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

NCT04858269 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-22

No results posted yet for this study

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

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

Interventions

DRUG

Pembrolizumab

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

DRUG

Carboplatin

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

DRUG

Paclitaxel

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Thomas Lycan, DO · Wake Forest Baptist Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2026-06-30
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858269 on ClinicalTrials.gov