Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Conditions

• Name Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
• Stage II Oropharyngeal Squamous Cell Carcinoma
• Stage III Hypopharyngeal Squamous Cell Carcinoma
• Stage III Laryngeal Squamous Cell Carcinoma
• Stage III Oral Cavity Squamous Cell Carcinoma
• Stage III Oropharyngeal Squamous Cell Carcinoma
• Stage IV Hypopharyngeal Squamous Cell Carcinoma
• Stage IV Laryngeal Squamous Cell Carcinoma
• Stage IV Oral Cavity Squamous Cell Carcinoma
• Stage IV Oropharyngeal Squamous Cell Carcinoma
• Stage IVA Hypopharyngeal Squamous Cell Carcinoma
• Stage IVA Laryngeal Squamous Cell Carcinoma
• Stage IVA Oral Cavity Squamous Cell Carcinoma
• Stage IVA Oropharyngeal Squamous Cell Carcinoma
• Stage IVB Hypopharyngeal Squamous Cell Carcinoma
• Stage IVB Laryngeal Squamous Cell Carcinoma
• Stage IVB Oral Cavity Squamous Cell Carcinoma
• Stage IVB Oropharyngeal Squamous Cell Carcinoma
• Stage IVC Hypopharyngeal Squamous Cell Carcinoma
• Stage IVC Laryngeal Squamous Cell Carcinoma
• Stage IVC Oral Cavity Squamous Cell Carcinoma
• Stage IVC Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Paclitaxel — DRUG
  Given IV
• Carboplatin — DRUG
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies how well nivolumab, carboplatin, and paclitaxel work in treating patients with stage III-IV head and neck squamous cell carcinoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab, carboplatin, and paclitaxel may work better in treating patients with head and neck squamous cell carcinoma.

Key Dates

Start date

Nov 13, 2017

Status verified

Apr 2025

Primary completion

Oct 6, 2020

Completion

Oct 6, 2020

Study Design

Enrollment

34 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (nivolumab, paclitaxel, carboplatin)
  Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Pathologic Complete Response Rate [ Time Frame: Up to 26 months ]

Locations (3)

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