Mayo Clinic
This phase II trial tests the effect of early (induction) standard chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab in preventing more extensive surgery to remove the voice box (laryngectomy), in patients with laryngeal squamous cell cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or hypopharyngeal cancer of any stage. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Response to treatment with chemoimmunotherapy may help guide further treatment, such as radiation therapy with or without cisplatin. Intensity-modulated radiation therapy (IMRT) is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Intensity-modulated proton therapy is a type of proton beam radiation therapy that uses precise proton beams to target tumors while sparing the surrounding healthy tissue. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Giving induction chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab may be an effective strategy to prevent more invasive treatments, such as a laryngectomy, while improving both survival and quality of life in patients with advanced laryngeal squamous cell carcinoma and hypopharyngeal squamous cell carcinoma.
Inclusion Criteria: * Age ≥ 18 years * Histological confirmation of squamous cell carcinoma of larynx or hypopharynx. Larynx squamous cell carcinoma is ≥ cT2N+ or cT3-4N any, or any hypopharynx cancer regardless of stage. Individuals with a new diagnosis or who were previously treated with endoscopic resections alone are eligible * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * Ability to complete questionnaire(s) by themselves or with assistance * Provide written…
Undergo blood and drain fluid sample collection
Given IV
Given chemotherapy
Given IV
Undergo CT and PET/CT
Ancillary studies
Undergo intensity-modulated proton therapy
Undergo IMRT
Undergo laryngectomy
Given IV
Given IV
Undergo PET/CT
Ancillary studies
Undergo adjuvant RT