Study on Cetuximab and Nivolumab for Recurrent or Metastatic Head and Neck Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03370276

Provider View

This clinical trial is exploring whether combining two approved cancer treatments, Cetuximab and Nivolumab, can help patients with advanced head and neck cancer that has returned or spread. Both drugs are already used separately for this type of cancer.

Patient Parameters

Program Overview

The aim of this study is to see if using Cetuximab and Nivolumab together can benefit people with advanced head and neck squamous cell carcinoma (HNSCC). These drugs are already approved by the FDA for treating this cancer type when used individually. Researchers want to find out if the combination can improve outcomes for patients whose cancer has come back or spread.

Description

The study is divided into two phases:

Phase I: Participants will receive treatment every two weeks for 12 cycles, with each cycle lasting four weeks. Initially, Cetuximab is given alone two weeks before the first cycle. From the first cycle onwards, both Cetuximab and Nivolumab are given together. Researchers will monitor for any serious side effects during the first cycle.

Phase II: Once the best dose of Cetuximab is determined in Phase I, more participants will be enrolled to further test the combination.

Follow-Up: Participants will be monitored for two years after treatment ends. Imaging tests will be done every eight weeks during the first six cycles and every 12 weeks during the last six cycles to check the cancer's status. Regular follow-ups with doctors will continue as part of standard care.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma in areas like the mouth, throat, sinuses, or voice box. Cancer in neck lymph nodes is included if a specific test (p16) is positive.
  • Cancer must be advanced (stage III/IV) and not treatable with surgery or radiation aimed at curing it.
  • Cancer must have worsened after at least one previous treatment, or if standard chemotherapy is not suitable, this study can be the first treatment.
  • Must not have had systemic therapy for advanced cancer unless it was part of a treatment aimed at curing a local recurrence.
  • Must have at least one tumor that can be measured.
  • Must be 18 years or older.
  • Expected to live more than three months.
  • Must be in relatively good health, with a performance status of 0 to 2.
  • Must have normal organ function based on specific blood tests.
  • If sexually active, must use effective birth control. Women of childbearing potential need a negative pregnancy test before joining.
  • Must understand and agree to the study by signing a consent form.

Exclusion Criteria

  • Severe skin reactions from previous EGFR therapy.
  • Severe reactions from previous anti-PD1 therapy.
  • Cancer in neck lymph nodes that is p16 negative.
  • Cancer in the nasopharynx or salivary glands.
  • Recent chemotherapy, biological therapy, or radiation within four weeks before joining.
  • Major surgery within four weeks before joining.
  • Recent palliative radiation within two weeks before joining.
  • Recent use of other experimental treatments.
  • Untreated or symptomatic brain cancer spread.
  • Serious ongoing illnesses or conditions that could interfere with the study.
  • Need for high-dose steroids or other immune-suppressing drugs recently.
  • Serious heart conditions or recent heart attack.
  • Uncontrolled high blood pressure.
  • Previous treatment with both Cetuximab and a PD-1/PD-L1 inhibitor together.
  • Allergic reactions to similar drugs.
  • Pregnant or breastfeeding.
  • Active HIV, Hepatitis B, or Hepatitis C infection.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.