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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT02827838
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Human Papillomavirus Infection
  • Stage I Oral Cavity Squamous Cell Carcinoma
  • Stage I Oropharyngeal Squamous Cell Carcinoma
  • Stage II Oral Cavity Squamous Cell Carcinoma
  • Stage II Oropharyngeal Squamous Cell Carcinoma
  • Stage III Oral Cavity Squamous Cell Carcinoma
  • Stage III Oropharyngeal Squamous Cell Carcinoma
  • Stage IVA Oral Cavity Squamous Cell Carcinoma
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma
  • Stage IVB Oral Cavity Squamous Cell Carcinoma
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma
  • Stage IVC Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgery

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Feb 2025
Primary completion
Apr 22, 2022
Completion
Apr 22, 2022

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (durvalumab, surgery)
    Patients receive durvalumab 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.

Primary Outcome Measure

Immune Effector Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry [ Time Frame: Up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Cancer Center of Wake Forest UniversityWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By research site
Comprehensive Cancer Center of Wake Forest University· Winston-Salem, NC

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