Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

Summary

This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.

Conditions

• Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Locally Recurrent Head and Neck Squamous Cell Carcinoma
• Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Locally Recurrent Laryngeal Squamous Cell Carcinoma
• Locally Recurrent Oral Cavity Squamous Cell Carcinoma
• Locally Recurrent Oropharyngeal Squamous Cell Carcinoma
• Stage II Laryngeal Cancer AJCC v8
• Stage II Lip and Oral Cavity Cancer AJCC v8
• Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage III Laryngeal Cancer AJCC v8
• Stage III Lip and Oral Cavity Cancer AJCC v8
• Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVA Laryngeal Cancer AJCC v8
• Stage IVA Lip and Oral Cavity Cancer AJCC v8
• Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVB Laryngeal Cancer AJCC v8
• Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

BIOLOGICAL

Cemiplimab

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Salvage Surgery

Undergo standard of care salvage surgery

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Nabil F Saba · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-24

Primary Completion

2033-02-01

Completion

2033-02-01

FDA Drug

Yes

Countries

• United States

Study Locations