Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03529422
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Digestive Organs--Diseases
  • Larynx
  • Lip
  • Oral Cancer

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500mg IV every 3 weeks for 6 cycles
  • Intensity Modulated Radiotherapy Treatments — RADIATION
    Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks

Study Details

The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, this investigational drug will be referred to as the "study drug", or named individually (durvalumab). The study drug in this research is referred to as investigational because the U.S. Food and Drug Administration (FDA) has not yet approved itfor the treatment of head and neck cancer. Durvalumab was FDA approved in 2017 for the treatment of certain types of bladder cancer, but has not been approved for use in Head and Neck cancer patients. Durvalumab is an experimental drug that uses the body's immune system to fight the cancer. This study drug is being used in other ongoing clinical trials for other types of cancers. The doctor feels that a patient may experience fewer side effects using this study drug with radiation rather than using cisplatin. The doctor is also investigating whether using this drug can increase the effectiveness of treatment.

Key Dates

Start date
Oct 7, 2019
Status verified
Jul 2025
Primary completion
Jul 1, 2024
Completion
May 6, 2026

Study Design

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

Arms

  • Other: Open-label, single-arm
    Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments

Primary Outcome Measure

Disease-free Survival Rate [ Time Frame: 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
University Of Alabama At BirminghamBirminghamAlabama35294-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Medical University of South Carolina - Hollings Cancer CenterCharlestonSouth Carolina29425-

Find similar trials in Birmingham, AL

By research site
University Of Alabama At Birmingham· Birmingham, ALUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCMedical University of South Carolina - Hollings Cancer Center· Charleston, SC

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