0562 will be compared with historical controls for progression free survival.

Cancer-related clinical outcomes in patients receiving MEDI0562 will be compared with historical controls for overall survival.

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.

Surgical complications after MEDI0562 administration will be monitored using the Clavien-Dindo grading system.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma	NCT03336606	Head and Neck C... Head and Neck S... Melanoma Cell Cancer, Sq... Carcinoma, Squa...	MEDI0562	18 Years -	Providence Health & Services
Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma	NCT03336606	Head and Neck C... Head and Neck S... Melanoma Cell Cancer, Sq... Carcinoma, Squa...	MEDI0562	18 Years -	Providence Health & Services

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