← Back to Search

Checkpoint Inhibitor

Nivolumab + BMS986205 for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Adam Luginbuhl, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Any stage 2 or greater HNSCC (American Joint Committee on Cancer [AJCC] 8th edition) of the 1) oral cavity, 2) larynx, 3) hypopharynx, 4) nasal cavity/paranasal sinuses or 5) stage 1 oropharyngeal with lymphadenopathy. Patients with resectable disease that is amenable to surgery are eligible. Patient must have been determined to be candidates for surgical resection by a multi-disciplinary team including a surgeon, a medical oncologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial studies nivolumab with or without BMS986205 to treat patients with squamous cell cancer of the head and neck. Nivolumab is an immunotherapy that may help the body's immune system attack the cancer. BMS986205 is a drug that may stop the growth of tumor cells. Giving nivolumab with BMS986205 may work better than nivolumab alone.

Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing the effectiveness of Nivolumab alone or combined with an enzyme inhibitor called BMS986205 in treating head and neck cancer. Nivolumab is an immunotherapy drug that helps the immune system attack cancer cells. BMS986205 aims to block enzymes that tumor cells need to grow. The combination may improve outcomes compared to using Nivolumab by itself.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs which can cause symptoms like coughing or diarrhea; skin reactions; hormonal gland problems leading to changes in mood or energy levels; infusion-related reactions like fever or chills; fatigue; liver issues indicated by yellowing skin/eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have stage 2 or higher head and neck cancer and am a candidate for surgery.
Select...
I will use a condom during the trial, even if I've had a vasectomy or my partner is pregnant.
Select...
My cancer is a type of head and neck cancer known as squamous cell carcinoma.
Select...
My kidney function, measured by GFR, is adequate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response
Secondary outcome measures
Change in immune cell polarization (Th1/Th2; M1/M2) in peripheral blood and tumor specimens
Change in inflammatory markers
Change in prevalence of intratumoral immune cell populations (effector T cells [Teff], regulatory T cells [Treg], and tumor-associated macrophages [TAM] in patients treated with Nivolumab and BMS986205 as compared to patients treated with Nivolumab alone
+7 more
Other outcome measures
Change in exosome abundance and composition in the peripheral blood of patients both before and after exposure to both nivolumab and BMS986205 and nivolumab alone
Changes in tumor volume and rates of radiographic response
Intratumoral T-cell receptor (TCR) repertoire and diversity
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (BMS986205, nivolumab)Experimental Treatment4 Interventions
Patients receive IDO1 inhibitor BMS-986205 PO QD. Beginning week 2, patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients showing a treatment response receive IDO1 inhibitor BMS-986205 PO QD for 4 additional weeks and receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 10. Those without a treatment response after 5 weeks undergo surgery within 7 days.
Group II: Arm II (nivolumab)Active Control3 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients showing treatment response after 4 weeks receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 9. Those without a treatment response after 4 weeks undergo surgery within 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,669 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,455 Total Patients Enrolled
Adam Luginbuhl, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
3 Previous Clinical Trials
89 Total Patients Enrolled
1 Trials studying Pharynx
9 Patients Enrolled for Pharynx

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03854032 — Phase 2
Pharynx Research Study Groups: Arm I (BMS986205, nivolumab), Arm II (nivolumab)
Pharynx Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03854032 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03854032 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the common application of BMS-986205?

"BMS-986205, an IDO1 Inhibitor, is most often used to treat malignant neoplasms. However, it can also be effective in treating other conditions like unresectable melanoma or squamous cell carcinoma."

Answered by AI

How many people have enrolled in this clinical trial so far?

"This study is no longer enrolling new patients. The trial began on 4/9/2019 and the most recent update was on 11/16/2022. 2776 other trials are currently enrolling patients that have larynx cancer and 747 studies are recruiting participants for IDO1 Inhibitor BMS-986205 intervention specifically."

Answered by AI

What makes this research unique compared to other projects?

"First researched in 2010, IDO1 Inhibitor BMS-986205 initially went through a small Phase 1 clinical trial. After the initial study, which had 127 participants and was sponsored by Medarex, the medication received drug approval for further research. As of now, there are 747 active trials in 50 countries and 2347 cities."

Answered by AI

What are the previous findings of BMS-986205's impact on IDO1?

"BMS-986205 was first studied as an IDO1 inhibitor at H. Lee Moffitt Cancer Center and Research Institute in 2010. There are now 466 completed clinical trials, with 747 more currently underway--many of which taking place near Philadelphia, Pennsylvania."

Answered by AI

What are the risks associated with taking BMS-986205?

"There is some evidence attesting to the IDO1 Inhibitor BMS-986205's safety, but its efficacy has yet to be proven in clinical trials. Consequently, it received a score of 2."

Answered by AI

Are there any vacancies in this ongoing clinical trial?

"As of right now, this particular clinical trial is not looking for more participants. It was originally posted on April 9th, 2019 but the most recent update was on November 16th, 2022. There are 2776 other trials recruiting patients with larynx and 747 trials enrolling IDO1 Inhibitor BMS-986205 patients if you're interested in alternative studies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck
2019. "Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03854032.
~11 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top