Clinical trial NCT04858269: First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
Official title: Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head Neck Cancer
Metastatic Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma
Hypopharynx Squamous Cell Carcinoma
Larynx Squamous Cell Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-04-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil

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

Secondary Objective(s):

* To determine if six (6) cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients increases median overall survival (OS) as compared to the historical rate reported for pembrolizumab alone.
* To determine if six (6) cycles of pembrolizumab with weekly carboplatin and paclitaxel followed by pembrolizumab alone for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients increases the median progression-free survival (PFS) as compared to the historical rate reported for pembrolizumab alone.
* To determine the toxicity profile of six (6) cycles of pembrolizumab with weekly carboplatin/paclitaxel/pembrolizumab alone for the 1st line treatment of metastatic head/neck squamous cell carcinoma 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/5FU/ pembrolizumab (33%).

Eligibility criteria: 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.
* ECOG performance status of 0-2.
* Life expectancy of greater than 3 months.
* Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL
* Ability to understand and the willingness to sign an 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 greater than or equal to 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 outcomes:
measure: Response Rate
timeFrame: At 18 weeks on study
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 2 years
measure: Progression-Free Survival
timeFrame: Up to 2 years
measure: Number of Participants with Discontinuation of Study Drug due to Adverse Effects of Any Cause
timeFrame: Up to 18 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Health Sciences
name: Thomas Lycan, DO
role: PRINCIPAL_INVESTIGATOR
References: