Durvalumab + Radiotherapy for Oral Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySiddharth Sheth, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Siddharth Sheth, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

Adults over 18 with intermediate-risk head and neck cancer who've had surgery but no prior treatment for the tumor. They must be in good health, have a performance status of 0 or 1, and women must not be pregnant and agree to contraception. People can't join if they're on other cancer treatments, have an allergy to durvalumab, are immunosuppressed, have certain infections like HIV or hepatitis B/C, or autoimmune diseases.

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

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

I am 18 years old or older.

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Exclusion Criteria

Treatment with any investigational drug within 28 days or 5 half-lives of Day 1 of treatment on this study, whichever is shortest

My cancer has spread to other parts of my body.

I am currently undergoing treatment with chemotherapy, investigational drugs, or hormone therapy for cancer.

See 17 more

Treatment Details

Interventions

Durvalumab (Checkpoint Inhibitor)
Intensity Modulated Radiotherapy Treatments (Radiation)

Trial OverviewThe trial is testing whether combining durvalumab (an immune system-boosting drug) with intensity-modulated radiotherapy improves cure rates while causing fewer side effects than traditional treatments for head and neck cancers. Durvalumab isn't yet approved for this type of cancer but has been used in bladder cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Open-label, single-armExperimental Treatment2 Interventions

Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments