Study on Cemiplimab and CDX-1140 Before Surgery for Stage III-IV Head and Neck Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06980038

Provider View

This clinical trial is testing whether adding the drug CDX-1140 to cemiplimab before surgery is more effective than using cemiplimab alone in treating patients with advanced head and neck cancer.

Patient Parameters

Program Overview

This study is exploring if combining two drugs, cemiplimab and CDX-1140, before surgery can better control stage III-IV head and neck cancer compared to using cemiplimab alone. Both drugs are types of immunotherapy, which help the body's immune system fight cancer. The goal is to see if this combination can shrink tumors more effectively, potentially allowing for less tissue removal during surgery.

Description

The main goal of this study is to see if the combination of CDX-1140 and cemiplimab can reduce the amount of cancer left after treatment to 10% or less. Researchers will also look at how well the combination works overall, how safe it is, and how patients tolerate it. They will study changes in the cancer's genetic makeup and how the immune system responds to the treatment.

Participants will be randomly assigned to one of two groups. One group will receive cemiplimab alone, while the other group will receive both cemiplimab and CDX-1140. Both groups will then have surgery to remove the cancer and receive standard follow-up care. Throughout the study, participants will have scans, biopsies, and blood tests to monitor their progress. After treatment, follow-up visits will occur at specific intervals to check on the patients' health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have stage III-IV head and neck cancer that can be surgically removed.
  • Cancer must be measurable by scans or exams.
  • Must be 18 years or older.
  • Must have a good performance status, meaning able to carry out daily activities with some limitations.
  • Must have adequate blood counts and organ function.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C patients must have controlled or cured infections.
  • Women and men must use effective birth control during and after treatment.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have an autoimmune disease or organ transplant history.
  • Have used immunosuppressive medication recently.
  • Have had previous treatment with similar immunotherapy drugs.
  • Have lung disease or other active cancers that could interfere with the study.
  • Have not recovered from side effects of previous cancer treatments.
  • Are pregnant or breastfeeding, due to potential risks to the baby.

Locations

FACILITYZIPCITYSTATE
JHU Sidney Kimmel Comprehensive Cancer Center LAO21231BaltimoreMaryland

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