A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features

Summary

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor 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. Carboplatin is also 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

Description

Eligibility

Age range

18–79 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Carboplatin

  Given IV

• Drug
  Cisplatin

  Given IV

• Procedure
  Computed Tomography

  Undergo CT

• Radiation
  Intensity-Modulated Radiation Therapy

  Undergo IMRT

• Procedure
  Magnetic Resonance Imaging

  Undergo MRI

• Biological
  Pembrolizumab

  Given IV

• Radiation
  Proton Beam Radiation Therapy

  Undergo PBRT

Locations (177)