Study on Nivolumab and BMS986205 for Treating Stage II-IV Head and Neck Squamous Cell Cancer

Sponsor: Thomas Jefferson University

Sponsor score: 0

ClinicalTrials ID:NCT03854032

Provider View

This clinical trial is exploring how well the drug nivolumab works, with or without another drug called BMS986205, in treating patients with stage II-IV squamous cell cancer of the head and neck. The study aims to see if combining these drugs can better help the immune system fight cancer and stop tumor growth.

Patient Parameters

Program Overview

This study is testing the effectiveness of nivolumab, an immunotherapy drug, with or without BMS986205, in treating patients with advanced squamous cell cancer of the head and neck. Nivolumab helps the immune system attack cancer cells, while BMS986205 may block enzymes that help tumors grow. Researchers want to find out if using both drugs together works better than nivolumab alone.

Description

The main goal of this study is to see how well the combination of BMS986205 and nivolumab works compared to nivolumab alone in shrinking tumors in the head and neck area. Researchers will look at how the drugs affect the immune system's ability to fight cancer and how they impact the tumor environment. They will also study the safety and side effects of the treatment.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take BMS986205 by mouth daily and receive nivolumab through an IV once a week for up to 5 weeks. If the treatment is working, they will continue with BMS986205 and nivolumab for 4 more weeks before having surgery.
  • Group 2: Will receive nivolumab through an IV once a week. If the treatment is working after 4 weeks, they will continue with nivolumab for another week before having surgery.

After the treatment, participants will be monitored for 12 months to check their health and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell cancer of the head and neck (HNSC) at stage II or higher.
  • Cancer located in the oral cavity, larynx, hypopharynx, nasal cavity, paranasal sinuses, or stage I oropharyngeal cancer with lymph node involvement.
  • Cancer must be operable and suitable for surgery.
  • Good overall health with an ECOG performance status of 0-2.
  • Adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use condoms and avoid sperm donation during and after the study.
  • Ability to understand and sign a consent form.

Exclusion Criteria

  • Have nasopharyngeal carcinoma, salivary gland, or skin cancer.
  • Have previously treated head and neck cancer with chemotherapy, radiation, or immunotherapy.
  • Have severe allergies to monoclonal antibodies or study drugs.
  • Have certain genetic or blood disorders that increase risk of methemoglobinemia.
  • Have a history of serotonin syndrome.
  • Have active lung disease or history of lung disease requiring steroids.
  • Have received BMS-986205 or similar drugs before.
  • Have other active cancers, except for certain skin or bladder cancers.
  • Have an autoimmune disease requiring treatment in the past 3 months.
  • Have uncontrolled illnesses or infections.
  • Are pregnant or breastfeeding.
  • Have HIV, active hepatitis B or C, or other serious infections.
  • Have received a live vaccine within 30 days before starting the study.

Locations

FACILITYZIPCITYSTATE
Ohio State University43210ColumbusOhio
Sidney Kimmel Cancer Center at Thomas Jefferson University19107PhiladelphiaPennsylvania

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