Active — Not RecruitingPhase 2

Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

United States18 participantsStarted 2019-10-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment. * Age ≥ 18 years of age on day of signing informed consent * ECOG Performance Status of 0 or 1 (See Appendix 12.4: ECOG Performance Status) * Histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, hypopharynx, larynx * Must have undergone gross total resection of the primary tumor with curative intent within the past 8 weeks with surgical pathology demonstrating ≥ 1 of the following criteria for "intermediate" risk of recurrence: * perineural invasion * lymphovascular invasion * single lymph node \> 3 cm or at least 2 nodes without evidence of extracapsular extension * close margins defined as \< 5 mm but not frankly positive (in the case of ambiguous, controversial, or superseded margins, final clinical assessment regarding margin status will prevail) * pathologically confirmed T3 or T4 primary tumor * No prior therapy to primary tumor prior to surgical resection (no induction therapy or recurrent disease). * Demonstrated adequate organ function as defined in the protocol * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to treatment. NOTE: Females are consid…

What they're measuring

Disease-free Survival Rate

Timeframe: 3 years

Trial details

NCT IDNCT03529422

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

Results submitted2025-06-20