First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

NCT ID: NCT04858269

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2028-08-31

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%).

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.

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination of Chemotherapy and Immunotherapy

The intervention will be administered on an outpatient basis. The treatment regimen will consist of combination chemotherapy and immunotherapy administered as: Pembrolizumab PLUS Carboplatin PLUS Paclitaxel.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle

Carboplatin

Intervention Type: DRUG

Carboplatin dosed for area under the curve (AUC) 1.5 IV on days 1, 8, 15 of each 3-week cycle

Paclitaxel

Intervention Type: DRUG

Paclitaxel 45 mg/m2 on days 1, 8, 15 of 3-week cycle.

Interventions

Pembrolizumab

Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle

Intervention Type: DRUG

Carboplatin

Carboplatin dosed for area under the curve (AUC) 1.5 IV on days 1, 8, 15 of each 3-week cycle

Intervention Type: DRUG

Paclitaxel

Paclitaxel 45 mg/m2 on days 1, 8, 15 of 3-week cycle.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Lycan, DO

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Health Sciences

Locations

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Nurse

Role: CONTACT

saverill@wakehealth.edu

336-713-5440

Jeffrey Kettler

Role: CONTACT

jkettler@wakehealth.edu

336-713-5440

Facility Contacts

Study Nurse

Role: primary

saverill@wakehealth.edu

Other Identifiers

WFBCCC 60121

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00072117

Identifier Type: -

Identifier Source: org_study_id