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

NCT02827838 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-03-17

Study results available
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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.

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

Interventions

BIOLOGICAL

Durvalumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Mercedes Porosnicu · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-04-22
Completion
2022-04-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02827838 on ClinicalTrials.gov