Study on the Safety and Tolerability of Nivolumab Alone or with Relatlimab or Ipilimumab for Head and Neck Cancer

Sponsor: Dan Zandberg

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04080804

Provider View

This clinical trial is testing the safety and effects of using Nivolumab, alone or combined with other drugs, to boost the immune system's ability to fight head and neck cancer before surgery.

Patient Parameters

Program Overview

The purpose of this study is to see if adding drugs like Relatlimab or Ipilimumab to Nivolumab can help the immune system better fight head and neck cancer. These drugs are given to patients with locally advanced head and neck cancer that can be surgically removed. The study aims to find out if this combination can improve treatment outcomes.

Description

This study involves using immunotherapy drugs, which have been well-tolerated in patients with recurring or spreading cancer. The study focuses on patients with newly diagnosed, locally advanced head and neck cancer who have not received prior treatment. These patients are eligible for surgery as determined by a team of specialists. Patients with autoimmune diseases or those who have used immune-modulating drugs before are not eligible.

Relatlimab is given through an IV at a dose of 480 mg on Day 1 (and again on Day 28 if surgery is delayed). Nivolumab is also given through an IV at a dose of 480 mg on Day 1 (and on Day 28 if surgery is delayed) when used alone or with Relatlimab. When combined with Ipilimumab, Nivolumab is given at 3 mg/kg every two weeks on Day 1 and Day 14 (and on Day 28 if surgery is delayed and the cancer is stable). Ipilimumab is given at 1 mg/kg through an IV only on Day 1. Patients will have a biopsy and CT scan before starting treatment. Surgery will occur about 4 weeks later, with another CT scan done just before surgery. Patients will be monitored from the time of biopsy until 6 months after surgery.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 years or older.
  • Diagnosed with stage III or IVA head and neck squamous cell carcinoma, not previously treated.
  • Tumor must be accessible for a biopsy before treatment.
  • Have specific test results for LAG-3 and PD-L1.
  • Heart function must be at least 50% as shown by specific tests.
  • Women who can become pregnant must avoid pregnancy during the study and use effective birth control.
  • Men must use effective birth control and avoid donating sperm during the study.
  • Tumors located in the oral cavity, oropharynx, hypopharynx, or larynx.
  • Eligible for surgery.
  • ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Signed informed consent.

Exclusion Criteria

  • Previous radiation, chemotherapy, cancer vaccine, or immunotherapy.
  • Severe allergic reaction to a monoclonal antibody.
  • High levels of specific heart markers unless cleared by a doctor.
  • Evidence of cancer spread to distant parts of the body.
  • History of head and neck cancer treated less than 5 years ago.
  • History of heart inflammation.
  • Previous treatment with LAG-3 targeted drugs.
  • Known history of Hepatitis B or C.
  • Active or history of autoimmune diseases like lupus or rheumatoid arthritis.
  • Psychiatric or social issues that limit study participation.
  • Discovery of a second primary tumor during examination.

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