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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04858269
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Head Neck Cancer
  • Hypopharynx Squamous Cell Carcinoma
  • Larynx Squamous Cell Carcinoma
  • Metastatic Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle
  • Carboplatin — DRUG
    Carboplatin dosed for area under the curve (AUC) 1.5 IV on days 1, 8, 15 of each 3-week cycle
  • Paclitaxel — DRUG
    Paclitaxel 45 mg/m2 on days 1, 8, 15 of 3-week cycle.

Study Details

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

Key Dates

Start date
May 27, 2021
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Response Rate [ Time Frame: At 18 weeks on study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Health SciencesWinston-SalemNorth Carolina27157-

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By research site
Wake Forest Baptist Health Sciences· Winston-Salem, NC

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