NCT03336606

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	MEDI0562	Surgical resection of tumor

Timeline

• Start date: 2018-07-25
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2017-11-08
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study