Nivolumab + BMS986205 for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well nivolumab works, with or without BMS986205, in treating patients with stage II-IV squamous cell cancer of the head and neck. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. BMS986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab with BMS986205 may work better than nivolumab alone in treating patients with squamous cell cancer of the head and neck.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic steroid therapy or immunosuppressive therapy, you may need to stop these at least 14 days before starting the trial.
Is the combination of Nivolumab and BMS-986205 safe for treating head and neck cancer?
What makes the drug Nivolumab + BMS986205 unique for head and neck cancer?
Nivolumab (Opdivo) is unique because it is an immunotherapy drug that targets the PD-1 protein, helping the immune system attack cancer cells, and it is specifically approved for patients with head and neck cancer who have not responded to platinum-based treatments. The combination with BMS986205, although not directly mentioned in the research, suggests a novel approach potentially enhancing the immune response compared to using Nivolumab alone.678910
What data supports the effectiveness of the drug Nivolumab + BMS986205 for head and neck cancer?
Nivolumab has shown a clear clinical benefit for patients with recurrent or metastatic head and neck cancer, improving survival and quality of life, especially in patients with certain biomarkers. Additionally, combining nivolumab with other drugs has been successful in treating similar cancers, suggesting potential effectiveness when combined with BMS986205.37101112
Who Is on the Research Team?
Adam Luginbuhl, MD
Principal Investigator
Sidney Kimmel Cancer Center at Thomas Jefferson University
Are You a Good Fit for This Trial?
This trial is for adults with stage II-IV squamous cell cancer of the head and neck, including oral cavity and larynx cancers. Candidates must be fit for surgery, have a good performance status (able to carry out daily activities), normal organ function, and not be pregnant or breastfeeding. Men must use contraception during treatment and for 7 months after. People with HIV/AIDS, active hepatitis B/C, severe autoimmune diseases requiring recent treatment, other current cancers (with some exceptions), or history of certain blood disorders are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab with or without BMS986205 for up to 5 weeks, followed by surgery based on treatment response
Surgery
Surgery is performed based on treatment response after 5 weeks for Arm I and 4 weeks for Arm II
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IDO1 Inhibitor BMS-986205
- Nivolumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania