Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04858269

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

Led by Wake Forest University Health Sciences · Updated on 2026-03-24

32

Participants Needed

1

Research Sites

374 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or neck node with occult primary suspected to be non-cutaneous head/neck cancer, incurable by local therapies
  • Histologic or cytologic confirmation of malignancy by pathology report
  • Not a candidate for infusional 5-fluorouracil due to mucositis, inability to use 5-day infusional pump, patient refusal, or other reasons
  • 18 years old or older
  • ECOG performance status of 0 to 2
  • Life expectancy greater than 3 months
  • Normal organ and marrow function: absolute neutrophil count ≥ 1,000/mcL, platelets ≥ 75,000/mcL, total bilirubin ≤ 2 mg/dL
  • Ability and willingness to sign an IRB-approved informed consent document (self or legally authorized representative)
Not Eligible

You will not qualify if you...

  • No prior systemic cancer-directed therapy in the recurrent or metastatic setting; prior treatments allowed if given with curative intent before incurable progression
  • Untreated, symptomatic central nervous system metastases
  • Active autoimmune disease requiring systemic immunosuppression
  • History of autoimmune pneumonitis requiring high-dose systemic steroids
  • History of grade 3 or higher hypersensitivity to carboplatin or paclitaxel
  • Uncontrolled illnesses including active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
  • Pregnant or breastfeeding women due to potential risks from study drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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