Study on SBRT with or without Pembrolizumab for Recurrent or New Head and Neck Cancer

Sponsor: RTOG Foundation, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT03546582

Provider View

This clinical trial is testing whether adding the drug pembrolizumab to a type of precise radiation therapy called SBRT can help improve outcomes for patients with recurrent or new head and neck cancer.

Patient Parameters

Program Overview

This study aims to find out if combining pembrolizumab, an immunotherapy drug, with Stereotactic Body Radiation Therapy (SBRT) can help patients with recurrent or new head and neck cancer live longer without the disease getting worse. The trial includes a safety phase to ensure the treatment is safe, followed by a phase where patients are randomly assigned to receive either SBRT with pembrolizumab or SBRT alone.

Description

The study is divided into two parts:

Safety Phase: This part checks if it's safe to add pembrolizumab to SBRT for patients with recurrent or new head and neck cancer. Patients will receive SBRT over two weeks and then pembrolizumab every three weeks for up to two years.

Phase II: Patients are randomly assigned to one of two groups:

  • Group 1: Patients receive SBRT over two weeks and then pembrolizumab every three weeks for up to two years.
  • Group 2: Patients receive SBRT over two weeks. If their cancer progresses within two years, they can switch to receive pembrolizumab for up to two years.

After finishing the treatment, patients will have follow-up visits every six months for three years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with recurrent or new head and neck squamous cell carcinoma that cannot be surgically removed.
  • Surgery would pose high risks or cause significant complications.
  • New primary cancer defined by specific criteria, such as developing more than six months after the first cancer or being distinct from the first cancer.
  • Prior radiation to the head and neck.
  • Cancer limited to a single site or adjacent sites with a maximum tumor size of less than 7.5 cm.
  • Recent biopsy or surgery with remaining visible cancer.
  • Medical exams and imaging tests within 56 days before joining the study.
  • Age 18 or older, open to all genders.
  • Meet specific blood and organ function criteria.
  • Negative pregnancy test for women of childbearing potential.
  • Provide informed consent to participate.

Exclusion Criteria

  • Cancer that has spread to distant parts of the body.
  • Tumors involving more than 180 degrees of the carotid artery with skin or mucosal involvement.
  • Tumors requiring treatment of multiple separate areas.
  • Prior radiation to the primary tumor within six months.
  • Recent systemic therapy or investigational treatment.
  • Previous treatment with certain immunotherapy drugs.
  • Active infections or significant medical conditions that could interfere with the study.
  • Pregnant or nursing women, or those not using effective contraception.

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