Comparing Chemotherapy and Immunotherapy with Radiation for Head and Neck Cancer

Sponsor: Loren Mell, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03383094

Provider View

This clinical trial is comparing the effects of using the experimental drug pembrolizumab with radiation therapy against the standard treatment of cisplatin chemotherapy with radiation therapy in patients with head and neck cancer.

Patient Parameters

Program Overview

The study aims to find out if using pembrolizumab, an experimental drug, along with radiation therapy is more effective than the traditional treatment of cisplatin chemotherapy with radiation therapy for patients with head and neck squamous cell carcinoma (HNSCC). The main goal is to see which treatment helps patients live longer without the cancer getting worse.

Description

This study involves patients with a specific type of head and neck cancer that is considered intermediate to high risk. It will compare two treatment approaches: one using pembrolizumab with radiation therapy, and the other using cisplatin chemotherapy with radiation therapy. The study will look at how long patients live without their cancer progressing. Participants will be randomly assigned to one of the two treatment groups and will receive their assigned treatment. The study will take place across multiple locations and is open-label, meaning both the researchers and participants know which treatment is being given.

Eligibility Criteria

Inclusion Criteria

  • Have a specific type of head and neck cancer that is p16-positive, affecting areas like the throat, voice box, or mouth.
  • Have cancer that is considered high or intermediate risk based on certain medical criteria.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have good blood, kidney, and liver function based on recent tests.
  • Women who can have children must have a negative pregnancy test and agree to use birth control during the study.
  • Men must agree to use birth control during the study.

Exclusion Criteria

  • Have had another cancer in the past 3 years, except for certain skin or prostate cancers.
  • Have had previous radiation, chemotherapy, or immunotherapy for head and neck cancer.
  • Have had major surgery to remove the cancer.
  • Have cancer that has spread to other parts of the body.
  • Have serious health conditions like recent heart problems, severe infections, or liver issues.
  • Have a weakened immune system or certain autoimmune diseases.
  • Are pregnant or breastfeeding, or planning to have children during the study.
  • Have had previous treatment with similar drugs to pembrolizumab.
  • Have active infections like HIV, Hepatitis B, or Hepatitis C.
  • Have received a live vaccine recently.

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