Study on Nivolumab With or Without Ipilimumab for Oral Cavity Squamous Cell Carcinoma

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT02919683

Provider View

This clinical trial is exploring the use of two investigational drugs, Nivolumab and Ipilimumab, to treat squamous cell carcinoma of the oral cavity. The study aims to see if these drugs can help reduce the cancer before surgery.

Patient Parameters

Program Overview

This study is testing two drugs, Nivolumab and Ipilimumab, to see if they can help treat squamous cell carcinoma in the mouth. These drugs are a type of immunotherapy, which means they help your immune system fight cancer. Nivolumab and Ipilimumab are already used to treat other types of cancer, but this study is looking at how well they work for mouth cancer before surgery.

Description

This is a Phase II clinical trial, which means it is testing how safe and effective the drugs are for treating a specific disease. In this case, the study is looking at how well Nivolumab, alone or with Ipilimumab, works before surgery to remove oral cavity cancers. Both drugs are types of immunotherapy that help the immune system attack cancer cells. They have been shown to work in other cancers, like melanoma, but are not yet approved for head and neck cancers. This study will test if these drugs can shrink the cancer before surgery and help prevent it from coming back.

Eligibility Criteria

Inclusion Criteria

  • Must have squamous cell carcinoma of the oral cavity that is at least 2 cm in size or has spread to nearby lymph nodes.
  • Must be 18 years or older and able to handle the treatment and surgery.
  • Must have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must be a candidate for surgery to remove the cancer.
  • Women who can become pregnant must use effective birth control during the study and for 23 weeks after the last dose of the study drug.
  • Men must use effective birth control if they are sexually active with women who can become pregnant, for 31 weeks after the last dose.
  • Must have normal organ and bone marrow function as shown by specific blood tests.

Exclusion Criteria

  • Cancer that has spread to distant parts of the body, like below the collarbone or to the brain.
  • Previous treatment with drugs that block PD-1 or CTLA-4 pathways.
  • Uncontrolled illnesses like infections, heart failure, or psychiatric conditions that could interfere with the study.
  • History of another cancer unless it has been in remission for at least 2 years.
  • Previous radiation to the head and neck or chemotherapy in the last 2 years.
  • History of lung diseases like pneumonitis.
  • Active autoimmune diseases requiring treatment in the last 2 years.
  • Positive for HIV, hepatitis B, or hepatitis C.
  • Unable to attend follow-up visits.
  • Taking other cancer treatments during the study.
  • Need for high-dose steroids or other immune-suppressing drugs.
  • Allergy to study drugs or severe reactions to monoclonal antibodies.
  • Recently received a live vaccine.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02115BostonMassachusetts

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