Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck
NCT03854032 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-06-06
Summary
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.
Conditions
- Lip
- Oral Cavity Squamous Cell Carcinoma
- Pharynx
- Larynx
- Squamous Cell Carcinoma
Interventions
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
IDO1 Inhibitor BMS-986205
Given PO
- PROCEDURE
-
Therapeutic Conventional Surgery
Undergo Surgery
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
- collaborator INDUSTRY
-
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Adam Luginbuhl, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-09
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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