First Line Chemotherapy (Carboplatin and Paclitaxel) and Immunotherapy (Pembrolizumab) for the Treatment of Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Status: active

This phase II trial studies the effects of first line chemotherapy (carboplatin and paclitaxel) and immunotherapy (pembrolizumab) in treating patients with head and neck squamous cell carcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy (carboplatin and paclitaxel) and immunotherapy (pembrolizumab) may work better in treating patients with head and neck squamous cell cancer unable to take fluorouracil.

Inclusion Criteria

Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or neck node with occult primary but suspected to be non-cutaneous head/neck, that is incurable by local therapies (i.e. radiation or surgery) and either locoregionally advanced or with at least one distant metastasis
Histologic or cytologic confirmation of malignancy by pathology report
Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other)
18 years old or greater
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Life expectancy of greater than 3 months
Absolute neutrophil count >= 1,000/mcL
Platelets >= 75,000/mcL
Total bilirubin =< 2 mg/dL
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria

No prior systemic cancer-directed therapy administered in the recurrent or metastatic setting. Prior treatments are allowed if they were administered with curative intent prior to incurable progression of disease. Prior treatments for other cancers are also allowed
Untreated, symptomatic central nervous system (CNS) metastases
Active autoimmune disease requiring systemic immunosuppression
History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone > 20 mg/day for > 1 week)
History of grade >= 3 hypersensitivity reaction to carboplatin or paclitaxel
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because paclitaxel and carboplatin are class D agents with significant potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued during the study

PRIMARY OBJECTIVE:

I. To determine if 6 cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic head and neck squamous cell carcinoma (HNSCC) patients increases the radiographic response rate as compared to the historical rate for pembrolizumab alone.

SECONDARY OBJECTIVES:

I. To determine if 6 cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic HNSCC patients increases median overall survival (OS) as compared to the historical rate reported for pembrolizumab alone.

II. To determine if 6 cycles of pembrolizumab with weekly carboplatin and paclitaxel followed by pembrolizumab alone for the 1st line treatment of metastatic HNSCC patients increases the median progression-free survival (PFS) as compared to the historical rate reported for pembrolizumab alone.

III. To determine the toxicity profile of 6 cycles of pembrolizumab with weekly carboplatin/paclitaxel/pembrolizumab alone for the 1st line treatment of metastatic HNSCC patients, measured as the proportion of patients with discontinuation of any study drug due to any adverse event of any cause, as compared to the historical proportion reported for platinum/fluorouracil (5FU)/pembrolizumab (33%).

EXPLORATORY OBJECTIVES:

I. To measure how overall quality of life as measured by global patient reported outcomes is impacted by 6 cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic HNSCC patients.

II. To measure how respiratory patient reported outcomes (PROs) are impacted by 6 cycles of pembrolizumab with weekly carboplatin/paclitaxel for the 1st line treatment of metastatic HNSCC patients.

III. To compare the level of immune activation in blood and saliva in patients who start treatment with immunotherapy and chemotherapy concurrently vs sequentially, with immunochemotherapy first or chemotherapy first.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and carboplatin IV and paclitaxel IV on days 1, 8, and 15. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection as well as a computed tomography (CT) scan, and may also undergo a magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up at 21 days and then every 28 days for up to 2 years.

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First Line Chemotherapy (Carboplatin and Paclitaxel) and Immunotherapy (Pembrolizumab) for the Treatment of Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

United States

North Carolina

Winston-Salem

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First Line Chemotherapy (Carboplatin and Paclitaxel) and Immunotherapy (Pembrolizumab) for the Treatment of Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

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