Trials / Terminated

TerminatedNCT02827838

Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer

Pilot Study to Evaluate the Anti-Tumor Effect of Durvalumab (Medi4736) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN), Human Papilloma Virus (HPV) Positive Versus Negative, When Treated Before Surgery

Status: Terminated
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 17 (actual)

Sponsor: Wake Forest University Health Sciences · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To investigate the effect of durvalumab on local and systemic immune activation by HPV status in patients with oral cavity and oropharynx head and neck squamous cell carcinoma (HNSCC). II. To examine the effects of durvalumab on systemic immune response to HPV and tumor associated antigens. III. To examine the effects of durvalumab on immune regulatory mechanisms. IV. To explore the association between levels of immune-regulatory micro-ribonucleic acid (miR) in plasma and saliva and immune response. SECONDARY OBJECTIVES: I. Investigate the effect of the treatment with durvalumab on the computed tomography (CT) scan and positron emission tomography (PET) scan response. II. Evaluate the safety of a short induction treatment with durvalumab. OUTLINE: Patients receive durvalumab intravenously (IV) over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days. After completion of study treatment, patients are followed up for 90 days.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

Start date: 2017-01-01
Primary completion: 2022-04-22
Completion: 2022-04-22
First posted: 2016-07-11
Last updated: 2025-03-17
Results posted: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02827838. Inclusion in this directory is not an endorsement.