Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

Running, not enrolling · Phase 2

Conditions studied: Larynx, Lip, Oral Cancer, Digestive Organs--Diseases

In brief

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 facts

Study ID

NCT03529422

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

18

Starts

2019-10-07

Expected to finish

2026-08-31

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.
• WOCBP must be willing to abstain from heterosexual activity or to use at least 1 highly effective method of contraception from the time of informed consent until 90 days after durvalumab monotherapy treatment is discontinued (whichever is longer). See section 5.6 of the protocol for additional details on contraception requirements for WOCBP and male participants in this trial.
• Male patients with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 90 days after durvalumab monotherapy is discontinued.
• Subjects must be willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.

You may not qualify if…

• Subjects meeting any of the following exclusion criteria will not be able to participate in this study:
• Is currently participating in or has participated in a study of an investigational agent or an investigational device within 4 weeks of the first dose of treatment.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• Has evidence of metastatic disease at time of diagnosis
• Is receiving concurrent chemotherapy, investigational drug, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• Treatment with any investigational drug within 28 days or 5 half-lives of Day 1 of treatment on this study, whichever is shortest.
• Has not received any antibiotics <7 days prior to 1st dose of durvalumab. If the patient receives either IV antibiotics or >5 day treatment course (oral or IV), then the 1st durvalumab dose should not be given until 14 days of last antibiotic dose. During eligibility screening, subjects who receive any antibiotics within 30 days prior to the proposed initial infusion of durvalumab should be flagged and reviewed by the site's Principle Investigator to determine if the subject is a good candidate to receive durvalumab.
• Known allergy or hypersensitivity to durvalumab or any of the study drug excipients.
• Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
• Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
• Has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Active infection requiring systemic therapy including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
• Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
• Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Has a known contraindication to radiation therapy, including inherited syndromes associated with hypersensitivity to ionizing radiation such as Ataxia-Telangiectasia and Nijmegen Breakage Syndrome
• Has a history of uncontrolled liver disease (including but not limited to cirrhosis).
• Subjects with baseline weight ≤ 40kg (88 lbs).
• Female patients who are pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study) or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
• History of another primary malignancy except for.
• Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Medical University of South Carolina - Hollings Cancer Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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