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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

Must not have

Patients with prior history of ILD or non-infectious pneumonitis that required steroids

Patients with recurrent head and neck cancer treated previously with chemotherapy, radiation or immunotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

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.

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.

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

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I can take care of myself and am up and about more than half of my waking hours.

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I have stage 2 or higher head and neck cancer and am a candidate for surgery.

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I will use a condom during the trial, even if I've had a vasectomy or my partner is pregnant.

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My cancer is a type of head and neck cancer known as squamous cell carcinoma.

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My kidney function, measured by GFR, is adequate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung inflammation or pneumonitis treated with steroids before.

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My head or neck cancer has returned after treatment with chemotherapy, radiation, or immunotherapy.

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I am not allergic to any components of the study treatment, including BMS-986205.

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I have not taken BMS-986205 or any IDO1 inhibitors before.

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My cancer originates from the nasopharynx, salivary glands, or skin.

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I have lung inflammation or scarring.

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I have a G6PD deficiency.

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I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

~9870

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

452 Previous Clinical Trials

148,842 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,652 Previous Clinical Trials

4,130,704 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

~8 spots leftby Dec 2025

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