Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Thomas Jefferson University
Study ID
NCT03854032
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Given IV
  • IDO1 Inhibitor BMS-986205 — BIOLOGICAL
    Given PO
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo Surgery
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Apr 9, 2019
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (BMS986205, nivolumab)
    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.
  • Active Comparator: Arm II (nivolumab)
    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.

Primary Outcome Measure

Objective Response [ Time Frame: At 5 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210-
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Columbus, OH

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Ohio State University· Columbus, OHSidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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