Study on Carboplatin, Nab-Paclitaxel, and Durvalumab Before Surgery for Head and Neck Cancer

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT03174275

This clinical trial is testing a combination of chemotherapy and immunotherapy drugs given before surgery to see if it can help control head and neck cancer better than standard treatments, potentially avoiding the need for radiation therapy.

Patient Parameters

Parameter	Options

Program Overview

This study is for patients with a type of cancer called squamous cell carcinoma of the head and neck (SCCHN) that has spread locally but can still be treated with surgery. The goal is to see if a combination of chemotherapy drugs (carboplatin and nab-paclitaxel) and an immunotherapy drug (durvalumab) given before surgery can shrink the cancer and improve outcomes. Researchers hope this approach will reduce the need for radiation therapy, which can have severe side effects. The study will also look at how well patients do after treatment, including their quality of life, speech, and swallowing abilities.

Description

The study is divided into three parts:

Part 1: Patients will receive chemotherapy with carboplatin and nab-paclitaxel weekly for six weeks, along with durvalumab every two weeks for five doses.

Part 2: After chemotherapy, patients will have imaging tests followed by surgery to remove the cancer.

Part 3: After surgery, patients will be categorized into risk groups based on their cancer's characteristics. Low-risk patients will receive durvalumab every two weeks for three doses. Medium and high-risk patients will receive additional chemoradiation therapy followed by durvalumab.

Patients will be monitored every three months for 18 months after treatment to check for cancer progression. Follow-up visits will include physical exams and imaging tests. After 18 months, patients will continue to be monitored as part of their standard care.

Eligibility Criteria

Inclusion Criteria

Have not received prior treatment for head and neck cancer.
Have a type of head and neck cancer that can be surgically removed and is at stage III or IV.
Be in good overall health with an ECOG performance status of 0 or 1.
Have measurable cancer as defined by standard criteria.
Be 18 years or older.
Have adequate blood cell counts and organ function.
Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
Agree to provide tissue samples for research purposes.
Sign an informed consent form and agree to follow study procedures.

Exclusion Criteria

Have metastatic disease (cancer that has spread to other parts of the body).
Have a history of tuberculosis or lung inflammation.
Have low-risk HPV-positive oropharyngeal cancer.
Have active liver or bile duct disease.
Have had major surgery within 28 days before starting the study.
Have serious infections or medical conditions that could interfere with the study.
Have autoimmune or inflammatory disorders that require treatment.
Have a history of severe allergic reactions to study drugs.
Be pregnant or breastfeeding.
Have used immunosuppressive medications recently.
Have a history of organ transplant or primary immunodeficiency.
Have received a live vaccine recently.

Locations

FACILITY	ZIP	CITY	STATE
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill	27599	Chapel Hill	North Carolina
Vanderbilt University Medical Center	37232	Nashville	Tennessee

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