Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

NCT03529422 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: LCCC1725
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

Head and Neck; Larynx; Lip; Oral Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival Rate

  Disease-free Survival Rate (DFS) defined as the percentage of participants who were disease-free and alive at 3 years, counting the time from day 1 of treatment to time of disease recurrence or death, was calculated based on the Kaplan-Meier method.

  3 years

Secondary Outcomes (4)

• Number of Participants With Grade 3-4 Acute Toxicities

  Up to 30 days

• Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy

  12 weeks

• Overall Survial in Patients With Intermediate-risk HNSCC Treated With Adjuvant Durvalumab With Radiotherapy PD-L1 Expression With Disease Free Survival

  5 years

• PD-L1 Expression With Disease Free Survival.

  5 years

Study Arms (1)

Open-label, single-arm

OTHER

Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments

Drug: Durvalumab; Radiation: Intensity Modulated Radiotherapy Treatments

Interventions

Durvalumab DRUG

Durvalumab 1500mg IV every 3 weeks for 6 cycles

Also known as: Imfinzi

Open-label, single-arm

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

Also known as: IMRT

Open-label, single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (3)

University Of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Medical University of South Carolina - Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center website
• North Carolina Cancer Hospital website
• National Cancer Institute website

MeSH Terms

Conditions

Laryngeal Diseases; Lymphoid Interstitial Pneumonia; Mouth Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Melahat Canter
• Organization: UNC Lineberger Comprehensive Cancer Center

Melahat_Canter@med.unc.edu

919-962-0000

Study Officials

• Siddharth Sheth, DO MPH

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: October 7, 2019
• Primary Completion: July 1, 2024
• Study Completion: May 6, 2026
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Locations

US (3)