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

Summary

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.

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

Interventions

DRUG

Paclitaxel

Given IV

DRUG

Carboplatin

Given IV

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Sidney Kimmel Cancer Center at Thomas Jefferson University

  lead OTHER

Principal Investigators

• Jennifer Johnson, MD, PhD · Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-13

Primary Completion

2020-10-06

Completion

2020-10-06

FDA Drug

Yes

Countries

• United States

Study Locations