Combining Radiation Therapy with Immunotherapy for Treating Metastatic Squamous Cell Carcinoma of the Head and Neck

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05721755

Provider View

This study is testing whether adding radiation therapy to the immunotherapy drug pembrolizumab, after initial chemotherapy, can better treat head and neck cancer that has spread to other parts of the body. The trial compares this combination to the standard treatment of pembrolizumab alone.

Patient Parameters

Program Overview

This phase III trial is exploring if combining radiation therapy with the immunotherapy drug pembrolizumab is more effective than using pembrolizumab alone for treating metastatic squamous cell carcinoma of the head and neck. Pembrolizumab helps the immune system attack cancer cells by blocking a protein called PD-1 on T-cells. Radiation therapy uses high-energy rays to kill cancer cells. The study aims to see if this combination can improve treatment outcomes for patients whose cancer has spread beyond its original site.

Description

The main goal of this study is to compare the overall survival of patients receiving pembrolizumab with radiation therapy to those receiving pembrolizumab alone, after initial chemotherapy. Researchers will also look at how long patients live without the cancer getting worse, the time until treatment failure, and any severe side effects from the treatment.

The study will also assess the quality of life for patients, including how long it takes for their health to decline and changes in their well-being during the study.

Participants will be divided into two groups:

  • Group A: Patients will receive pembrolizumab with chemotherapy drugs (carboplatin and paclitaxel, or cisplatin and fluorouracil) and then continue with pembrolizumab and radiation therapy.
  • Group B: Patients will receive pembrolizumab with chemotherapy drugs and then continue with pembrolizumab alone.

Throughout the study, patients will undergo various scans, such as CT, PET/CT, and MRI, to monitor the cancer's response to treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic squamous cell carcinoma of the head and neck, with active disease in both the head and neck and other body parts.
  • Can have had surgery for the primary cancer, but must have remaining or returning disease.
  • Must have 4 or fewer metastatic sites before starting treatment.
  • Must have a performance status of 0-1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Must be able to understand and sign a consent form.
  • Must have measurable disease as shown by recent scans.
  • Must meet specific blood count and organ function requirements.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C patients must have controlled or treated infections.
  • Must not expect to conceive or father children during the study and for 4 months after treatment.
  • Must have completed 3 cycles of initial chemotherapy and have stable or responding disease for randomization.

Exclusion Criteria

  • Must not have had prior radiation therapy to the head and neck.
  • Must not have an active autoimmune disease requiring treatment in the past 2 years.
  • Must not be pregnant or breastfeeding.
  • Must not have received a live vaccine within 30 days before starting the study.

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