Study on Nivolumab and Lirilumab Before and After Surgery for Head and Neck Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT03341936

Provider View

This clinical trial is exploring the use of two immunotherapy drugs, nivolumab and lirilumab, to treat squamous cell carcinoma of the head and neck that has returned in the local area. The study involves using these drugs before and after surgery to see if they can help control the cancer.

Patient Parameters

Program Overview

This study is testing a combination of two immunotherapy drugs, nivolumab and lirilumab, to see if they can effectively treat squamous cell carcinoma of the head and neck that has come back in the local area. Immunotherapy helps the body's immune system attack cancer cells. Nivolumab is already approved for treating this type of cancer, while lirilumab is still being studied.

Description

This is a Phase II clinical trial, which means it is testing how safe and effective the combination of nivolumab and lirilumab is for treating head and neck cancer. These drugs are types of immunotherapy, which work by boosting the body's immune system to fight cancer cells. Nivolumab is already approved for treating recurrent or metastatic squamous cell carcinoma of the head and neck, but lirilumab is still under investigation. The study aims to see if using these drugs before and after surgery can help control the cancer more effectively.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of squamous cell carcinoma of the head and neck that has returned in the local area.
  • Must be eligible for surgery to remove the cancer.
  • Willing to provide blood and tissue samples for research.
  • Must have been cancer-free for more than 8 weeks after initial treatment before the cancer returned.
  • Any HPV status or smoking history is allowed.
  • Must be 18 years or older.
  • Must be in relatively good health with a performance status score of 2 or less.
  • Must have normal organ and bone marrow function based on specific blood tests.
  • Must be able to understand and sign a consent form.
  • Women who can become pregnant must use effective birth control during the study and for 5 months after the last dose of nivolumab.
  • Women must have a negative pregnancy test before starting treatment.
  • Men must use effective birth control if they are sexually active with women who can become pregnant, for 7 months after the last dose of treatment.

Exclusion Criteria

  • Cannot have significant autoimmune diseases, except for stable Hashimoto thyroiditis.
  • Cannot be on long-term high-dose steroids before joining the study.
  • Cannot have had chemotherapy or radiotherapy within 4 weeks before starting the study.
  • Cannot have been treated with certain types of immunotherapy before.
  • Cannot have known brain metastases.
  • Cannot have uncontrolled illnesses like active infections, heart failure, or psychiatric conditions that would interfere with the study.
  • Cannot have HIV or active hepatitis B or C infections.
  • Cannot have a history of lung diseases like pneumonitis.
  • Cannot have received a live vaccine within 30 days before starting the study.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts

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