Treatment De-intensification Protocol for Patients with HPV+ Head and Neck Cancer

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Clinical Trial: Head and Neck Cancer

Treatment De-intensification Protocol for Patients with Human Papilloma Virus (HPV+) Head and Neck Cancer

Lay Title: Combination of Low-Dose Focused Radiotherapy, Immunotherapy, and Transoral Robotic Surgery in HPV+ Head and Neck Cancer

Technical Title: Phase Ib/II Trial of Stereotactic Body Radiotherapy (SBRT) in Combination with Immunotherapy Prior to Transoral Robotic Surgery (TORS) for HPV+ Squamous Cell Carcinoma of the Head and Neck (SCCHN) 

Basic Information

This study is designed to evaluate the safety and efficacy of a novel treatment paradigm in HPV+ head and neck cancer. Instead of conventional options of surgery, chemotherapy, and large-field radiotherapy, which can cause significant long-term toxicities, this protocol uses focused radiotherapy, immunotherapy, and robotic surgery. Focused radiotherapy is delivered to only the visible tumor over the course of a single week while accompanied by immunotherapy. Transoral robotic surgery will be completed 6-8 weeks later, followed by 4 additional rounds of immunotherapy.

This study hypothesizes that this novel treatment regimen will cause much less long-term toxicity while maintaining excellent cancer control. The study has two parts. The first portion is designed to make sure that the new combination is safe. The second, larger portion is designed to make sure that short and long-term side-effects are significantly reduced and cancer control is not compromised.  

Research Procedures

Phase Ib:
Stereotactic body radiotherapy (SBRT) of 25Gy divided in 5 daily sessions to the visible tumor. This is accompanied by one infusion of Durvalumab during, and one infusion of Durvalumab after radiotherapy. Six to eight weeks later, subjects will complete transoral robotic surgery followed by four additional cycles of Durvalumab. If the above procedure is found to be safe, the next cohort of subjects will have their first two cycles of Durvalumab accompanied by Tremelimumab, with all other procedures remaining the same.

Phase II:
Once the safety of this protocol is established, a much larger group of subjects will complete the treated with the procedures described above with close monitoring for both toxicities and disease recurrence.

Durvalumab is an FDA approved drug for other diseases, but not yet FDA approved for use in this manner.
Tremelimumab is not yet received FDA approval. Thus, this procedure is only available as part of a rigorous research study under institutional and FDA supervision.  

Eligibility Criteria (Basic):

  • Must have biopsy proven HPV+ squamous cell carcinoma of the head and neck
  • Must have disease that is surgically operable
  • Must not have received prior definitive therapy

Other eligibility criteria exist.  

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