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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Carboplatin — DRUG
  Given IV
• Cemiplimab — BIOLOGICAL
  Given IV
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Paclitaxel — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Salvage Surgery — PROCEDURE
  Undergo standard of care salvage surgery

Study Details

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.

Key Dates

Start date

Apr 24, 2026

Status verified

Apr 2026

Primary completion

Feb 1, 2033

Completion

Feb 1, 2033

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (Salvage surgery)
  Patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
• Experimental: Arm 2 (Chemotherapy, salvage surgery)
  Patients receive paclitaxel IV and carboplatin IV on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
• Experimental: Arm 3 (Chemo-immunotherapy, salvage surgery)
  Patients receive paclitaxel IV, carboplatin IV and cemiplimab IV, over 30 minutes, on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years ]

Locations (51)

Find similar trials in Tucson, AZ

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